| Trial | Phase | Enrollment | Study Type | Start Date | Status |
|---|
| Efficacy & Safety of Clindamycin Phosphase 1.2% and Tretinoin 0.025% Gel vs. Vehicle for the Treatment of Acne and Acne-Induced Post Inflammatory Hyperpigmentation in Patients With Skin of Color[NCT01111994] | Phase 4 | 30 participants (Anticipated) | Interventional | 2009-11-30 | Active, not recruiting |
| Phase III Comparative Study of Efficacy of 10 mg Dequalinium Chloride (Fluomizin) in the Local Treatment of Bacterial Vaginosis[NCT01125410] | Phase 3 | 321 participants (Actual) | Interventional | 2007-01-31 | Completed |
| Investigating Anti-inflammatory Effects of Topical Antibiotics in an LPS Skin Challenge Model[NCT03779360] | | 32 participants (Actual) | Interventional | 2018-10-12 | Completed |
| The Role of Antibiotics in the Reduction of Infectious Complications in Tube Thoracotomy Management of Traumatic Hemopneumothorax: A Prospective, Double-Blinded Study[NCT01127880] | Phase 2/Phase 3 | 50 participants (Actual) | Interventional | 2005-07-31 | Completed |
| A Randomized, Double-Blind, Multiple-Site, Placebo-Controlled Study Comparing Two 1% Clindamycin/5% Benzoyl Peroxide Topical Gel Formulations in the Treatment of Moderate to Severe Acne Vulgaris[NCT01044264] | | 602 participants (Actual) | Interventional | 2007-12-31 | Completed |
| A Phase IV, Open-Label Study Evaluating the Use of Solodyn (Minocycline HCL Extended-Release Tablets), Ziana, and Triaz Foaming Cloths as Combination Acne Therapy Prior to Treatment With Isotretinoin[NCT01206348] | Phase 4 | 97 participants (Actual) | Interventional | 2010-09-30 | Completed |
| Randomized Control Trial Comparing Efficacy of Antibiotic Therapy Alone Versus Antibiotic Therapy in Conjunction With Quadruple Pulse Therapy Using NdYag Laser in Treatment of Hidradenitis Suppurativa[NCT01063270] | | 18 participants (Actual) | Interventional | 2010-02-28 | Completed |
| A Phase 1, Single Center, Randomized, Open-Label Study to Evaluate the Bioavailability of Clindamycin From Clindamycin 1%-Benzoyl Peroxide 3% Gel, Topical Gel (Clindamycin 1%- Benzoyl Peroxide 5%), and Once Daily Gel (Clindamycin 1%-Benzoyl Peroxide 5%) i[NCT01132443] | Phase 1 | 72 participants (Actual) | Interventional | 2010-05-06 | Completed |
| Preemptive Therapy Study of Cetuximab(Erbitux®)Induced Skin Rash Using Doxycycline, Sunscreen, Hydrocortisone and Moisturizer in Colorectal and Head and Neck Cancer Patients[NCT01874860] | Phase 2 | 24 participants (Actual) | Interventional | 2013-08-31 | Completed |
| A Randomized, Placebo-controlled, Evaluator-blinded, Study to Assess the Anti-inflammatory Effects of Topical Erythromycin and Clindamycin in Patients With Inflammatory Facial Acne[NCT03883269] | Phase 4 | 30 participants (Anticipated) | Interventional | 2018-03-20 | Recruiting |
| Randomized Noninferiority Study of an Antibacterial Envelope Alone Versus Envelope Plus Intraoperative Antibacterial Irrigant and Postoperative Antibiotics to Prevent Cardiac Implantable Electronic Device Infections in High-Risk Patients[NCT02809131] | Phase 3 | 1,010 participants (Actual) | Interventional | 2016-04-01 | Completed |
| The Efficacy of Laser Hair Removal Therapy in Patients With Mild to Moderate HS, a Randomized Controlled Trial.[NCT05762484] | | 58 participants (Anticipated) | Interventional | 2023-04-30 | Not yet recruiting |
| A Multi-center, Randomized, Single-blind, Paralelle, Positive Controlled Phase III Study to Evaluate the Efficacy and Safety of Adapalene-Clindamycin Combination Gel in the Treatment of Moderate Acne Vulgaris[NCT03615768] | Phase 3 | 1,617 participants (Actual) | Interventional | 2018-08-14 | Completed |
| Multicentre Evaluation of Fosmidomycin and Clindamycin in the Treatment of Acute Uncomplicated Plasmodium Falciparum Malaria in African Children[NCT01361269] | Phase 2 | 100 participants (Anticipated) | Interventional | 2011-06-30 | Not yet recruiting |
| Prospective Randomized Study to Compare Clinical Outcomes in Patients With Osteomyelitis Treated With Intravenous Antibiotics Versus Intravenous Antibiotics With an Early Switch to Oral Antibiotics[NCT02099240] | Early Phase 1 | 11 participants (Actual) | Interventional | 2014-03-06 | Terminated(stopped due to Not enough patient enrollment and lack of staffing) |
| A Randomized Clinical Trial to Measure the Impact of Retreatment With an Artemisinin-based Combination on Malaria Incidence and Its Potential Selection of Resistant Strains[NCT01374581] | Phase 3 | 2,117 participants (Actual) | Interventional | 2012-05-31 | Completed |
| A Double-blind, Placebo-controlled Multicenter Trial on the Effect of Clindamycin and a Live Biotherapeutic on the Reproductive Outcomes of IVF Patients With Abnormal Vaginal Microbiota[NCT05166746] | Phase 2 | 333 participants (Anticipated) | Interventional | 2017-12-07 | Recruiting |
| Effect of Gentamicin Versus Clindamycin Versus Normal Saline Lavage of the Axillary Surgical Bed After Lymph Node Dissection on Drainage Discharge Volume[NCT02314806] | Phase 3 | 51 participants (Actual) | Interventional | 2013-01-31 | Completed |
| Testing the Ability of a Microbiome - Focused Intervention to Reduce HIV Susceptibility in Ugandan Men[NCT03412071] | | 125 participants (Anticipated) | Interventional | 2017-12-07 | Recruiting |
| Randomized Controlled Research of the Application of Triple Antibiotic Paste in Primary Teeth With[NCT02196740] | | 100 participants (Anticipated) | Interventional | 2013-06-30 | Active, not recruiting |
| Oral Versus Intravenous Antibiotics for the Management of the Osteomyelitis of the Jaws: An Open-Label Non-Inferiority Single-Arm Clinical Trial[NCT05867654] | | 100 participants (Anticipated) | Observational | 2023-11-01 | Not yet recruiting |
| [NCT00694928] | Phase 3 | 843 participants (Actual) | Interventional | 2008-05-31 | Completed |
| Pilot for Vancomycin and Tobramycin Powder Use in Acute Open Fractures in the Emergency Department[NCT05849090] | Early Phase 1 | 50 participants (Anticipated) | Interventional | 2023-03-27 | Enrolling by invitation |
| Randomized, 2-Way Crossover, Bioequivalence Study of Clindamycin 300 mg Capsules and Cleocin Hcl Administered as 1 x 300 mg Capsule in Healthy Subjects Under Fed Conditions[NCT00836004] | Phase 1 | 24 participants (Actual) | Interventional | 2003-11-30 | Completed |
| A Randomized Clinical Trial Between Clindamycin Once and Thrice a Day in Septic Abortion.[NCT02309346] | Phase 4 | 190 participants (Anticipated) | Interventional | 2014-12-31 | Recruiting |
| Randomized, 2-Way Crossover, Bioequivalence Study of Clindamycin 300 mg Capsules and Cleocin HCl Administered as 1 x 300 mg Capsule in Healthy Subjects Under Fasting Conditions[NCT00836056] | Phase 1 | 24 participants (Actual) | Interventional | 2003-11-30 | Completed |
| [NCT00616330] | Phase 3 | 1,443 participants (Actual) | Interventional | 2008-01-31 | Completed |
| A Phase 3b, Comparative and Randomized Study to Assess the Efficacy and Safety of an Intravaginal Ovule Combination of Ketoconazole and Clindamycin Compared With an Intravaginal Cream Combination of Tetracycline and Amphotericin B for the Treatment of Bac[NCT01293643] | Phase 3 | 99 participants (Actual) | Interventional | 2010-05-31 | Completed |
| A Phase 4, Single-Blind, Randomized, Study to Compare the Tolerability and Efficacy of Tazorac Cream When Used in Combination With Either Duac Gel or Acanya Gel for the Treatment of Facial Acne Vulgaris[NCT01016977] | Phase 4 | 40 participants (Actual) | Interventional | 2009-10-31 | Completed |
| A Phase 3 Multi-Center, Double-Blind, Placebo-Controlled, Randomized Study of DARE-BV1 in the Treatment of Bacterial Vaginosis[NCT04370548] | Phase 3 | 307 participants (Actual) | Interventional | 2020-06-16 | Completed |
| Evaluation of Posterior Segment Intrusion Using Miniplates in Skeletal ClassII Hyperdivergent Adolescence: A Randomized Control Trial[NCT02674191] | | 24 participants (Actual) | Interventional | 2016-05-31 | Active, not recruiting |
| A Randomized Double Blind Multiple Center Placebo Controlled Study Comparing CLBG and Benzoyl Peroxide Gel 1%/5% to BenzaClin® (Clindamycin 1%/Benzoyl Peroxide 5%) Topical Gel in the Treatment of Acne Vulgaris[NCT02595034] | Phase 1 | 1,000 participants (Actual) | Interventional | 2015-01-31 | Completed |
| A Clinical Assessment of Combination Therapy With Differin® Gel, 0.3% With Duac® (Clindamycin/Benzoyl Peroxide Gel) in Subjects With Acne Vulgaris[NCT00671749] | Phase 4 | 100 participants (Actual) | Interventional | 2007-12-31 | Completed |
| A Randomized, Double-Blind, Multiple Center Placebo Controlled Study Comparing Taro Product to RLD and Both Treatments to a Placebo Control in the Treatment of Acne Vulgaris.[NCT04134273] | Phase 1 | 1,260 participants (Actual) | Interventional | 2019-03-20 | Completed |
| Comparative Efficacy and Safety of Benzoyl Peroxide Used in Combination With Clindamycin vs. Benzoyl Peroxide Used in Combination With Clindamycin and Doxycycline in the Treatment of Moderate Acne[NCT00837213] | Phase 4 | 33 participants (Actual) | Interventional | 2007-08-31 | Completed |
| A Single-blind, Randomized, Comparative Pilot Study Evaluating the Tolerability of Two Topical Combination Therapies in the Treatment of Acne Vulgaris[NCT00887484] | Phase 4 | 50 participants (Actual) | Interventional | 2009-02-28 | Completed |
| A Single-blind, Randomized, Comparative Split-face Study Evaluating the Tolerability of Clindamycin and Benzoyl Peroxide Gel to Benzoyl Peroxide/Adapalene Gel in the Treatment of Acne Vulgaris.[NCT00964223] | Phase 4 | 28 participants (Actual) | Interventional | 2009-07-31 | Completed |
| A Randomized, Controlled Trial of the Effectiveness of Perioperative Antibiotics for Reduction of Burn Wound Bacterial Concentration Following Grafting[NCT04516148] | Phase 4 | 32 participants (Actual) | Interventional | 2018-05-29 | Completed |
| Peritonsillar Abscess: Aspiration Versus Tonsillectomy a Chaud[NCT03326661] | | 128 participants (Anticipated) | Interventional | 2017-11-10 | Not yet recruiting |
| Effect of Peritoneal Lavage With Clindamycin-gentamicin Solution on Postoperative Pain and Analytic Acute Phase Reactants Following Laparoscopic Sleeve Gastrectomy[NCT02479971] | Phase 3 | 60 participants (Actual) | Interventional | 2014-01-31 | Completed |
| Comparative Effectiveness of Adjunctive Clindamycin Versus Linezolid for β-lactam Treated Patients With Invasive Group A Streptococcal Infections: A Target Trial Emulation[NCT06126263] | | 1,000 participants (Anticipated) | Observational | 2023-01-01 | Active, not recruiting |
| Clindamycin Versus Amoxicillin With Clavulanic Acid in Prevention of Early Dental Implants Failure[NCT04980170] | Early Phase 1 | 100 participants (Anticipated) | Interventional | 2021-11-01 | Not yet recruiting |
| Multicenter, Double-blind, Randomized, Parallel-group, Placebo-controlled Study to Evaluate the Bioequivalence of a Generic Clindamycin 1.2% and Benzoyl Peroxide 3.75% Gel to Onexton® Gel in Subjects With Acne Vulgaris[NCT02616614] | Phase 3 | 862 participants (Actual) | Interventional | 2015-05-31 | Completed |
| Rifampicin Combination Therapy Versus Targeted Antimicrobial Monotherapy in the Oral Antimicrobial Treatment Phase of Staphylococcal Prosthetic Joint Infection[NCT06172010] | Phase 4 | 316 participants (Anticipated) | Interventional | 2023-04-01 | Recruiting |
| Reducing INfection at the Surgical SitE With Antibiotic Irrigation During Ventral Hernia Repair (RINSE Trial)[NCT03945357] | Phase 3 | 250 participants (Actual) | Interventional | 2019-05-15 | Completed |
| Treatment of BV With First Deqularum and Then Direkt After With Vaginal Clindamycin Cream.[NCT04067531] | Phase 3 | 50 participants (Anticipated) | Interventional | 2020-08-01 | Recruiting |
| The Potential Impact of Clindamycin on Neurosurgery Patients.[NCT06068673] | | 44 participants (Anticipated) | Interventional | 2023-03-01 | Recruiting |
| A Phase 3 Multicenter, Randomized, Double-Blind, Active And Vehicle-Controlled Study Of The Safety And Efficacy Of CT Gel in Subjects With Acne Vulgaris[NCT00689117] | Phase 3 | 1,649 participants (Actual) | Interventional | 2008-04-30 | Completed |
| A Single Center Prospective Randomized Control Trial Investigating the Short-term and Long-term Effects of Intraoperative Prophylactic Antibiotics/Antiseptics on Surgical Outcomes in Chinese Post-mastectomy Breast Reconstruction Patients[NCT03742908] | | 291 participants (Anticipated) | Interventional | 2018-06-16 | Recruiting |
| A Randomized, Placebo Controlled Trial of the Effect of Prophylactic Antibiotics on Surgical Site Infection Lower Limb Skin Excisions[NCT03357419] | | 0 participants (Actual) | Interventional | 2021-03-31 | Withdrawn(stopped due to difficulties in production placebo antibiotics) |
| A Phase 3 Multicenter, Randomized, Double-Blind, Active And Vehicle-Controlled Study Of The Safety And Efficacy Of A Clindamycin / Benzoyl Peroxide Gel Versus Clindamycin Gel Versus Benzoyl Peroxide Gel Versus Vehicle Gel In Subjects With Acne Vulgaris[NCT00776919] | Phase 3 | 1,315 participants (Actual) | Interventional | 2008-10-31 | Completed |
| Randomized Multicenter Trial for the Prevention of Preterm Delivery by Testing for and Treatment of Bacterial Vaginosis in the First Trimester of Pregnancy[NCT00642980] | Phase 4 | 3,105 participants (Actual) | Interventional | 2006-04-30 | Completed |
| [NCT00664248] | Phase 3 | 1,414 participants (Actual) | Interventional | 2006-10-31 | Completed |
| The PROTECT Study: A Phase II, Open-Label Trial of PROphylactic Skin Toxicity ThErapy With Clindamycin and Triamcinolone in Glioblastoma Patients Treated With Tumor Treating Fields[NCT04469075] | Phase 2 | 58 participants (Anticipated) | Interventional | 2020-07-09 | Recruiting |
| A Double-Blind, Placebo-Controlled, Pilot Study to Determine the Safety and Efficacy of Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel For The Treatment of Rosacea Over 12 Weeks[NCT00823901] | Phase 2/Phase 3 | 83 participants (Actual) | Interventional | 2009-02-28 | Completed |
| A Phase 3, Multicenter, Randomized, Double-Blind Study To Evaluate The Safety And Efficacy Of Tigecycline Versus Comparator (Clindamycin Or Vancomycin) For The Treatment Of Complicated Skin And Skin Structure Infections, Including Those Due To MRSA, In Pe[NCT00911573] | Phase 3 | 0 participants (Actual) | Interventional | 2011-08-31 | Withdrawn |
| A Placebo Control, Multicenter, Randomized, Double Blind, Multi-formula Groups, and Parallel Phase Ⅰb+Ⅱa Study Evaluating the Safety and Efficacy of Compound Adapalene and Clindamycin Hydrochloride Gel in Treatment of Patients With Acne[NCT02593383] | Phase 1/Phase 2 | 245 participants (Actual) | Interventional | 2015-03-01 | Completed |
| Randomized, Double-Blind Trial of Clindamycin, Trimethoprim-Sulfamethoxazole, or Placebo for Uncomplicated Skin and Soft Tissue Infections Caused by Community-Associated Methicillin-Resistant Staphylococcus Aureus[NCT00730028] | Phase 2 | 1,310 participants (Actual) | Interventional | 2009-04-30 | Completed |
| Treatment of Chorioamnionitis After Delivery[NCT00814905] | | 300 participants (Anticipated) | Interventional | 2009-06-30 | Recruiting |
| Pharmacological Interaction of Rifampicin on Clindamycin in Staphylococcic Osteoarticular Infections[NCT02782078] | | 20 participants (Actual) | Interventional | 2017-03-06 | Completed |
| Effect of Irrigation With Antibiotic-containing Solutions Versus Sodium Hypochlorite on Postoperative Pain and Intra-canal Bacteria in Teeth With Necrotic Pulps (a Randomized Double-blind Clinical Trial)[NCT04035070] | Phase 4 | 51 participants (Anticipated) | Interventional | 2021-01-31 | Not yet recruiting |
| Two-week Study to Determine and Compare the Tolerance and Irritation Potential of Topical Antibiotic and Benzoyl Peroxide to Benzoyl Peroxide and Adapalene Topical Gel Acne Medications[NCT00926367] | Phase 4 | 52 participants (Actual) | Interventional | 2009-05-31 | Completed |
| Two-week Study to Determine and Compare the Tolerance and Irritation Potential of Duac® Topical Gel (Clindamycin 1% and Benzoyl Peroxide 5%) to ACANYA™ Gel (Clindamycin Phosphate 1.2% and Benzoyl Peroxide 2.5%) Topical Acne Medications[NCT01015638] | Phase 4 | 36 participants (Actual) | Interventional | 2009-08-31 | Completed |
| [NCT00663286] | Phase 3 | 1,399 participants (Actual) | Interventional | 2006-10-31 | Completed |
| A Multicenter, Randomized, Observer-Blinded, Active-Controlled Study to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of Ceftaroline Versus Comparator in Pediatric Subjects With Acute Bacterial Skin and Skin Structure Infections[NCT01400867] | Phase 2/Phase 3 | 163 participants (Actual) | Interventional | 2011-12-31 | Completed |
| A Multi-center, Randomized, Double-blind, Vehicle-Controlled, Phase 2 Study of the Safety and Efficacy of Benzoyl Peroxide/Clindamycin Gel and Tazarotene Cream When Used in Combination in the Treatment of Acne Vulgaris[NCT00713609] | Phase 2 | 591 participants (Actual) | Interventional | 2008-06-30 | Completed |
| Aspiration or Surgical Drainage of Perianal Abscess. A Randomized Controlled Clinical Study[NCT02585141] | | 111 participants (Actual) | Interventional | 2015-10-31 | Completed |
| A Multi Center Double Blind Randomized Placebo Controlled Parallel Group Study Comparing Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75% to Onexton™ Gel and Both Active Treatments to a Placebo Control in the Treatment of Acne Vulgaris[NCT02578043] | Phase 1 | 844 participants (Actual) | Interventional | 2015-04-30 | Completed |
| "Strategies Using Off-Patent Antibiotics for Methicillin-Resistant Staphylococcus Aureus (STOP MRSA) - A Phase IIB, Multi-Center, Randomized, Double-Blind Clinical Trial"[NCT00729937] | Phase 2/Phase 3 | 2,265 participants (Actual) | Interventional | 2009-04-30 | Completed |
| Laser Therapy for Perioral Dermatitis[NCT03779295] | | 0 participants (Actual) | Interventional | 2018-11-01 | Withdrawn(stopped due to No subjects enrolled.) |
| A Phase III Comparative Study of Dapsone / Trimethoprim and Clindamycin / Primaquine Versus Trimethoprim / Sulfamethoxazole in the Treatment of Mild-to-Moderate PCP in Patients With AIDS[NCT00000640] | Phase 3 | 290 participants | Interventional | | Completed |
| The Safety and Efficacy of Clindamycin and Primaquine in the Treatment of Mild - Moderate Pneumocystis Carinii Pneumonia in Patients With AIDS[NCT00000717] | | 50 participants | Interventional | | Completed |
| Phase III, Open Label, Randomized, Multicenter Study to Evaluate Efficacy, Tolerability & Safety of Combination of Clindamycin 100mg and Ketoconazole 400mg in Vaginal Capsules, Compared to Combination of Tetracycline 100mg and Amphotericin B 50mg in Vagin[NCT00889356] | Phase 3 | 160 participants (Anticipated) | Interventional | 2009-09-30 | Not yet recruiting |
| Comparison of Outcomes in Rhinoplasty With the Use of Intraoperative Versus Postoperative Antibiotics[NCT04194216] | Phase 3 | 864 participants (Anticipated) | Interventional | 2020-05-20 | Enrolling by invitation |
| The Pulsed Dye Laser as an Adjuvant Treatment Modality in Acne Vulgaris - a Randomized Controlled Single Blinded Trial[NCT01052246] | | 80 participants (Actual) | Interventional | 2008-10-31 | Completed |
| A Randomized Controlled Trial of Systemic and Topical Treatments for Rash Secondary to Erlotinib in Advanced Stage IIIB or IV Non-Small Cell Lung Cancer[NCT00473083] | Phase 2 | 150 participants (Actual) | Interventional | 2009-01-31 | Completed |
| A Single-Center, Evaluator-Blinded, Randomized, Placebo-Controlled, Phase 1 Clinical Trial Evaluating the Photoallergic Potential of Topically Applied Clindamycin Phosphate 1.0% and Tretinoin 0.025% (CT Gel) in Healthy Volunteers[NCT01915758] | Phase 1 | 64 participants (Actual) | Interventional | 2008-11-21 | Completed |
| Prophylactic Antibiotics for Manual Removal of Retained Placenta in Vaginal Birth[NCT01945450] | | 300 participants (Anticipated) | Interventional | 2014-01-31 | Not yet recruiting |
| A Comparative Assessment of the Efficacy of Fosmidomycin-Clindamycin Versus Sulfadoxine-Pyrimethamine for the Treatment of Children With Uncomplicated Plasmodium Falciparum Malaria[NCT00214643] | Phase 3 | 160 participants | Interventional | 2005-06-30 | Completed |
| A Randomized, Double-Blind, Multiple Center Placebo Controlled Study Comparing Taro Product to RLD and Both Treatments to a Placebo Control in the Treatment of Acne Vulgaris[NCT04321070] | Phase 1 | 550 participants (Actual) | Interventional | 2019-09-09 | Completed |
| CAT BITE Antibiotic Prophylaxis and Durations for the Hand/Forearm (CATBITE): A Prospective, Randomized, Placebo-controlled, Double-blinded, Clinical Trial[NCT05846399] | Phase 4 | 72 participants (Anticipated) | Interventional | 2023-09-07 | Recruiting |
| Role in Emergent Cerclage of Indomethacin and Antibiotics[NCT01114516] | | 53 participants (Actual) | Interventional | 2010-03-31 | Completed |
| Drug Use Evaluation Study of Clindamycin in Critical Care Units in Alexandria Main University Hospital[NCT05223400] | | 99 participants (Actual) | Observational | 2022-03-01 | Completed |
| Comparison of Safety and Efficacy of Tazarotene 0.1% Plus Clindamycin 1% Gel vs. Adapalene 0.1% Plus Clindamycin 1% Gel in the Treatment of Facial Acne Vulgaris: A Randomized Controlled Trial[NCT02721173] | Phase 4 | 60 participants (Actual) | Interventional | 2016-04-30 | Completed |
| Oral Corticosteroids Therapy and Interstitial Fibrosis in Patients With Pneumocystis Jirovecii Pneumonia (PCP) and pO2 of >70 at Presentation.[NCT00636935] | Phase 4 | 0 participants (Actual) | Interventional | 2008-02-29 | Withdrawn(stopped due to No patient completed protocol) |
| Adjunctive Clindamycin Versus Standard of Care for the Treatment of Skin and Soft Tissue Infections, a Randomized Controlled, Open-label Superiority Phase 4 Trial[NCT05899140] | Phase 4 | 100 participants (Anticipated) | Interventional | 2024-02-01 | Not yet recruiting |
| Pilot Study of Tolerability and Effectivity Following Application of Two Combination Topical Acne Products Clindamycin 1% and 0.025% Tretinoin Gel (Acnatac® Gel), Adapalen 0,1% and Benzoyl Peroxide 2,5% Gel (Epiduo® Gel)[NCT02731105] | Phase 4 | 22 participants (Actual) | Interventional | 2015-02-28 | Completed |
| Two-week Study to Determine and Compare the Tolerance and Irritation Potential of Clindamycin and Benzoyl Peroxide to Dapsone Gel Topical Acne Medications[NCT00964366] | Phase 4 | 53 participants (Actual) | Interventional | 2009-07-31 | Completed |
| A Pilot Study to Evaluate the Efficacy of Fixed Dose Combination Clindamycin Phosphate 1.2%/Tretinoin 0.025% Gel Alone Versus Fixed Dose Combination Clindamycin Phosphate 1.2%/Tretinoin 0.025% Gel Plus Benzoyl Peroxide 6% Foaming Cloths in the Treatment o[NCT01422785] | Phase 4 | 40 participants (Anticipated) | Interventional | 2011-07-31 | Recruiting |
| Oral vs Intravenous Antibiotics for Treatment of Periprosthetic Joint Infection[NCT04723940] | Phase 3 | 308 participants (Anticipated) | Interventional | 2021-01-25 | Enrolling by invitation |
| Antibiotics Usage in Pediatric Orthopaedic Percutaneous Surgery (APOPS)[NCT03261830] | Phase 4 | 168 participants (Actual) | Interventional | 2017-08-18 | Completed |
| Cutibacterium Acnes Persists Despite Topical Clindamycin and Benzoyl Peroxide[NCT03257202] | Phase 2 | 12 participants (Actual) | Interventional | 2017-09-11 | Completed |
| Toxoplasmic Encephalitis in Patients With AIDS. Treatment and Prevention of Relapse[NCT00002064] | | 0 participants | Interventional | | Completed |
| [NCT00372294] | Phase 3 | 0 participants | Interventional | 2005-07-31 | Active, not recruiting |
| Postoperative Antibiotic Requirements Following Immediate Breast Reconstruction[NCT01244698] | Phase 4 | 132 participants (Actual) | Interventional | 2010-11-30 | Completed |
| Management of Vaginal Complaints: A Pilot Study Within a Practice-Based Research Network[NCT00503542] | Early Phase 1 | 46 participants (Actual) | Interventional | 2007-02-28 | Completed |
| Antibiotics for Severe Perineal Laceration to Prevent Infection Following Repair[NCT04573504] | Phase 4 | 274 participants (Anticipated) | Interventional | 2020-09-23 | Recruiting |
| Phase IV Clinical Study Of Clindamycin Phosphate Topical Gel In The Treatment Of Acne Vulgaris[NCT00219570] | Phase 4 | 134 participants (Actual) | Interventional | 2005-01-31 | Completed |
| Prospective Randomized Evaluation of Antibiotic Regimen Following Appendectomy for Perforated Appendicitis[NCT00195923] | | 100 participants | Observational | 2005-04-30 | Completed |
| Evaluation of Fosmidomycin in Combination With Clindamycin in Children With Acute Uncomplicated Plasmodium Falciparum Malaria[NCT00217451] | Phase 2 | 51 participants | Interventional | 2002-06-30 | Completed |
| Comparison of the Efficacy of Clindamycin Phosphate 1% Gel Versus Once-daily Dapsone 5% Gel in the Treatment of Moderate Acne Vulgaris[NCT05926869] | Phase 2 | 100 participants (Actual) | Interventional | 2022-08-01 | Completed |
| A Pilot Study of Oral Clindamycin and Pyrimethamine for the Treatment of Toxoplasmic Encephalitis in Patients With AIDS[NCT00000674] | | 30 participants | Interventional | | Completed |
| [NCT00398658] | Phase 4 | 0 participants | Interventional | 2002-03-31 | Completed |
| A Phase 2, Open-Label, Randomized Trial Evaluating the Impact of Enhanced Versus Standard Dermatologic Management on Selected Dermatologic Adverse Events Among Patients With Locally Advanced or Metastatic EGFR-Mutated NSCLC Treated First-Line With Amivant[NCT06120140] | Phase 2 | 180 participants (Anticipated) | Interventional | 2024-03-08 | Not yet recruiting |
| Treatment of Methicillin-sensitive Staphylococcus Aureus Orthopaedic Infections With Clindamycin in Combination With Rifampin or Levofloxacin: a Randomized Pharmacological and Clinical Study (the CLINDOS Trial)[NCT01500837] | | 23 participants (Actual) | Interventional | 2010-10-31 | Completed |
| A Comparative Open Labeled Clinical Study to Evaluate the Efficacy and Tolerability of Two Different Intravaginal Formulations Containing a Combination of Clindamycin and Clotrimazole in Vaginal Infections[NCT01697826] | Phase 4 | 73 participants (Actual) | Interventional | 2011-04-30 | Completed |
| Comparing Post-drainage Treatment of Peritonsillar Abscesses With Antibiotics (Clavulin or Clindamycin) to Treating With Placebo - a Double-blinded Randomized Control Trial[NCT01715610] | | 0 participants (Actual) | Interventional | 2012-05-24 | Withdrawn(stopped due to unsuccessful recruitment) |
| A Multicenter, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study Comparing Taro Pharmaceutical Inc.'s Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% to the Reference Listed Acanya® (Clindamycin Phosphate and Benzoyl Peroxide)Ge[NCT01769235] | Phase 1 | 1,215 participants (Actual) | Interventional | 2012-11-30 | Completed |
| A Randomized, Double-Blind, Multiple-Site, Placebo-Controlled, Parallel Design Study Comparing Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel (Taro Pharmaceuticals Inc.) to Duac® Topical Gel Clindamycin 1%/Benzoyl Peroxide 5% (Stiefel) in the Treatment of[NCT01769664] | Phase 1 | 650 participants (Actual) | Interventional | 2012-09-30 | Completed |
| A Multicenter, Double-blind, Randomized, Vehicle-controlled, Parallel-group Study Comparing Clindamycin Phosphate and Benzoyl Peroxide Gel and Acanya® 1.2%/2.5% and Both Active Treatments to Vehicle Control for Treating Acne Vulgaris[NCT01788384] | Phase 3 | 708 participants (Actual) | Interventional | 2012-07-31 | Completed |
| Clindamycin to Reduce Preterm Birth in a Low Resource Setting: A Randomized Placebo-controlled Trial[NCT01800825] | Phase 4 | 1,726 participants (Actual) | Interventional | 2013-07-31 | Completed |
| Orthognathic Surgery and Postoperative Antibiotic Use[NCT01823523] | | 300 participants (Anticipated) | Interventional | 2013-06-30 | Recruiting |
| A Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study to Compare Perrigo Israel Pharmaceuticals, Ltd., Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel to a Comparator Clindamycin / Benzoyl Peroxide Topical Gel, and Both Active [NCT01138514] | Phase 3 | 1,555 participants (Actual) | Interventional | 2009-10-31 | Completed |
| [NCT02515305] | Phase 3 | 890 participants (Actual) | Interventional | 2015-07-31 | Completed |
| [NCT01231334] | Phase 4 | 286 participants (Actual) | Interventional | 2010-08-31 | Completed |
| Multicenter Pilot Study to Compare the Efficacy of a Combination of Vaginal Capsules With Acid Boric, L.Gasseri and L.Rhamnosus Versus the Reference Medication in Patients With Vaginal Candidiasis or Bacterial Vaginosis[NCT02860845] | Phase 4 | 48 participants (Actual) | Interventional | 2016-07-12 | Completed |
| Antibiotic Safety in Infants With Complicated Intra-Abdominal Infections (SCAMP Trial)[NCT01994993] | Phase 2/Phase 3 | 260 participants (Actual) | Interventional | 2013-12-31 | Completed |
| Safety and Pharmacokinetics of Multiple-Dose Intravenous and Oral Clindamycin in Pediatric Subjects With BMI ≥ 85th Percentile (NICHD): CLIN01[NCT01744730] | Phase 1 | 22 participants (Actual) | Interventional | 2013-06-30 | Completed |
| A Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study Comparing Clindamycin 1% Gel To Clindamycin 1% Gel (Greenstone LLC) and Both Active Treatments to Vehicle Control in the Treatment of Acne Vulgaris[NCT03522441] | Phase 3 | 1,125 participants (Actual) | Interventional | 2018-04-27 | Completed |
| Interventional Bioremediation of Microbiota in Metabolic Syndrome[NCT02730962] | Phase 2 | 12 participants (Actual) | Interventional | 2016-06-30 | Terminated(stopped due to Delays in IND approval caused a lack of funding to conduct the trial.) |
| A Pilot Study to Evaluate the Safety and Tolerability of CeraVe® Lotion Followed by Fixed Dose Clindamycin Phosphate 1.2% / Benzoyl Peroxide 2.5% Gel in the Morning in Combination With CeraVe® Lotion Followed by Tretinoin 0.05% Gel in the Evening for the [NCT01448733] | Phase 4 | 20 participants (Actual) | Interventional | 2011-07-31 | Active, not recruiting |
| DAICY Trial - Dual vs. Single-Antibiotic Impregnated Cement in Hemiarthroplasty for Femoral Neck Fracture: A Register-based Cluster-randomized Cross-over Controlled Trial[NCT05164081] | Phase 3 | 7,000 participants (Anticipated) | Interventional | 2022-01-01 | Recruiting |
| Evaluation of Fosmidomycin and Clindamycin in the Treatment of Acute Uncomplicated Plasmodium Falciparum Malaria in Children[NCT01464138] | Phase 2 | 52 participants (Actual) | Interventional | 2010-09-30 | Completed |
| A Single-Center, Evaluator-Blinded, Randomized, Placebo Controlled, Phase 1 Clinical Trial Evaluating The Phototoxic Potential Of Topically Applied Clindamycin 1.0% - Tretinoin 0.025% Gel (Ct Gel) In Healthy Volunteers[NCT01929278] | Phase 1 | 37 participants (Actual) | Interventional | 2008-12-08 | Completed |
| A Double Blind Randomised Control Trial to Measure the Effect of the Addition of Clindamycin to Flucloxacillin for the Treatment of Limb Cellulitis[NCT01876628] | Phase 4 | 410 participants (Actual) | Interventional | 2013-10-31 | Completed |
| A Randomized Placebo-controlled Double-blinded Trial of the Treatment of MRSA Throat Carriage With Either Standard Decolonization Therapy or Standard Decolonization Therapy Combined With Oral Clindamycin[NCT04104178] | Phase 3 | 80 participants (Anticipated) | Interventional | 2020-05-20 | Recruiting |
| Adherence to ZIANA (Clindamycin Phosphate 1.2% With Tretinoin 0.025%)Gel Compared to Generic Topical Clindamycin Plus Generic Topical Tretinoin in Subjects With Mild to Moderate Acne Vulgaris[NCT01047189] | Phase 4 | 26 participants (Actual) | Interventional | 2009-03-31 | Completed |
| Efficacy of Amoxicillin-metronidazole Compared to Clindamycin in the Treatment of Periodontitis in Patients With Diabetes[NCT03374176] | Phase 3 | 42 participants (Actual) | Interventional | 2014-03-31 | Completed |
| Comparison Between Oral Clindamycin Vs Metronidazole for the Treatment of Abnormal Vaginal Flora in High Risk Pregnancies[NCT01722708] | | 169 participants (Actual) | Interventional | 2012-04-30 | Completed |
| Antibiotic Prophylaxis for Prevention of Infection in Emergency Department Patients With Simple Hand Lacerations[NCT01155154] | | 73 participants (Actual) | Interventional | 2010-02-28 | Terminated |
| Randomized Controlled Trial of Antibiotics in the Management of Children With Community-Acquired Skin and Soft Tissue Abscess Undergoing Incision and Drainage[NCT01498744] | | 53 participants (Actual) | Interventional | 2010-02-28 | Terminated(stopped due to The study was closed due to poor enrollment and lack of interest.) |
| A Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study to Compare Perrigo Israel Pharmaceuticals, Ltd. Clindamycin Phosphate and Benzoyl Peroxide Topical Gel 1.2%/2.5% to Acanya® Topical Gel (Clindamycin Phosphate and Benzoyl P[NCT01796665] | Phase 3 | 1,180 participants (Actual) | Interventional | 2012-02-29 | Completed |
| Antibiotics During Intrauterine Balloon Tamponade Placement[NCT03478163] | Phase 4 | 11 participants (Actual) | Interventional | 2018-03-08 | Terminated(stopped due to Problems with recruitment) |
| Topical Clindamycin Salicylic Acid Preparation for the Treatment of Acne Vulgaris[NCT00361322] | Phase 1/Phase 2 | 40 participants | Interventional | 2005-04-30 | Completed |
| [NCT00377000] | Phase 4 | 60 participants | Interventional | 2005-11-30 | Completed |
| A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Comparison Study to Determine the Therapeutic Equivalence of GDC 268 and Clindamycin Phosphate Topical Lotion, 1% in Subjects With Acne Vulgaris[NCT03717506] | Phase 3 | 1,236 participants (Actual) | Interventional | 2018-10-10 | Completed |
| A Multi-centre, Single-blind, Parallel Group, Clinical Evaluation of the Efficacy and Safety of Clindamycin 1% / Benzoyl Peroxide 3% and Azelaic Acid 20% in the Topical Treatment of Mild to Moderate Acne Vulgaris[NCT02058628] | Phase 4 | 222 participants (Actual) | Interventional | 2014-02-21 | Completed |
| Asymptomatic Colonization With S. Aureus After Therapy With Linezolid or Clindamycin for Acute S. Aureus Skin and Skin Structure Infections in Patients With Comorbid Conditions: A Randomized Trial[NCT01619410] | | 25 participants (Actual) | Interventional | 2012-01-31 | Terminated(stopped due to slow accrual) |
| The Efficacy and Safety Study of Clindamycin Palmitate Hydrochloride Dispersible Tablet for the Treatment of Bacterial Vaginosis[NCT03080740] | Phase 4 | 300 participants (Anticipated) | Interventional | 2016-07-31 | Recruiting |
| Comparison of Cephalexin Versus Clindamycin in the Empiric, Outpatient Treatment of Suspected Staphylococcal Cutaneous Infections in the Era of Community-associated Methicillin-resistant Staphylococcus Aureus (CA-MRSA)[NCT00352612] | Phase 4 | 200 participants (Actual) | Interventional | 2006-09-30 | Completed |
| Effect of Preoperative Single-dose Clindamycin on Postoperative Endodontic Pain in Patients With Symptomatic Apical Periodontitis: A Randomized Controlled Trial[NCT03033472] | Phase 2/Phase 3 | 72 participants (Anticipated) | Interventional | | Not yet recruiting |
| A Multicentre, Randomized, Assessor-blind, Comparator-Controlled, Parallel-Group Clinical Trial to Establish the Efficacy and Safety of Duac™(1% Clindamycin as Clindamycin Phosphate and 5% Benzoyl Peroxide) Once Daily Gel Compared With Clindamycin Phospha[NCT01915732] | Phase 3 | 1,018 participants (Actual) | Interventional | 2013-04-30 | Completed |
| Clinical and Radiographic Effects of Modified Minimally Invasive Surgical Technique With Clindamycin Augmented Platelet-rich Fibrin Versus Platelet-rich Fibrin Alone for Management of Periodontal Intrabony Defects: A Randomized Controlled Clinical Trial[NCT05177198] | | 30 participants (Anticipated) | Interventional | 2022-03-31 | Not yet recruiting |
| Pharmacokinetics of Clindamycin and Trimethoprim-sulfamethoxazole in Infants and Children Using PBPK[NCT02475876] | Phase 1 | 51 participants (Actual) | Interventional | 2015-11-30 | Completed |
| A Randomized, Double-blind, Multicentric, Parallel-group, Active and Placebo Controlled, Three Arm Clinical Study to Compare the Efficacy and Safety of Clindamycin Phosphate 1.2% / Benzoyl Peroxide 5% Gel (of Cadila Healthcare Limited, India) Versus DUAC®[NCT02005666] | Phase 3 | 850 participants (Actual) | Interventional | 2013-11-30 | Completed |
| The Fleming [FMTVDM] Directed CoVid-19 Treatment Protocol[NCT04349410] | Phase 2/Phase 3 | 1,800 participants (Actual) | Interventional | 2020-04-11 | Completed |
| Factors Affecting Medication Adherence to Topical Acne Medications: a Single-center, Prospective Study Evaluating the Adherence and Patient Satisfaction to Single and Multiple Topical Acne Medications[NCT05582434] | Early Phase 1 | 72 participants (Anticipated) | Interventional | 2023-12-31 | Not yet recruiting |
| Determining the Necessity for Postoperative Antibiotics After Salivary Stent Placement[NCT03333408] | Phase 4 | 40 participants (Anticipated) | Interventional | 2018-06-15 | Recruiting |
| Utility of Single-dose Oral Antibiotic Prophylaxis in Prevention of Surgical Site Infection in Dermatologic Surgery[NCT04580472] | Phase 4 | 1,600 participants (Anticipated) | Interventional | 2020-10-01 | Recruiting |
| The Evaluation of Postoperative Antibiotics in Non-Infected Mandible Fractures[NCT04198129] | Phase 1 | 174 participants (Anticipated) | Interventional | 2020-10-01 | Recruiting |
| Treatment of Bacterial Vaginosis in Early Pregnancy in Skaraborg County in Sweden and the Effect on Spontaneous Preterm Delivery[NCT02348463] | | 540 participants (Actual) | Observational | 2007-01-31 | Completed |
| Antibiotic Irrigations for Intra-Abdominal Drains[NCT03476941] | Phase 2 | 50 participants (Anticipated) | Interventional | 2019-04-01 | Recruiting |
| Oral Antimicrobial Treatment vs. Outpatient Parenteral for Infective Endocarditis[NCT05398679] | Phase 4 | 360 participants (Anticipated) | Interventional | 2022-06-01 | Not yet recruiting |
| Continuous Versus Interrupted Use.of Vaginal Probiotic Plus Vaginal Clindamycin Cream for Bacterial Vaginosis a Randomized Controlled Study[NCT03234517] | Phase 2 | 200 participants (Anticipated) | Interventional | 2016-08-01 | Recruiting |
| A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multiple-Site Study to Evaluate the Therapeutic Equivalence of a Generic Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel (Glenmark Generics, Ltd) to the Marketed Product BenzaClin® Topical Gel[NCT02465632] | Phase 3 | 1,100 participants (Actual) | Interventional | 2015-04-30 | Completed |
| Efficacy, Safety and Tolerability of Amoxicillin + Clavulanic Acid (875mg/125mg) Two Times a Day Compared to Clindamycin (150mg) Four Times a Day for 5-7 Days in Treatment of Acute Odontogenic Infection With or Without Abscess[NCT02141217] | Phase 4 | 472 participants (Actual) | Interventional | 2013-03-21 | Completed |
| Postoperative Antibiotics Following Primary and Secondary Breast Augmentation: A Double-Blinded, Randomized Trial[NCT04834310] | Phase 4 | 0 participants (Actual) | Interventional | 2021-04-01 | Withdrawn(stopped due to Do not have adequate funding to proceed with project.) |
| [NCT02210689] | Phase 3 | 604 participants (Actual) | Interventional | 2014-01-31 | Completed |
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] |
Reduction of Inflammatory Lesions
The primary endpoint of the study was the mean percent reduction from baseline to week 11 in inflamed lesion count (papules and pustules). (NCT01044264)
Timeframe: Baseline and week 11
| Intervention | percentage reduction of lesions (Number) |
|---|
| 1% Clindamycin/5% Benzoyl Peroxide Topical Gel | 64.39 |
| DUAC® 1% Clindamycin/5% Benzoyl Peroxide Topical Gel | 63.10 |
| Placebo | 49.89 |
Number of Patients With a Major Cardiac Implantable Electronic Devices (CIED) Infection
The primary study endpoint will be the number of patients with CIED infection resulting in complete CIED system removal, antibiotic therapy in patients who are not candidates for system removal, or death due to CIED infection. (NCT02809131)
Timeframe: 6 months
| Intervention | Participants (Count of Participants) |
|---|
| Saline Irrigation | 5 |
| Antibiotic Irrigation and Oral Antibiotics | 6 |
Number of Patients With a Minor Cardiac Implantable Electronic Devices (CIED) Infection
A minor superficial infection of the incision that does not involve the generator pocket, does not result in any systemic symptoms or signs, and is treated with either observation or a short course of oral antibiotics (NCT02809131)
Timeframe: 6 months
| Intervention | Participants (Count of Participants) |
|---|
| Saline Irrigation | 5 |
| Antibiotic Irrigation and Oral Antibiotics | 5 |
AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)
Bioequivalence based on AUC0-t (NCT00836004)
Timeframe: Blood samples collected over 24 hour period
| Intervention | ng*h/mL (Mean) |
|---|
| Clindamycin | 14452.44 |
| Cleocin® | 14761.88 |
AUCinf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)
Bioequivalence based on AUCinf (NCT00836004)
Timeframe: Blood samples collected over 24 hour period
| Intervention | ng*h/mL (Mean) |
|---|
| Clindamycin | 14981.11 |
| Cleocin® | 15452.22 |
Cmax - Maximum Observed Concentration
Bioequivalence based on Cmax (NCT00836004)
Timeframe: Blood samples collected over 24 hour period
| Intervention | ng/mL (Mean) |
|---|
| Clindamycin | 2936.10 |
| Cleocin® | 2955.65 |
Bioequivalence Based on AUC0-t
AUC0-t - Area under the concentration-time curve from time zero to time of last non-zero concentration (NCT00836056)
Timeframe: Blood samples collected over 24 hour period
| Intervention | ng*h/mL (Mean) |
|---|
| Clindamycin | 10218.56 |
| Cleocin® | 10504.80 |
Bioequivalence Based on AUCinf
AUCinf - Area under the concentration-time curve from time zero to infinity (extrapolated) (NCT00836056)
Timeframe: Blood samples collected over 24 hour period
| Intervention | ng*h/mL (Mean) |
|---|
| Clindamycin | 10646.98 |
| Cleocin® | 10890.41 |
Bioequivalence Based on Cmax
Cmax - Maximum Observed Concentration (NCT00836056)
Timeframe: Blood samples collected over 24 hour period
| Intervention | ng/mL (Mean) |
|---|
| Clindamycin | 3008.88 |
| Cleocin® | 3086.02 |
Mean Change From Baseline for the Emotional Score of the Participant-completed Skindex-29 Quality of Life Questionnaire at Week 12
Skindex-29 is a 3-component (symptomatic, emotional, and functional) self-administered questionnaire (comprised of 30 questions) used to comprehensively measure the complex effects of skin diseases on a participant's quality of life. Participants were asked to answer questions based on a 5-point scale concerning their feelings over the past 4 weeks about the skin condition that has bothered them the most: 1, never; 2, rarely; 3, sometimes; 4, often; 5, all the time. The Emotional Score is the sum of 10 question scores; total score ranges from 10 to 50. (NCT01016977)
Timeframe: Baseline and Week 12
| Intervention | units on a scale (Mean) |
|---|
| Tazorac Cream/Duac Gel | -11.2 |
| Tazorac Cream/Acanya Gel | -7.1 |
Mean Change From Baseline for the Functional Score of the Participant-completed Skindex-29 Quality of Life Questionnaire at Week 12
Skindex-29 is a 3-component (symptomatic, emotional, and functional) self-administered questionnaire (comprised of 30 questions) used to comprehensively measure the complex effects of skin diseases on a participant's quality of life. Participants were asked to answer questions based on a 5-point scale concerning their feelings over the past 4 weeks about the skin condition that has bothered them the most: 1, never; 2, rarely; 3, sometimes; 4, often; 5, all the time. The Functional Score is the sum of 12 question scores; total score ranges from 12 to 60. (NCT01016977)
Timeframe: Baseline and Week 12
| Intervention | units on a scale (Mean) |
|---|
| Tazorac Cream/Duac Gel | -6.1 |
| Tazorac Cream/Acanya Gel | -3.7 |
Mean Change From Baseline for the Global Score of the Participant-completed Skindex-29 Quality of Life Questionnaire at Week 12
Skindex-29 is a 3-component (symptomatic, emotional, and functional) self-administered questionnaire (comprised of 30 questions) used to comprehensively measure the complex effects of skin diseases on a participant's quality of life. Participants were asked to answer questions based on a 5-point scale concerning their feelings over the past 4 weeks about the skin condition that has bothered them the most: 1, never; 2, rarely; 3, sometimes; 4, often; 5, all the time. The Global Score is the sum of the 30 question scores; total score ranges from 30 to 150. (NCT01016977)
Timeframe: Baseline and Week 12
| Intervention | units on a scale (Mean) |
|---|
| Tazorac Cream/Duac Gel | -6.1 |
| Tazorac Cream/Acanya Gel | -3.7 |
Mean Change From Baseline for the Symptomatic Score of the Participant-completed Skindex-29 Quality of Life Questionnaire at Week 12
Skindex-29 is a 3-component (symptomatic, emotional, and functional) self-administered questionnaire (comprised of 30 questions) used to comprehensively measure the complex effects of skin diseases on a participant's quality of life. Participants were asked to answer questions based on a 5-point scale concerning their feelings over the past 4 weeks about the skin condition that has bothered them the most: 1, never; 2, rarely; 3, sometimes; 4, often; 5, all the time. The Symptomatic Score is the sum of 7 question scores; total score ranges from 7 to 35. (NCT01016977)
Timeframe: Baseline and Week 12
| Intervention | units on a scale (Mean) |
|---|
| Tazorac Cream/Duac Gel | -8.7 |
| Tazorac Cream/Acanya Gel | -1.4 |
Number of Participants With at Least a Two-grade Improvement in ISGA Score From Baseline to Week 12
The investigator conducted the overall assessment of the participant's facial acne vulgaris based on the Investigator's Static Global Assessment Scale (ISGA). The ISGA is a 6-point scale: 0, clear skin with no acne vulgaris; 1, almost clear skin; 2, mild; 3, moderate; 4, severe; 5, very severe. (NCT01016977)
Timeframe: Baseline and Week 12
| Intervention | participants (Number) |
|---|
| Tazorac Cream/Duac Gel | 7 |
| Tazorac Cream/Acanya Gel | 10 |
Mean Change From Baseline in Burning/Stinging at Weeks 1, 2, 4, 8, and 12
Mean change from baseline was calculated as the average value at Weeks 1, 2, 4, 8, and 12 minus the value at baseline. Burning/stinging was assessed by participants based on a 6-point scale: 0=none: normal, no discomfort; 1=trace: awareness, no discomfort, no intervention required; 2=mild: noticeable discomfort, intermittent awareness; 3=moderate: noticeable discomfort, continuous awareness; 4=marked: definite discomfort, continuous awareness, interferes occasionally with normal daily activities; 5=severe: definite continuous discomfort, interferes with normal daily activities. (NCT01016977)
Timeframe: Baseline and Weeks 1, 2, 4, 8, and 12
| Intervention | units on a scale (Mean) |
|---|
| Week 1, n=19, 17 | Week 2, n=20, 19 | Week 4, n=20, 20 | Week 8, n=20, 20 | Week 12, n=20, 20 |
|---|
| Tazorac Cream/Acanya Gel | 1.65 | 0.84 | 0.55 | 0.45 | 0.40 |
,| Tazorac Cream/Duac Gel | 1.58 | 0.70 | 1.25 | 0.60 | 0.50 |
Mean Change From Baseline in Dryness at Weeks 1, 2, 4, 8, and 12
Mean change from baseline was calculated as the average value at Weeks 1, 2, 4, 8, and 12 minus the value at baseline. Dryness was assessed by the investigator based on a 6-point scale: 0=none, which is normal; 1=trace, which is mild and localized; 2=mild, which is mild and diffuse; 3=moderate, which is moderate and diffuse; 4=marked, which is moderate and dense; 5=severe, which is prominent and dense. (NCT01016977)
Timeframe: Baseline and Weeks 1, 2, 4, 8, and 12
| Intervention | units on a scale (Mean) |
|---|
| Week 1, n=19, 17 | Week 2, n=20, 19 | Week 4, n=20, 20 | Week 8, n=20, 20 | Week 12, n=20, 20 |
|---|
| Tazorac Cream/Acanya Gel | 1.18 | 0.84 | 0.55 | 0.15 | -0.05 |
,| Tazorac Cream/Duac Gel | 1.11 | 1.15 | 0.65 | 0.50 | 0.20 |
Mean Change From Baseline in Erythema at Weeks 1, 2, 4, 8, and 12
Mean change from baseline was calculated as the average value at Weeks 1, 2, 4, 8, and 12 minus the value at baseline. Erythema (redness of the skin, due to increased blood flow in the capillaries in the lower layers of theh skin) was assessed by the investigator based on a 6-point scale: 0=none, which is normal; 1=trace, which is mild and localized; 2=mild, which is mild and diffuse; 3=moderate, which is moderate and diffuse; 4=marked, which is moderate and dense; 5=severe, which is prominent and dense. (NCT01016977)
Timeframe: Baseline and Weeks 1, 2, 4, 8, and 12
| Intervention | units on a scale (Mean) |
|---|
| Week 1, n=19, 17 | Week 2, n=20, 19 | Week 4, n=20, 20 | Week 8, n=20, 20 | Week 12, n=20, 20 |
|---|
| Tazorac Cream/Acanya Gel | 0.76 | 0.47 | 0.55 | 0.20 | 0.10 |
,| Tazorac Cream/Duac Gel | 0.79 | 0.60 | 0.50 | 0.20 | 0.25 |
Mean Change From Baseline in Inflammatory and Non-inflammatory Lesion Counts at Weeks 1, 2, 4, 8, and 12
Inflammation is defined as a localized protective reaction of tissue to irritation, injury, or infection, characterized by pain, redness, swelling, and sometimes loss of function. The investigator counted inflammatory (papules, pustules, and nodules) and non-inflammatory (open and closed comedones) lesions on a participant's face at each study visit. The face is defined as the hairline edge to the mandibular line and should include the forehead, cheeks, and chin. W, Week. (NCT01016977)
Timeframe: Baseline and Weeks 1, 2, 4, 8, and 12
| Intervention | lesions (Mean) |
|---|
| W1, Inflammatory lesions, n=19, 17 | W2, Inflammatory lesions, n=20, 19 | W4, Inflammatory lesions, n=20, 20 | W8, Inflammatory lesions, n=20, 20 | W12, Inflammatory lesions, n=20, 20 | W1, Non-inflammatory lesions, n=19, 17 | W2, Non-inflammatory lesions, n=20, 19 | W4, Non-inflammatory lesions, n=20, 20 | W8, Non-inflammatory lesions, n=20, 20 | W12, Non-inflammatory lesions, n=20, 20 |
|---|
| Tazorac Cream/Acanya Gel | -5.9 | -8.1 | -9.6 | -16.3 | -13.4 | -7.6 | -15.1 | -26.6 | -33.1 | -37.8 |
,| Tazorac Cream/Duac Gel | -6.6 | -8.8 | -13.0 | -14.9 | -18.0 | -3.2 | -17.9 | -23.6 | -28.9 | -32.6 |
Mean Change From Baseline in Itching at Weeks 1, 2, 4, 8, and 12
Mean change from baseline was calculated as the average value at Weeks 1, 2, 4, 6, 8, and 12 minus the value at baseline. Itching was assessed by participants based on a 6-point scale: 0=none: normal, no discomfort; 1=trace: awareness, no discomfort, no intervention required; 2=mild: noticeable discomfort, intermittent awareness; 3=moderate: noticeable discomfort, continuous awareness; 4=marked: definite discomfort, continuous awareness, interferes occasionally with normal daily activities; 5=severe: definite continuous discomfort, interferes with normal daily activities. (NCT01016977)
Timeframe: Baseline and Weeks 1, 2, 4, 8, and 12
| Intervention | units on a scale (Mean) |
|---|
| Week 1, n=19, 17 | Week 2, n=20, 19 | Week 4, n=20, 20 | Week 8, n=20, 20 | Week 12, n=20, 20 |
|---|
| Tazorac Cream/Acanya Gel | 0.76 | 0.84 | 0.65 | 0.30 | 0.45 |
,| Tazorac Cream/Duac Gel | 0.68 | 0.10 | 0.20 | -0.05 | 0.35 |
Mean Change From Baseline in Oiliness at Weeks 1, 2, 4, 8, and 12
Mean change from baseline was calculated as the average value at Weeks 1, 2, 4, 8, and 12 minus the value at baseline. Oiliness was assessed by participants based on a 6-point scale: 0=none: normal, no discomfort; 1=trace: awareness, no discomfort, no intervention required; 2=mild: noticeable discomfort, intermittent awareness; 3=moderate: noticeable discomfort, continuous awareness; 4=marked: definite discomfort, continuous awareness, interferes occasionally with normal daily activities; 5=severe: definite continuous discomfort, interferes with normal daily activities. (NCT01016977)
Timeframe: Baseline and Weeks 1, 2, 4, 8, and 12
| Intervention | units on a scale (Mean) |
|---|
| Week 1, n=19, 17 | Week 2, n=20, 19 | Week 4, n=20, 20 | Week 8, n=20, 20 | Week 12, n=20, 20 |
|---|
| Tazorac Cream/Acanya Gel | -1.29 | -1.05 | -0.55 | -1.05 | -0.75 |
,| Tazorac Cream/Duac Gel | -1.00 | -0.95 | -0.85 | -0.80 | -0.35 |
Mean Change From Baseline in Peeling at Weeks 1, 2, 4, 8, and 12
Mean change from baseline was calculated as the average value at Weeks 1, 2, 4, 8, and 12 minus the value at baseline. Peeling was assessed by the investigator based on a 6-point scale: 0=none, which is normal; 1=trace, which is mild and localized; 2=mild, which is mild and diffuse; 3=moderate, which is moderate and diffuse; 4=marked, which is moderate and dense; 5=severe, which is prominent and dense. (NCT01016977)
Timeframe: Baseline and Weeks 1, 2, 4, 8, and 12
| Intervention | units on a scale (Mean) |
|---|
| Week 1, n=19, 17 | Week 2, n=20, 19 | Week 4, n=20, 20 | Week 8, n=20, 20 | Week 12, n=20, 20 |
|---|
| Tazorac Cream/Acanya Gel | 1.06 | 0.79 | 0.55 | 0.10 | -0.05 |
,| Tazorac Cream/Duac Gel | 1.11 | 1.05 | 0.60 | 0.50 | 0.20 |
Mean Change From Baseline in Skin Overall Comfort at Weeks 1, 2, 4, 8, and 12
Mean change from baseline was calculated as the average value at Weeks 1, 2, 4, 8, and 12 minus the value at baseline. Skin comfort was assessed by participants based on 5-point scale: +2, very comfortable; +1, comfortable; 0, neutral; -1, somewhat uncomfortable; or -2, uncomfortable. (NCT01016977)
Timeframe: Baseline and Weeks 1, 2, 4, 8, and 12
| Intervention | units on a scale (Mean) |
|---|
| Week 1, n=19, 17 | Week 2, n=20, 19 | Week 4, n=20, 20 | Week 8, n=20, 20 | Week 12, n=20, 20 |
|---|
| Tazorac Cream/Acanya Gel | -0.29 | 0.05 | -0.10 | 0.10 | 0.60 |
,| Tazorac Cream/Duac Gel | -0.37 | 0.25 | 0.05 | 0.30 | 0.45 |
Mean Change From Baseline in Total Lesion Count at Weeks 1, 2, 4, 8, and 12
The investigator will count inflammatory (papules, pustules, and nodules) and non-inflammatory (open and closed comedones) lesions on the participant's face at each study visit. The face is defined as the hairline edge to the mandibular line and should include the forehead, cheeks, and chin. (NCT01016977)
Timeframe: Baseline and Weeks 1, 2, 4, 8, and 12
| Intervention | lesions (Mean) |
|---|
| Week 1, n=19, 17 | Week 2, n=20, 19 | Week 4, n=20, 20 | Week 8, n=20, 20 | Week 12, n=20, 20 |
|---|
| Tazorac Cream/Acanya Gel | -13.5 | -23.1 | -36.2 | -49.4 | -51.1 |
,| Tazorac Cream/Duac Gel | -9.8 | -26.6 | -36.6 | -43.7 | -50.6 |
Overall Satisfaction With Study Product at Week 12
"Overall satisfaction with the study product was assessed from a participant's answer to the following question on the product acceptability and preference questionnaire at the end of study (i.e., Week 12): What is your overall satisfaction with the study product. Participants assessed overall satisfaction with the study product in the morning and evening, based on a 6-point scale: 1, very satisfied; 2, satisfied; 3, neutral (no opinion); 4, unsatisfied; 5, very unsatisfied." (NCT01016977)
Timeframe: Week 12
| Intervention | units on a scale (Mean) |
|---|
| Morning | Evening |
|---|
| Tazorac Cream/Acanya Gel | 1.75 | 1.70 |
,| Tazorac Cream/Duac Gel | 1.76 | 1.59 |
Number of Patients With Bacteriological Cure at Interim Assessment Visit, Day 7-14
(NCT04370548)
Timeframe: Visit 2, Days 7-14 post randomization
| Intervention | Participants (Count of Participants) |
|---|
| Clindamycin Phosphate Vaginal Gel, 2% | 50 |
| Placebo Vaginal Gel (Universal HEC Placebo Gel) | 2 |
Number of Patients With Bacteriological Cure at Test of Cure Visit, Days 21-30, PP Population
(NCT04370548)
Timeframe: Visit 3, Days 21-30 post randomization
| Intervention | Participants (Count of Participants) |
|---|
| Clindamycin Phosphate Vaginal Gel, 2% | 46 |
| Placebo Vaginal Gel (Universal HEC Placebo Gel) | 3 |
Number of Patients With Bacteriological Cure at the TOC Visit (Day 21-30).
Bacteriological cure is defined as a Nugent score < 4 (NCT04370548)
Timeframe: Visit 3 Day 21-30 post randomization
| Intervention | Participants (Count of Participants) |
|---|
| Clindamycin Phosphate Vaginal Gel, 2% | 53 |
| Placebo Vaginal Gel (Universal HEC Placebo Gel) | 3 |
Number of Patients With Bacteriological Cure, Interim Assessment Visit, Days 7-14, PP Population
(NCT04370548)
Timeframe: Visit 2, Days 7-14 post randomization
| Intervention | Participants (Count of Participants) |
|---|
| Clindamycin Phosphate Vaginal Gel, 2% | 45 |
| Placebo Vaginal Gel (Universal HEC Placebo Gel) | 1 |
Number of Patients With Clinical Cure at Interim Assessment Visit, Days 7-14, PP Population
(NCT04370548)
Timeframe: Visit 2, Days 7-14 post randomization
| Intervention | Participants (Count of Participants) |
|---|
| Clindamycin Phosphate Vaginal Gel, 2% | 83 |
| Placebo Vaginal Gel (Universal HEC Placebo Gel) | 14 |
Number of Patients With Clinical Cure at the Interim Assessment Visit (Day 7-14).
(NCT04370548)
Timeframe: Visit 2 Day 7-14 post randomization
| Intervention | Participants (Count of Participants) |
|---|
| Clindamycin Phosphate Vaginal Gel, 2% | 93 |
| Placebo Vaginal Gel (Universal HEC Placebo Gel) | 14 |
Number of Patients With Clinical Cure at the Test of Cure Visit (21-30)
(NCT04370548)
Timeframe: Visit 3, Days 21-30 post randomization
| Intervention | Participants (Count of Participants) |
|---|
| Clindamycin Phosphate Vaginal Gel, 2% | 79 |
| Placebo Vaginal Gel (Universal HEC Placebo Gel) | 20 |
Number of Patients With Clinical Cure at the TOC Visit (Day 21-30).
"Clinical cure is defined as:~Resolution of the abnormal vaginal discharge associated with BV;~Negative 10% KOH whiff test; and~Clue cells < 20% of the total epithelial cells in the saline wet mount." (NCT04370548)
Timeframe: Visit 3 Day 21-30 post randomization
| Intervention | Participants (Count of Participants) |
|---|
| Clindamycin Phosphate Vaginal Gel, 2% | 86 |
| Placebo Vaginal Gel (Universal HEC Placebo Gel) | 21 |
Number of Patients With Therapeutic Cure at Test of Cure Visit, Days 21-30; PP Population
(NCT04370548)
Timeframe: Visit 3, Days 21-30 post randomization
| Intervention | Participants (Count of Participants) |
|---|
| Clindamycin Phosphate Vaginal Gel, 2% | 41 |
| Placebo Vaginal Gel (Universal HEC Placebo Gel) | 3 |
Number of Patients With Therapeutic Cure at the Interim Assessment Visit (Day 7-14).
(NCT04370548)
Timeframe: Visit 2 Day 7-14 post randomization
| Intervention | Participants (Count of Participants) |
|---|
| Clindamycin Phosphate Vaginal Gel, 2% | 43 |
| Placebo Vaginal Gel (Universal HEC Placebo Gel) | 0 |
Number of Patients With Therapeutic Cure at the TOC Visit (Day 21-30).
(NCT04370548)
Timeframe: Visit 3 Day 21-30 post randomization
| Intervention | Participants (Count of Participants) |
|---|
| Clindamycin Phosphate Vaginal Gel, 2% | 45 |
| Placebo Vaginal Gel (Universal HEC Placebo Gel) | 3 |
Number of Patients With Therapeutic Cure, Interim Assessment Visit, Days 7-14, PP Population
(NCT04370548)
Timeframe: Visit 2, Days 7-14 post randomization
| Intervention | Participants (Count of Participants) |
|---|
| Clindamycin Phosphate Vaginal Gel, 2% | 39 |
| Placebo Vaginal Gel (Universal HEC Placebo Gel) | 0 |
Global Assessment of Improvement From Baseline
(NCT00671749)
Timeframe: 12 weeks
| Intervention | participants (Number) |
|---|
| Clear | Almost Clear | Marked Improvement | Moderate Improvement | Minimal Improvement | No Change | Worse |
|---|
| Combination Therapy | 3 | 40 | 27 | 16 | 5 | 8 | 1 |
Global Severity Assessment Success
Global Severity was assessed on a 6 point scale (Clear, Almost Clear, Mild, Moderate, Severe). The scale was dichotomized to success or failure where success = Clear or Almost Clear (NCT00671749)
Timeframe: 6 and 12 weeks
| Intervention | participants (Number) |
|---|
| Week 6 | Week 12 |
|---|
| Combination Therapy | 8 | 42 |
Percent Change From Baseline in Total Lesion Counts
(NCT00671749)
Timeframe: 6 and 12 weeks
| Intervention | Percent Change (Mean) |
|---|
| Week 6 | Week 12 |
|---|
| Combination Therapy | -47 | -64 |
Worst Post Baseline Tolerability Assessment - Burning/Stinging
"Please Note: Tolerability Assessments were captured separately from adverse events. Tolerability changes that required a dose modification or concomitant treatment were to be recorded on the Adverse Event CRF." (NCT00671749)
Timeframe: 12 weeks
| Intervention | participants (Number) |
|---|
| None | Mild | Moderate | Severe |
|---|
| Combination Therapy | 67 | 18 | 9 | 5 |
Worst Post Baseline Tolerability Assessment - Dryness
"Please Note: Tolerability Assessments were captured separately from adverse events. Tolerability changes that required a dose modification or concomitant treatment were to be recorded on the Adverse Event CRF." (NCT00671749)
Timeframe: 12 weeks
| Intervention | participants (Number) |
|---|
| None | Mild | Moderate | Severe |
|---|
| Combination Therapy | 49 | 27 | 20 | 3 |
Worst Post Baseline Tolerability Assessment - Erythema
"Please Note: Tolerability Assessments were captured separately from adverse events. Tolerability changes that required a dose modification or concomitant treatment were to be recorded on the Adverse Event CRF." (NCT00671749)
Timeframe: 12 weeks
| Intervention | participants (Number) |
|---|
| None | Mild | Moderate | Severe |
|---|
| Combination Therapy | 29 | 37 | 33 | 0 |
Worst Post Baseline Tolerability Assessment - Scaling
"Please Note: Tolerability Assessments were captured separately from adverse events. Tolerability changes that required a dose modification or concomitant treatment were to be recorded on the Adverse Event CRF." (NCT00671749)
Timeframe: 12 weeks
| Intervention | participants (Number) |
|---|
| None | Mild | Moderate | Severe |
|---|
| Combination Therapy | 53 | 27 | 16 | 3 |
Percent (%) Change in Inflammatory Lesion Counts (Chest and Back) From Baseline to Week 12
Percent change in inflammatory lesion counts (chest and back)from Baseline to Week 12 (NCT00837213)
Timeframe: Baseline, Week 12
| Intervention | Percent Change (Mean) |
|---|
| Benzoyl Peroxide Wash -Clindamycin Foam | -49.04 |
| Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules | -45.44 |
Percent (%) Change in Non-inflammatory Acne Lesions From Baseline to Week 16.
Percent change in Non-inflammatory acne lesions (whiteheads and blackheads)(chest and back) from baseline to week 16. (NCT00837213)
Timeframe: Baseline, Week 16
| Intervention | Percent Change (Mean) |
|---|
| Benzoyl Peroxide Wash -Clindamycin Foam | -25.27 |
| Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules | -44.69 |
Percent Change in Inflammatory Acne Lesions From Baseline to Week 16
Percent change from baseline to week 16 in inflammatory acne lesions (pustules/papules)(chest and back) (NCT00837213)
Timeframe: Baseline, Week 16
| Intervention | Percent change (Mean) |
|---|
| Benzoyl Peroxide Wash -Clindamycin Foam | -52.70 |
| Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules | -48.84 |
Percent Change in Non-inflammatory Lesions (Chest and Back) From Baseline to Week 12
Percent change in non-inflammatory lesions (chest and back) from baseline to Week 12 (NCT00837213)
Timeframe: Baseline, Week 12
| Intervention | Percent change (Mean) |
|---|
| Benzoyl Peroxide Wash -Clindamycin Foam | -38.43 |
| Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules | -38.52 |
Percent Change in Total Acne Lesion Counts From Baseline to Week 16
Percent change from baseline to week 16 in total acne lesions (inflammatory + non-inflammatory) (NCT00837213)
Timeframe: Baseline, Week 16
| Intervention | Percent Change (Mean) |
|---|
| Benzoyl Peroxide Wash -Clindamycin Foam | -38.49 |
| Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules | -46.11 |
Percent Change in Total Lesions (Chest and Back) From Baseline to Week 12
Percent change in total lesions (chest and back) from baseline to Week 12 (NCT00837213)
Timeframe: Week 12
| Intervention | Percent change (Mean) |
|---|
| Benzoyl Peroxide Wash -Clindamycin Foam | -44.16 |
| Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules | -41.74 |
Change in Investigator Global Assessment (IGA)
"Change in Investigator Global Assessment (IGA) Average values chest and back.~IGA scale:~0 - Clear~0.5 - Clear/almost clear~Almost Clear~1.5- Almost Clear/Mild~Mild~2.5- Mild/Moderate~Moderate~3.5- Moderate/Severe" (NCT00837213)
Timeframe: Baseline, Weeks 4, 8,12, and 16
| Intervention | Units on a scale (Mean) |
|---|
| Change from Baseline to Week 4 | Change from Baseline to Week 8 | Change from Baseline to Week 12 | Change from Baseline to Week 16 |
|---|
| Benzoyl Peroxide Wash -Clindamycin Foam | -0.42 | -0.55 | -1 | -0.9 |
,| Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules | -0.61 | -0.85 | -1.09 | -1.25 |
Percentage of Particpants With IGA Score at Week 16
"Investigator Global Assessment (IGA) at Week 16 based on the Investigator Global Assessment~IGA:~0 - Clear~0.5 - Clear/almost clear~Almost Clear~1.5- Almost Clear/Mild~Mild~2.5- Mild/Moderate~Moderate~3.5- Moderate/Severe" (NCT00837213)
Timeframe: Baseline, Week 16
| Intervention | Percent of participants (Number) |
|---|
| % Clear skin | % Clear or Almost Clear | % Almost Clear | % Almost clear/ mild | % Mild | % Mild/ Moderate | % Moderate |
|---|
| Benzoyl Peroxide Wash -Clindamycin Foam | 0 | 0 | 30 | 10 | 10 | 20 | 30 |
,| Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules | 8.3 | 8.3 | 25 | 8.3 | 25 | 8.3 | 16.7 |
Product Acceptability and Preference Questionnaire - Comfort of Skin at Week 8
Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 1, Very Comfortable; 2, Comfortable; 3, Somewhat Comfortable; 4, Somewhat Uncomfortable; 5, Uncomfortable. (NCT00887484)
Timeframe: Week 8
| Intervention | Units on a scale (Mean) |
|---|
| Clindoxyl Gel | 1.83 |
Product Acceptability and Preference Questionnaire - Comparison of Study Products Used in the Past at Week 8
Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, More Satisfied; 2, Somewhat More Satisfied; 3, Neither Satisfied or Dissatisfied; 4, Somewhat More Dissatisfied; 5, More Dissatisfied. (NCT00887484)
Timeframe: Week 8
| Intervention | Units on a scale (Mean) |
|---|
| Clindoxyl Gel | 1.63 |
Product Acceptability and Preference Questionnaire - Decrease of Acne Breakouts by Study Products at Week 8
Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, Highly Favorable; 2, Favorable; 3, Neutral; 4, Unfavorable; 5, More Dissatisfied. (NCT00887484)
Timeframe: Week 8
| Intervention | Units on a scale (Mean) |
|---|
| Clindoxyl Gel | 1.53 |
Product Acceptability and Preference Questionnaire - Ease of Application of Product at Week 8
Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, Very easy; 2, Easy; 3, Neutral; 4, Difficult. (NCT00887484)
Timeframe: Week 8
| Intervention | Units on a scale (Mean) |
|---|
| Clindoxyl Gel | 1.26 |
Product Acceptability and Preference Questionnaire - Ease of Use With Make-Up at Week 8
Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 0, Not Applicable; 1, Very Easy; 2, Easy; 3, Neutral; 4, Difficult; 5, Very Difficult. (NCT00887484)
Timeframe: Week 8
| Intervention | Units on a scale (Mean) |
|---|
| Clindoxyl Gel | 1.69 |
Product Acceptability and Preference Questionnaire - Overall Satisfaction of Study Product at Week 8
Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 1, Very Satisfied; 2, Satisfied; 3, Neutral; 4, Unsatisfied; 5, Very Unsatisfied. (NCT00887484)
Timeframe: Week 8
| Intervention | Units on a scale (Mean) |
|---|
| Clindoxyl Gel | 1.61 |
Product Acceptability and Preference Questionnaire - Severity of Burning at Week 8
Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe. (NCT00887484)
Timeframe: Week 8
| Intervention | Units on a scale (Mean) |
|---|
| Clindoxyl Gel | 0.36 |
Product Acceptability and Preference Questionnaire - Severity of Dryness at Week 8
Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe. (NCT00887484)
Timeframe: Week 8
| Intervention | Units on a scale (Mean) |
|---|
| Clindoxyl Gel | 0.64 |
Product Acceptability and Preference Questionnaire - Severity of Itching at Week 8
Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe. (NCT00887484)
Timeframe: Week 8
| Intervention | Units on a scale (Mean) |
|---|
| Clindoxyl Gel | 0.26 |
Product Acceptability and Preference Questionnaire - Severity of Redness at Week 8
Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe. (NCT00887484)
Timeframe: Week 8
| Intervention | Units on a scale (Mean) |
|---|
| Clindoxyl Gel | 0.77 |
Product Acceptability and Preference Questionnaire - Severity of Scaling at Week 8
Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe; 5, Very Severe. (NCT00887484)
Timeframe: Week 8
| Intervention | Units on a scale (Mean) |
|---|
| Clindoxyl Gel | 0.45 |
Erythema (Redness)
"Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face.~Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3, Intense." (NCT00887484)
Timeframe: Weeks 1 and 2
| Intervention | units on a scale (Mean) |
|---|
| Week 1 | Week 2 |
|---|
| Clindoxyl Gel | 0.66 | 0.55 |
,| Epiduo Gel | 0.91 | 0.74 |
Erythema (Redness)
"Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face.~Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3, Intense." (NCT00887484)
Timeframe: Weeks 5 and 8
| Intervention | units on a scale (Mean) |
|---|
| Week 5 | Week 8 |
|---|
| Clindoxyl Gel | 0.22 | 0.19 |
Inflammatory Acne Lesion Counts
Total number of inflammatory acne lesions (pustules, papules) at each timepoint. (NCT00887484)
Timeframe: Baseline, Weeks 5 and 8
| Intervention | Acne Lesions (Mean) |
|---|
| Baseline | Week 5 | Week 8 |
|---|
| Clindoxyl Gel | 14.23 | 4.60 | 4.26 |
Investigators Static Global Assessment
ISGA is evaluated using the following scale: 0, Clear: Clear skin with no lesions; 1, Almost Clear: Rare non-inflammatory lesions; 2, Mild: Some non-inflammatory lesions with no more than a few inflammatory lesions but no nodular lesions); 3, Moderate: Up to many non-inflammatory lesions and may have some inflammatory lesions, but no more than 1 small nodular lesion; 4, Severe: Up to many non-inflammatory and inflammatory lesions, but no more than a few nodular lesions; 5, Very Severe: Many non-inflammatory and inflammatory lesions and more than a few nodular lesions. May have cystic lesions. (NCT00887484)
Timeframe: Baseline, Weeks 5, 8
| Intervention | units on a scale (Mean) |
|---|
| Baseline | Week 5 | Week 8 |
|---|
| Clindoxyl Gel | 2.77 | 1.89 | 1.62 |
Non-inflammatory Acne Lesion Counts
Total number of non-inflammatory acne lesions (whiteheads and blackheads) at each timepoint. (NCT00887484)
Timeframe: Baseline, Weeks 5 and 8
| Intervention | Acne Lesions (Mean) |
|---|
| Baseline | Week 5 | Week 8 |
|---|
| Clindoxyl Gel | 24.83 | 11.36 | 9.51 |
Product Acceptability and Preference Questionnaire - Comfort of Skin at Weeks 1 and 2
Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 1, Very Comfortable; 2, Comfortable; 3, Somewhat Comfortable; 4, Somewhat Uncomfortable; 5, Uncomfortable. (NCT00887484)
Timeframe: Weeks 1 and 2
| Intervention | Units on a scale (Mean) |
|---|
| Week 1 | Week 2 |
|---|
| Clindoxyl Gel | 2.81 | 2.39 |
,| Epiduo Gel | 3.15 | 2.67 |
Product Acceptability and Preference Questionnaire - Compliance at Week 8
Product Acceptability and Preference Questionnaire were completed by the subject at week 8 by answering Yes or No to the following question: Did you use the product every day?. When only one product was applied to the face, subjects were asked to rate their compliance by answering the aforementioned question, rather than rating compliance on a 0-2 scale. (NCT00887484)
Timeframe: Week 8
| Intervention | Participants (Number) |
|---|
| Yes | No |
|---|
| Clindoxyl Gel | 43 | 3 |
Product Acceptability and Preference Questionnaire - Compliance at Weeks 1 and 2
Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 0, Not Compliant at all; 1, Mostly Compliant; 2, Very Compliant. (NCT00887484)
Timeframe: Weeks 1 and 2
| Intervention | Units on a scale (Mean) |
|---|
| Week 1 | Week 2 |
|---|
| Clindoxyl Gel | 1.91 | 1.85 |
,| Epiduo Gel | 1.91 | 1.85 |
Product Acceptability and Preference Questionnaire - Decrease of Acne Breakouts by Study Products at Weeks 1 and 2
Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 1, Highly Favorable; 2, Favorable; 3, Neutral; 4, Unfavorable; 5, Uncomfortable. (NCT00887484)
Timeframe: Weeks 1 and 2
| Intervention | Units on a scale (Mean) |
|---|
| Week 1 | Week 2 |
|---|
| Clindoxyl Gel | 1.87 | 1.85 |
,| Epiduo Gel | 2.04 | 2.00 |
Product Acceptability and Preference Questionnaire - Ease of Application of Product at Weeks 1 and 2
Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 1, Very easy; 2, Easy; 3, Neutral; 4, Difficult. (NCT00887484)
Timeframe: Weeks 1 and 2
| Intervention | Units on a scale (Mean) |
|---|
| Week 1 | Week 2 |
|---|
| Clindoxyl Gel | 1.30 | 1.35 |
,| Epiduo Gel | 1.32 | 1.39 |
Product Acceptability and Preference Questionnaire - Ease of Use Wtih Make-Up at Weeks 1 and 2
Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 0, Not Applicable; 1, Very Easy; 2, Easy; 3, Neutral; 4, Difficult; 5, Very Difficult. (NCT00887484)
Timeframe: Weeks 1 and 2
| Intervention | Units on a scale (Mean) |
|---|
| Week 1 | Week 2 |
|---|
| Clindoxyl Gel | 2.23 | 1.75 |
,| Epiduo Gel | 2.31 | 1.75 |
Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin at Week 8
Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint by answering Yes or No to the following question: Did you feel that your skin was hydrated and moisturized while you were on your study product? (NCT00887484)
Timeframe: Week 8
| Intervention | Participants (Number) |
|---|
| Yes | No |
|---|
| Clindoxyl Gel | 28 | 18 |
Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin at Weeks 1 and 2
Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint by answering Yes or No to the following question: Did you feel that your skin was hydrated and moisturized while you were on your study product? (NCT00887484)
Timeframe: Weeks 1 and 2
| Intervention | Participants (Number) |
|---|
| Week 1 - Yes | Week 1 - No | Week 2 - Yes | Week 2 - No |
|---|
| Clindoxyl Gel | 16 | 31 | 14 | 32 |
,| Epiduo Gel | 12 | 35 | 11 | 35 |
Product Acceptability and Preference Questionnaire - Overall Satisfaction of Study Product at Weeks 1 and 2
Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 1, Very Satisfied; 2, Satisfied; 3, Neutral; 4, Unsatisfied; 5, Very Unsatisfied. (NCT00887484)
Timeframe: Weeks 1 and 2
| Intervention | Units on a scale (Mean) |
|---|
| Week 1 | Week 2 |
|---|
| Clindoxyl Gel | 2.09 | 1.76 |
,| Epiduo Gel | 2.23 | 1.98 |
Product Acceptability and Preference Questionnaire - Severity of Burning at Weeks 1 and 2
Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe. (NCT00887484)
Timeframe: Weeks 1 and 2
| Intervention | Units on a scale (Mean) |
|---|
| Week 1 | Week 2 |
|---|
| Clindoxyl Gel | 0.91 | 0.72 |
,| Epiduo Gel | 1.68 | 1.30 |
Product Acceptability and Preference Questionnaire - Severity of Dryness at Weeks 1 and 2
Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe. (NCT00887484)
Timeframe: Weeks 1 and 2
| Intervention | Units on a scale (Mean) |
|---|
| Week 1 | Week 2 |
|---|
| Clindoxyl Gel | 1.30 | 1.00 |
,| Epiduo Gel | 1.81 | 1.41 |
Product Acceptability and Preference Questionnaire - Severity of Itching at Weeks 1 and 2
Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe. (NCT00887484)
Timeframe: Weeks 1 and 2
| Intervention | Units on a scale (Mean) |
|---|
| Week 1 | Week 2 |
|---|
| Clindoxyl Gel | 0.64 | 0.72 |
,| Epiduo Gel | 1.02 | 0.93 |
Product Acceptability and Preference Questionnaire - Severity of Redness at Weeks 1 and 2
Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe. (NCT00887484)
Timeframe: Weeks 1 and 2
| Intervention | Units on a scale (Mean) |
|---|
| Week 1 | Week 2 |
|---|
| Clindoxyl Gel | 1.09 | 0.72 |
,| Epiduo Gel | 1.72 | 1.15 |
Product Acceptability and Preference Questionnaire - Severity of Scaling at Weeks 1 and 2
Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe; 5, Very Severe. (NCT00887484)
Timeframe: Weeks 1 and 2
| Intervention | Units on a scale (Mean) |
|---|
| Week 1 | Week 2 |
|---|
| Clindoxyl Gel | 0.79 | 0.59 |
,| Epiduo Gel | 1.43 | 1.04 |
Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment at Week 1 and 2
Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint by answering Yes or No to the following question: If you were to choose to continue treatment for your acne, would you use the study product? (NCT00887484)
Timeframe: Weeks 1 and 2
| Intervention | Participants (Number) |
|---|
| Week 1 - Yes | Week 1 - No | Week 2 - Yes | Week 2 - No |
|---|
| Clindoxyl Gel | 44 | 3 | 39 | 7 |
,| Epiduo Gel | 26 | 21 | 32 | 14 |
Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment at Week 8
Product Acceptability and Preference Questionnaire were completed by the subject at 8 week timepoint by answering Yes or No to the following question: If you were to choose to continue treatment for your acne, would you use the study product? (NCT00887484)
Timeframe: Week 8
| Intervention | Participants (Number) |
|---|
| Yes | No |
|---|
| Clindoxyl Gel | 41 | 5 |
Product Acceptability and Preference Questionnaire - Which Study Product is Subject More Satisfied With? at Weeks 1 and 2
Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following choices: Epiduo, Clindoxyl Gel, Both Treatments Equally. (NCT00887484)
Timeframe: Weeks 1 and 2
| Intervention | Participants (Number) |
|---|
| Week 1, Epiduo Gel, n=47 | Week 1, Clindoxyl Gel, n=47 | Week 1, Both Treatments Equally, n=47 | Week 2, Epiduo Gel, n=46 | Week 2, Clindoxyl Gel, n=46 | Week 2, Both Treatments Equally, n=46 |
|---|
| All Subjects | 15 | 30 | 2 | 16 | 29 | 1 |
Quality of Life Questionnaire - Emotional Domain
Skindex-29 is a self-administered (by participants at each time point) QoL questionnaire comprised of 29 items (it.) scored on a 5-point scale (0=never, 1=rarely, 2=sometimes, 3=often, 4=all the time) covering 3 domains: emotional (10 it.); symptomatic (7 it.); functional (12 it.). Domain scores range from 0 to 40, 0 to 28, and 0 to 48, respectively. Lower scores=better QoL. The emotional score (score=0 to 40)=(sum of the 10 individual item scores) * 100/40. (NCT00887484)
Timeframe: Baseline, Weeks 2 and 8
| Intervention | Units on a scale (Mean) |
|---|
| Baseline | Week 2 | Week 8 |
|---|
| Clindoxyl Gel | 25.32 | 19.38 | 16.42 |
Quality of Life Questionnaire - Functional Domain
Skindex-29 is a self-administered (by participants at each time point) QoL questionnaire comprised of 29 items (it.) scored on a 5-point scale (0=never, 1=rarely, 2=sometimes, 3=often, 4=all the time) covering 3 domains: emotional (10 it.); symptomatic (7 it.); functional (12 it.). Domain scores range from 0 to 40, 0 to 28, and 0 to 48, respectively. Lower scores=better QoL. The functional score (score=0 to 48)=(sum of the 12 individual item scores) * 100/48. (NCT00887484)
Timeframe: Baseline, Weeks 2 and 8
| Intervention | Units on a scale (Mean) |
|---|
| Baseline | Week 2 | Week 8 |
|---|
| Clindoxyl Gel | 8.59 | 6.30 | 5.19 |
Quality of Life Questionnaire - Global Score
Skindex-29 is a self-administered (by participants at each time point) QoL questionnaire comprised of 29 items (it.) scored on a 5-point scale (0=never, 1=rarely, 2=sometimes, 3=often, 4=all the time) covering 3 domains: emotional (10 it.); symptomatic (7 it.); functional (12 it.). Domain scores range from 0 to 40, 0 to 28, and 0 to 48, respectively. Lower scores=better QoL. A Global Score (range 0-100)=(sum of all 29 individual item scores) * 100/116. (NCT00887484)
Timeframe: Baseline, Weeks 2 and 8
| Intervention | Units on a scale (Mean) |
|---|
| Baseline | Week 2 | Week 8 |
|---|
| Clindoxyl Gel | 8.59 | 6.30 | 5.19 |
Skin Dryness
"Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face.~Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3, Intense." (NCT00887484)
Timeframe: Weeks 1 and 2
| Intervention | units on a scale (Mean) |
|---|
| Week 1 | Week 2 |
|---|
| Clindoxyl Gel | 0.47 | 0.40 |
,| Epiduo Gel | 0.96 | 0.64 |
Skin Dryness
"Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face.~Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3, Intense." (NCT00887484)
Timeframe: Weeks 5 and 8
| Intervention | units on a scale (Mean) |
|---|
| Week 5 | Week 8 |
|---|
| Clindoxyl Gel | 0.20 | 0.04 |
Skin Peeling
"Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face.~Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3, Intense." (NCT00887484)
Timeframe: Weeks 5 and 8
| Intervention | units on a scale (Mean) |
|---|
| Week 5 | Week 8 |
|---|
| Clindoxyl Gel | 0.13 | 0.06 |
Skin Peeling
"Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face.~Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3,Intense." (NCT00887484)
Timeframe: Weeks 1 and 2
| Intervention | units on a scale (Mean) |
|---|
| Week 1 | Week 2 |
|---|
| Clindoxyl Gel | 0.34 | 0.40 |
,| Epiduo | 0.68 | 0.60 |
Skindex-29 Quality of Life Questionnaire (QoL) - Symptomatic Domain
Skindex-29 is a self-administered (by participants at each time point) QoL questionnaire comprised of 29 items (it.) scored on a 5-point scale (0=never, 1=rarely, 2=sometimes, 3=often, 4=all the time) covering 3 domains: emotional (10 it.); symptomatic (7 it.); functional (12 it.). Domain scores range from 0 to 40, 0 to 28, and 0 to 48, respectively. Lower scores=better QoL. The symptomatic score (score=0 to 28)=(sum of the 7 individual item scores) * 100/28. (NCT00887484)
Timeframe: Baseline, Weeks 2 and 8
| Intervention | Units on a scale (Mean) |
|---|
| Baseline | Week 2 | Week 8 |
|---|
| Clindoxyl Gel | 20.91 | 21.58 | 13.75 |
Total Acne Lesion Counts
Total acne lesion counts - includes both inflammatory acne lesions (pustules, papules), noninflammatory lesions (whiteheads and blackheads), (NCT00887484)
Timeframe: Baseline, Weeks 5 and 8
| Intervention | Acne Lesions (Mean) |
|---|
| Baseline | Week 5 | Week 8 |
|---|
| Clindoxyl Gel | 39.06 | 15.96 | 13.77 |
Product Acceptability and Preference Questionnaire - Comfort of Skin
Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, very comfortable; 2, comfortable; 3, somewhat comfortable; 4, somewhat uncomfortable; 5, uncomfortable. (NCT00964223)
Timeframe: Week 8
| Intervention | Units on a scale (Mean) |
|---|
| Duac Gel | 1.78 |
Product Acceptability and Preference Questionnaire - Comparison of Study Products to Products Used in the Past
Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, more satisfied; 2, somewhat more satisfied; 3, neither satisfied or dissatisfied; 4, more satisfied; 5, more dissatisfied. (NCT00964223)
Timeframe: Week 8
| Intervention | Units on a scale (Mean) |
|---|
| Duac Gel | 1.93 |
Product Acceptability and Preference Questionnaire - Decrease of Acne Breakouts by Study Products
Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, highly favorable; 2, favorable; 3, neutral; 4, unfavorable; 5, highly unfavorable. (NCT00964223)
Timeframe: Week 8
| Intervention | Units on a scale (Mean) |
|---|
| Duac Gel | 2.07 |
Product Acceptability and Preference Questionnaire - Ease of Application of Product
Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, very easy; 2, easy; 3, neutral; 4, difficult; 5, very difficult. (NCT00964223)
Timeframe: Week 8
| Intervention | Units on a scale (Mean) |
|---|
| Duac Gel | 1.26 |
Product Acceptability and Preference Questionnaire - Ease of Use With Make-Up
Measure Description Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, not applicable; 1, very easy; 2, easy; 3, neutral; 4, difficult. (NCT00964223)
Timeframe: Week 8
| Intervention | Units on a scale (Mean) |
|---|
| Duac Gel | 1.89 |
Product Acceptability and Preference Questionnaire - Overall Satisfaction of Study Product
Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, very satisfied; 2, satisfied; 3, neutral; 4, unsatisfied; 5, very unsatisfied. (NCT00964223)
Timeframe: Week 8
| Intervention | Units on a scale (Mean) |
|---|
| Duac Gel | 2.52 |
Product Acceptability and Preference Questionnaire - Severity of Burning
Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe. (NCT00964223)
Timeframe: Week 8
| Intervention | Units on a scale (Mean) |
|---|
| Duac Gel | 0.63 |
Product Acceptability and Preference Questionnaire - Severity of Dryness
Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe. (NCT00964223)
Timeframe: Week 8
| Intervention | Units on a scale (Mean) |
|---|
| Duac Gel | 1.22 |
Product Acceptability and Preference Questionnaire - Severity of Itching
Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe. (NCT00964223)
Timeframe: Week 8
| Intervention | Units on a scale (Mean) |
|---|
| Duac Gel | 0.63 |
Product Acceptability and Preference Questionnaire - Severity of Redness
Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe. (NCT00964223)
Timeframe: Week 8
| Intervention | Units on a scale (Mean) |
|---|
| Duac Gel | 1.00 |
Product Acceptability and Preference Questionnaire - Severity of Scaling
Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe. (NCT00964223)
Timeframe: Week 8
| Intervention | Units on a scale (Mean) |
|---|
| Duac Gel | 0.78 |
Erythema (Redness) Score
Investigator assessment of tolerability (erythema) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense. (NCT00964223)
Timeframe: Week 5, Week 8
| Intervention | Units on a scale (Mean) |
|---|
| Week 5 | Week 8 |
|---|
| Duac Gel | 0.26 | 0.19 |
Erythema (Redness) Score
Investigator assessment of tolerability (irritant/allergic contact dermatitis) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense. (NCT00964223)
Timeframe: Week 1, Week 2
| Intervention | Units on a scale (Mean) |
|---|
| Week 1 | Week 2 |
|---|
| Duac Gel | 0.27 | 0.18 |
,| Epiduo Gel | 0.58 | 0.36 |
Inflammatory Acne Lesion Counts
Total number of inflammatory acne lesions (pustules, papules) at each timepoint. (NCT00964223)
Timeframe: Week 5, Week 8
| Intervention | inflammatory acne lesions (Mean) |
|---|
| Week 5 | Week 8 |
|---|
| Duac Gel | 8.44 | 7.00 |
Investigator Static Global Assessment Score
ISGA is evaluated using the following scale: 0, clear, clear skin with no lesions; 1, almost clear, rare non-inflammatory lesions; 2, mild, some non-inflammatory lesions with no more than a few inflammatory lesions but no nodular lesions; 3, moderate, up to many non-inflammatory lesions and may have some inflammatory lesions, but no more than 1 small nodular lesion; 4, severe, up to many non-inflammatory and inflammatory lesions, but no more than a few nodular lesions; 5, very severe, many non-inflammatory and inflammatory lesions and more than a few nodular lesions. May have cystic lesions. (NCT00964223)
Timeframe: Week 5, Week 8
| Intervention | Units on a scale (Mean) |
|---|
| Week 5 | Week 8 |
|---|
| Duac Gel | 2.63 | 2.15 |
Non-Inflammatory Acne Lesion Counts
Total number of non-inflammatory acne lesions (whiteheads and blackheads) at each timepoint. (NCT00964223)
Timeframe: Week 5, Week 8
| Intervention | non-inflammatory acne lesions (Mean) |
|---|
| Week 5 | Week 8 |
|---|
| Duac Gel | 14.37 | 10.81 |
Product Acceptability and Preference Questionnaire - Comfort of Skin
Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 1, very comfortable; 2, comfortable; 3, somewhat comfortable; 4, somewhat uncomfortable; 5, uncomfortable. (NCT00964223)
Timeframe: Week 1, Week 2
| Intervention | Units on a scale (Mean) |
|---|
| Week 1 | Week 2 |
|---|
| Duac Gel | 2.38 | 2.00 |
,| Epiduo Gel | 2.58 | 2.25 |
Product Acceptability and Preference Questionnaire - Compliance
Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, non-compliant (< 50% of the week); 1, mostly compliant (50-79%); 2, very compliant (80-100%). (NCT00964223)
Timeframe: Week 1, Week 2
| Intervention | Units on a scale (Mean) |
|---|
| Week 1 | Week 2 |
|---|
| Duac Gel | 1.96 | 1.93 |
,| Epiduo Gel | 1.93 | 1.93 |
Product Acceptability and Preference Questionnaire - Compliance
Subject response to question regarding use of the product every day or not at week 8 time point answering Yes or No (NCT00964223)
Timeframe: Week 8
| Intervention | Participants (Number) |
|---|
| Yes | No |
|---|
| Duac Gel | 24 | 3 |
Product Acceptability and Preference Questionnaire - Decrease of Acne Breakouts by Study Products
Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 1, highly favorable; 2, favorable; 3, neutral; 4, unfavorable; 5, highly unfavorable. (NCT00964223)
Timeframe: Week 1, Week 2
| Intervention | Units on a scale (Mean) |
|---|
| Week 1 | Week 2 |
|---|
| Duac Gel | 2.27 | 2.14 |
,| Epiduo Gel | 2.27 | 2.07 |
Product Acceptability and Preference Questionnaire - Ease of Application of Product
Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 1, very easy; 2, easy; 3, neutral; 4, difficult; 5, very difficult. (NCT00964223)
Timeframe: Week 1, Week 2
| Intervention | Units on a scale (Mean) |
|---|
| Week 1 | Week 2 |
|---|
| Duac Gel | 1.46 | 1.43 |
,| Epiduo Gel | 1.50 | 1.50 |
Product Acceptability and Preference Questionnaire - Ease of Use With Make-Up
Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, not applicable; 1, very easy; 2, easy; 3, neutral; 4, difficult. (NCT00964223)
Timeframe: Week 1, Week 2
| Intervention | Units on a scale (Mean) |
|---|
| Week 1 | Week 2 |
|---|
| Duac Gel | 2.31 | 1.59 |
,| Epiduo Gel | 2.38 | 1.59 |
Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin
Subject response to question: did you feel that your skin was hydrated and moisturized while you on your study product? (Yes or No). (NCT00964223)
Timeframe: Week 1, Week 2
| Intervention | Participants (Number) |
|---|
| Week 1 - Yes | Week 1 - No | Week 2 - Yes | Week 2 - No |
|---|
| Duac Gel | 18 | 8 | 19 | 8 |
,| Epiduo Gel | 16 | 10 | 18 | 9 |
Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin
Subject response to question: did you feel that your skin was hydrated and moisturized while you on your study product? (Yes or No). (NCT00964223)
Timeframe: Week 8
| Intervention | Participants (Number) |
|---|
| Yes | No |
|---|
| Duac Gel | 24 | 3 |
Product Acceptability and Preference Questionnaire - Overall Satisfaction of Study Product
Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 1, very satisfied; 2, satisfied; 3, neutral; 4, unsatisfied; 5, very unsatisfied. (NCT00964223)
Timeframe: Week 1, Week 2
| Intervention | Units on a scale (Mean) |
|---|
| Week 1 | Week 2 |
|---|
| Duac Gel | 2.04 | 2.21 |
,| Epiduo Gel | 2.19 | 2.32 |
Product Acceptability and Preference Questionnaire - Severity of Burning
Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe. (NCT00964223)
Timeframe: Week 1, Week 2
| Intervention | Units on a scale (Mean) |
|---|
| Week 1 | Week 2 |
|---|
| Duac Gel | 1.12 | 0.73 |
,| Epiduo Gel | 1.96 | 1.11 |
Product Acceptability and Preference Questionnaire - Severity of Dryness
Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe. (NCT00964223)
Timeframe: Week 1, Week 2
| Intervention | Units on a scale (Mean) |
|---|
| Week 1 | Week 2 |
|---|
| Duac Gel | 1.42 | 1.31 |
,| Epiduo Gel | 1.88 | 1.58 |
Product Acceptability and Preference Questionnaire - Severity of Itching
Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe. (NCT00964223)
Timeframe: Week 1, Week 2
| Intervention | Units on a scale (Mean) |
|---|
| Week 1 | Week 2 |
|---|
| Duac Gel | 1.19 | 0.81 |
,| Epiduo Gel | 1.42 | 1.19 |
Product Acceptability and Preference Questionnaire - Severity of Redness
Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe. (NCT00964223)
Timeframe: Week 1, Week 2
| Intervention | Units on a scale (Mean) |
|---|
| Week 1 | Week 2 |
|---|
| Duac Gel | 1.12 | 0.78 |
,| Epiduo Gel | 1.54 | 1.00 |
Product Acceptability and Preference Questionnaire - Severity of Scaling
Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe. (NCT00964223)
Timeframe: Week 1, Week 2
| Intervention | Units on a scale (Mean) |
|---|
| Week 1 | Week 2 |
|---|
| Duac Gel | 0.77 | 0.69 |
,| Epiduo Gel | 1.15 | 1.00 |
Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment
Subject response to the following question: If you were to choose to continue treatment for your acne, which treatment would you choose? (Yes or No). (NCT00964223)
Timeframe: Week 1, Week 2
| Intervention | Participants (Number) |
|---|
| Week 1 - Yes | Week 1 - No | Week 2 - Yes | Week 2 - No |
|---|
| Duac Gel | 19 | 5 | 16 | 10 |
,| Epiduo Gel | 15 | 10 | 18 | 9 |
Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment
Subject response to the following question: If you were to choose to continue treatment for your acne, which treatment would you choose? (Yes or No). (NCT00964223)
Timeframe: Week 8
| Intervention | Participants (Number) |
|---|
| Yes | No |
|---|
| Duac Gel | 20 | 7 |
Product Acceptability and Preference Questionnaire - Which Study Product is Subject More Satisfied With?
Product Acceptability and Preference Questionnaire was completed by the subject at week 1 and week 2 asking which study product they were more satisfied with: Duac or Epiduo. (NCT00964223)
Timeframe: Week 1, Week 2
| Intervention | Participants (Number) |
|---|
| Week 1 | Week 2 |
|---|
| Duac Gel | 17 | 12 |
,| Epiduo Gel | 8 | 15 |
Skin Dryness Score
Investigator assessment of tolerability (skin dryness) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense. (NCT00964223)
Timeframe: Week 1, Week 2
| Intervention | Units on a scale (Mean) |
|---|
| Week 1 | Week 2 |
|---|
| Duac Gel | 0.15 | 0.14 |
,| Epiduo Gel | 0.46 | 0.29 |
Skin Dryness Score
Investigator assessment of tolerability (skin dryness) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense. (NCT00964223)
Timeframe: Week 5, Week 8
| Intervention | Units on a scale (Mean) |
|---|
| Week 5 | Week 8 |
|---|
| Duac Gel | 0.15 | 0.00 |
Skin Peeling Score
Investigator assessment of tolerability (skin peeling) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense. (NCT00964223)
Timeframe: Week 5, Week 8
| Intervention | Units on a scale (Mean) |
|---|
| Week 5 | Week 8 |
|---|
| Duac Gel | 0.00 | 0.00 |
Skin Peeling Score
Investigator assessment of tolerability (skin peeling) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; Intense, 3. (NCT00964223)
Timeframe: Week 1, Week 2
| Intervention | Units on a scale (Mean) |
|---|
| Week 1 | Week 2 |
|---|
| Duac Gel | 0.15 | 0.18 |
,| Epiduo Gel | 0.54 | 0.21 |
Skindex-29 Quality of Life Questionnaire - Emotional Domain
"Skindex-29 Quality of Life (QoL)Questionnaire used in dermatological disease consisting of 29 questions covering: burden of symptoms, functioning and emotional domains, with a five-point scale from: never to all the time, higher scores for each domain indicate worse effects on QoL. Scores range from 0 to 100. Higher scores indicate worse QoL for that domain." (NCT00964223)
Timeframe: Baseline, and Week 8
| Intervention | Units on a scale (Mean) |
|---|
| Baseline | Week 8 |
|---|
| Duac Gel | 44.29 | 35.37 |
Skindex-29 Quality of Life Questionnaire - Functional Domain
"Skindex-29 Quality of Life (QoL)Questionnaire used in dermatological disease consisting of 29 questions covering: burden of symptoms, functioning and emotional domains, with a five-point scale from: never to all the time, higher scores for each domain indicate worse effects on QoL. Scores range from 0 to 100. Higher scores indicate worse QoL for that domain." (NCT00964223)
Timeframe: Baseline, and Week 8
| Intervention | Units on a scale (Mean) |
|---|
| Baseline | Week 8 |
|---|
| Duac Gel | 14.06 | 9.10 |
Skindex-29 Quality of Life Questionnaire - Global Score
"Skindex-29 Quality of Life (QoL)Questionnaire used in dermatological disease consisting of 29 questions covering: burden of symptoms, functioning and emotional domains, with a five-point scale from: never to all the time, higher scores for each domain indicate worse effects on QoL. The Global Score ranges from 0 to 100. Higher scores indicate worse QoL for that domain." (NCT00964223)
Timeframe: Baseline, and Week 8
| Intervention | Units on a scale (Mean) |
|---|
| Baseline | Week 8 |
|---|
| Duac Gel | 14.06 | 9.10 |
Skindex-29 Quality of Life Questionnaire - Symptomatic Domain
"Skindex-29 Quality of Life (QoL) Questionnaire used in dermatological disease consisting of 29 questions covering: burden of symptoms, functioning and emotional domains, with a five-point scale from: never to all the time, higher scores for each domain indicate worse effects on QoL. Scores range from 0 to 100. Higher scores indicate worse QoL for that domain." (NCT00964223)
Timeframe: Baseline, and Week 8
| Intervention | Units on a scale (Mean) |
|---|
| Baseline | Week 8 |
|---|
| Duac Gel | 28.10 | 21.72 |
Total Acne Lesion Counts
Total acne lesion counts - includes both inflammatory acne lesions (pustules, papules), noninflammatory lesions (whiteheads and blackheads), (NCT00964223)
Timeframe: Week 5, Week 8
| Intervention | total acne lesions (Mean) |
|---|
| Week 5 | Week 8 |
|---|
| Duac Gel | 22.81 | 17.81 |
Percent Change in the Inflammatory (Papules and Pustules) Lesion Counts
Percent change from baseline to Week 12 (Day 84) in the inflammatory (papules and pustules) lesion count in PP Population. (NCT02616614)
Timeframe: 12 weeks
| Intervention | percentage of change (Mean) |
|---|
| Generic Clindamycin and Benzoyl Peroxide | -63.81 |
| Reference Onexton (Clindamycin and Benzoyl Peroxide) | -67.56 |
| Vehicle Gel | -53.78 |
Percent Change in the Non-Inflammatory (Open and Closed Comedomes) Lesion Counts
One of the co-primary endpoints was the percent change from baseline to Week 12 (Day 84) in the non-inflammatory (open and closed comedones) lesion counts in PP Population. (NCT02616614)
Timeframe: 12 weeks
| Intervention | percentage of change (Mean) |
|---|
| Generic Clindamycin and Benzoyl Peroxide | -49.58 |
| Reference Onexton (Clindamycin and Benzoyl Peroxide) | -49.50 |
| Vehicle Gel | -37.50 |
Number of Subjects With Treatment Success at Week 12
"The secondary efficacy endpoint was the IGA score, expressed in terms of proportion of subjects with treatment success or failure at Week 12, where success was defined as an IGA score that was at least 2 grades less than the baseline assessment." (NCT02616614)
Timeframe: 12 weeks
| Intervention | participants (Number) |
|---|
| Success | Failure |
|---|
| Generic Clindamycin and Benzoyl Peroxide | 54 | 199 |
,| Reference Onexton (Clindamycin and Benzoyl Peroxide) | 60 | 195 |
,| Vehicle Gel | 13 | 109 |
Incidence of SSI Requiring Intervention
Number of participants with SSI requiring reoperation or other procedural intervention at 30 days. (NCT03945357)
Timeframe: 30 days
| Intervention | Participants (Count of Participants) |
|---|
| Saline Irrigation | 8 |
| Antibiotic Irrigation | 8 |
Surgical Site Infection
Number of participants with Surgical Site Infections (NCT03945357)
Timeframe: 30 days
| Intervention | Participants (Count of Participants) |
|---|
| Saline Irrigation | 11 |
| Antibiotic Irrigation | 10 |
The Percentage of Participants Who Had a Minimum 2-grade Improvement in the Investigator's Static Global Assessment (ISGA) Score From Baseline to Week 12
"The ISGA is a static (snap-shot) evaluation of acne severity performed by an investigator/assessor at every visit. The ISGA score is measured on a 6-point ordinal scale, where 0=Clear and 5=Very Severe. Change is calculated as the Week 12 value minus the Baseline value." (NCT00689117)
Timeframe: Baseline, Week 12
| Intervention | percentage of participants (Number) |
|---|
| CT Gel | 36.3 |
| Clindamycin Gel | 26.6 |
| Tretinoin Gel | 26.1 |
| Vehicle Gel | 20.2 |
The Percentage of Participants Who Had ISGA Scores of 0 or 1 at Week 12
"The ISGA is a static (snap-shot) evaluation of acne severity performed by an investigator/assessor at every visit. The ISGA score is measured on a 6-point ordinal scale, where 0=Clear and 5=Very Severe. A score of 1=Skin Almost Clear: rare non-inflammatory lesions present, with rare non-inflamed papules (papules must be resolving and may be hyper-pigmented, though not pink-red) requiring no futher treatment in the Investigator's opinion." (NCT00689117)
Timeframe: Week 12
| Intervention | percentage of participants (Number) |
|---|
| CT Gel | 43.1 |
| Clindamycin Gel | 36.6 |
| Tretinoin Gel | 33.8 |
| Vehicle Gel | 22.7 |
The Percentage of Participants With a Subjects Global Assessment Score of 0 or 1 at Week 12
The SGA score is a global evaluation of acne severity performed by participants at all visits and measured on a 5-point ordinal scale, where 0=My face is basically free of acne and 5=My face has blackheads and/or whiteheads. A score of 1=My face has several blackheads and/or whiteheads and small pimples, but there are no tender deep-seated bumps or cysts. (NCT00689117)
Timeframe: Week 12
| Intervention | participants (Number) |
|---|
| CT Gel | 62 |
| Clindamycin Gel | 60 |
| Tretinoin Gel | 62 |
| Vehicle Gel | 50 |
Absolute Change From Baseline in Lesion Counts (Total, Inflammatory, and Non-inflammatory) at Week 12 (End of Study)
Acne lesion counts (inflammatory [papules, pustules, nodules], non-inflammatory [open and closed comedones], and total) were performed on the face of participants. Change from baseline is defined as Week 12 values minus Baseline values. The total lesion count is the sum of the inflammatory and non-inflammatory lesion counts. (NCT00689117)
Timeframe: Baseline, Week 12
| Intervention | lesions (Mean) |
|---|
| Inflammatory Lesion Counts | Non-Inflammatory Lesion Counts | Total Lesion Counts |
|---|
| Clindamycin Gel | -14.5 | -19.5 | -34.0 |
,| CT Gel | -15.5 | -23.2 | -38.7 |
,| Tretinoin Gel | -13.9 | -22.1 | -36.0 |
,| Vehicle Gel | -11.1 | -17.0 | -28.1 |
Percent Change From Baseline in Lesion Counts (Inflammatory, Non-inflammatory, and Total) at Week 12
Acne lesion counts (inflammatory [papules, pustules, nodules], non-inflammatory [open and closed comedones], and total) were performed on the face of participants. Change from baseline is defined as Week 12 values minus Baseline values. The total lesion count is the sum of the inflammatory and non-inflammatory lesion counts. (NCT00689117)
Timeframe: Baseline, Week 12
| Intervention | percent change (Mean) |
|---|
| Inflammatory Lesions | Non-Inflammatory Lesions | Total Lesions |
|---|
| Clindamycin Gel | -56.6 | -42.9 | -49.0 |
,| CT Gel | -60.5 | -51.1 | -55.0 |
,| Tretinoin Gel | -54.5 | -47.3 | -50.6 |
,| Vehicle Gel | -43.3 | -36.0 | -39.1 |
Mean Change From Baseline (BL) to Week 12 in Inflammatory Lesion Counts
During each study visit, trained study personnel at every investigational center assessed the inflammatory (pustules [small inflamed elevation of the skin that is filled with pus], papules [solid elevation of skin with no visible fluid], nodules [larger than papules with significant depth]) lesion counts for each participant. Each type of lesion was counted separately, and counts were taken from the face (including forehead, nose, cheeks, and chin). Missing values were imputed using the last observation carried forward (LOCF) method. (NCT00776919)
Timeframe: Baseline (Day 1) and Week 12
| Intervention | lesion counts (Mean) |
|---|
| Duac Low-dose (LD) Gel | -18.2 |
| Clindamycin Gel | -15.6 |
| BPO Gel | -16.8 |
| Vehicle Gel | -13.1 |
Mean Change From Baseline to Week 12 in Non-inflammatory Lesion Counts
During each study visit, trained study personnel at every investigational center assessed the non-inflammatory (open comedones [blackheads] and closed comedones [whiteheads]) lesion counts for each participant. Each type of lesion was counted separately, and counts were taken from the face (including forehead, nose, cheeks, and chin). (NCT00776919)
Timeframe: Baseline (Day 1) and Week 12
| Intervention | lesion counts (Mean) |
|---|
| Duac Low-dose (LD) Gel | -24.8 |
| Clindamycin Gel | -19.8 |
| BPO Gel | -22.2 |
| Vehicle Gel | -14.8 |
Mean Change From Baseline to Week 12 in Pulse Rate
Pulse rate was measured at Baseline and Week 12 (end of study). Mean change from Baseline was calculated as the mean value at Week 12 minus the mean value at Baseline. (NCT00776919)
Timeframe: Baseline (Day 1) and Week 12
| Intervention | Beats per minute (bpm) (Mean) |
|---|
| Duac Low-dose (LD) Gel | 1 |
| Clindamycin Gel | 2 |
| BPO Gel | 2 |
| Vehicle Gel | 2 |
Mean Change From Baseline to Week 12 in Temperature
Temperature was measured at Baseline and Week 12 (end of study). Mean change from Baseline was calculated as the mean value at Week 12 minus the mean value at Baseline. (NCT00776919)
Timeframe: Baseline (Day 1) and Week 12
| Intervention | Degrees centigrade (Mean) |
|---|
| Duac Low-dose (LD) Gel | -0.1 |
| Clindamycin Gel | 0.0 |
| BPO Gel | 0.0 |
| Vehicle Gel | 0.0 |
Mean Change From Baseline to Week 12 in Total Lesion Counts
During each study visit, trained study personnel at every investigational center assessed the inflammatory (pustules, papules, nodules) and non-inflammatory (open and closed comedones) lesion counts for each participant. Each type of lesion was counted separately; the lesion counts were taken from the face (including forehead, nose, cheeks, and chin). Total lesion counts were calculated as the sum of the inflammatory and non-inflammatory lesion counts. (NCT00776919)
Timeframe: Baseline (Day 1) and Week 12
| Intervention | lesion counts (Mean) |
|---|
| Duac Low-dose (LD) Gel | -43.0 |
| Clindamycin Gel | -35.5 |
| BPO Gel | -39.0 |
| Vehicle Gel | -27.8 |
Mean Duration of Study Product Use
Mean duration of study product use was calculated as the average total duration inclusive of missed applications of the study product. (NCT00776919)
Timeframe: Baseline (Day 1) through Week 12
| Intervention | days (Mean) |
|---|
| Duac Low-dose (LD) Gel | 79.5 |
| Clindamycin Gel | 78.0 |
| BPO Gel | 78.0 |
| Vehicle Gel | 77.8 |
Number of Participants Who Had a Subject Global Assessment (SGA) Score of 0 or 1 at Week 12
During each study visit, participants evaluated their facial acne (excluding the scalp) using the SGA scale: 0=free of acne, with only an occasional blackhead/whitehead; 1=several blackheads/whiteheads and small pimples, no tender deep-seated bumps/cysts; 2=several to many blackheads/whiteheads and small to medium-sized pimples, one deep-seated bump/cyst; 3=many blackheads/whiteheads, many medium- to large-sized pimples, few deep-seated bumps/cysts; 4=presence of blackheads/whiteheads, several to many medium- to large-sized pimples, deep-seated bumps/cysts dominate. (NCT00776919)
Timeframe: Week 12
| Intervention | participants (Number) |
|---|
| Duac Low-dose (LD) Gel | 209 |
| Clindamycin Gel | 171 |
| BPO Gel | 189 |
| Vehicle Gel | 154 |
Number of Participants Who Had an ISGA Score of 0 or 1 at Week 12
During each study visit, investigators/assessors evaluated the acne severity of participants' faces using the ISGA scal: 0=clear skin with no lesions (L); 1=almost clear, rare non-inflammatory L; 2=mild, some non-inflammatory L with no more than a few inflammatory L, no nodular L; 3=moderate, many non-inflammatory L, may have some inflammatory L, but no more than 1 small nodular L; 4=severe, many non-inflammatory and inflammatory L, but no more than a few nodular L; 5=very severe, many non-inflammatory and inflammatory L, and more than a few nodular L. (NCT00776919)
Timeframe: Week 12
| Intervention | participants (Number) |
|---|
| Duac Low-dose (LD) Gel | 148 |
| Clindamycin Gel | 91 |
| BPO Gel | 116 |
| Vehicle Gel | 81 |
Number of Participants With Improvement of at Least 2 Grades in the Investigator's Static Global Assessment (ISGA) Score From Baseline to Week 12
During each study visit, investigators/assessors evaluated acne severity of the participants' faces using the ISGA scale: 0=clear skin with no lesions (L); 1=almost clear, rare non-inflammatory L; 2=mild, some non-inflammatory L with no more than a few inflammatory L, no nodular L; 3=moderate, many non-inflammatory L, may have some inflammatory L, but no more than 1 small nodular L; 4=severe, many non-inflammatory and inflammatory L, but no more than a few nodular L; 5=very severe, many non-inflammatory and inflammatory L, and more than a few nodular L. (NCT00776919)
Timeframe: Baseline (Day 1) and Week 12
| Intervention | participants (Number) |
|---|
| Duac Low-dose (LD) Gel | 129 |
| Clindamycin Gel | 82 |
| BPO Gel | 100 |
| Vehicle Gel | 59 |
Mean Change From Baseline to Week 12 in Systolic and Diastolic Blood Pressure
Systolic and diastolic blood pressure were measured at Baseline and Week 12 (end of study). Mean change from Baseline was calculated as the mean value at Week 12 minus the mean value at Baseline. (NCT00776919)
Timeframe: Baseline (Day 1) and Week 12
| Intervention | Millimeters of mercury (mmHg) (Mean) |
|---|
| Systolic blood pressure | Diastolic blood pressure |
|---|
| BPO Gel | 0 | 0 |
,| Clindamycin Gel | 0 | 1 |
,| Duac Low-dose (LD) Gel | 0 | 0 |
,| Vehicle Gel | 0 | 0 |
Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Erythema, Dryness, and Peeling
Erythema (Er, redness), dryness (Dr), and peeling (Pn), were evaluated independently by the investigator as: 0 (absent)=no Er, Dr, or Pn; 1 (slight)=faint red/pink coloration (col.), barely perceptible Dr with no flakes or fissure, mild localized Pn; 2 (mild)=light red/pink col., perceptible Dr with no flakes/fissure, mild and diffuse Pn; 3 (moderate)=medium red col., easily noted Dr and flakes but no fissure; 4 (severe)=beet red col., Dr with flakes and fissure, prominent dense Pn. Change from Baseline was calculated as the value at Weeks 2, 4, 8, and 12 minus the the value at Baseline. (NCT00776919)
Timeframe: Baseline; Weeks 2, 4, 8, and 12
| Intervention | scores on a scale (Mean) |
|---|
| Erythema, Week 2, n=298, 302, 306, 306 | Erythema, Week 4, n=298, 300, 299, 306 | Erythema, Week 8, n=297, 296, 294, 293 | Erythema, Week 12, n=297, 296, 296, 294 | Dryness, Week 2, n=298, 302, 306, 306 | Dryness, Week 4, n=298, 300, 299, 306 | Dryness, Week 8, n=297, 296, 294, 293 | Dryness, Week 12, n=297, 296, 296, 294 | Peeling, Week 2, n=298, 302, 306, 306 | Peeling, Week 4, n=298, 300, 299, 306 | Peeling, Week 8, n=297, 296, 294, 293 | Peeling, Week 12, n=297, 296, 296, 294 |
|---|
| BPO Gel | -0.07 | -0.08 | -0.15 | -0.17 | 0.09 | 0.08 | 0.05 | -0.01 | 0.08 | 0.01 | -0.01 | -0.02 |
,| Clindamycin Gel | -0.01 | -0.07 | -0.08 | -0.18 | 0.03 | -0.02 | -0.02 | -0.10 | 0.02 | 0.00 | -0.01 | -0.06 |
,| Duac Low-dose (LD) Gel | -0.05 | -0.07 | -0.12 | -0.17 | 0.07 | 0.05 | 0.00 | -0.07 | 0.03 | -0.01 | -0.01 | -0.08 |
,| Vehicle Gel | -0.02 | -0.06 | -0.08 | -0.13 | 0.04 | 0.00 | 0.02 | -0.04 | 0.02 | 0.00 | 0.00 | -0.04 |
Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Itching and Burning/Stinging
Itching and burning/stinging (piercing pain) were evaluated independently by the investigator as: 0 (none)=normal, no discomfort; 1 (slight)=noticeable discomfort that caused intermittent awareness; 2 (moderate)=noticeable discomfort that caused intermittent awareness and interfered occasionally with normal daily activities; 3 (strong)=definite continuous discomfort that interfered with normal daily activities. Change from Baseline was calculated as the value at Weeks 2, 4, 8, and 12 minus the value at Baseline. (NCT00776919)
Timeframe: Baseline; Weeks 2, 4, 8, and 12
| Intervention | scores on a scale (Mean) |
|---|
| Itching, Week 2, n=297, 301, 305, 305 | Itching, Week 4, n=298, 299, 299, 305 | Itching, Week 8, n=297, 295, 293, 291 | Itching, Week 12, n=297, 295, 294, 293 | Burning/Stinging, Week 2, n=297, 301, 305, 305 | Burning/Stinging, Week 4, n=298, 2991, 299, 305 | Burning/Stinging, Week 8, n=297, 295, 293, 291 | Burning/Stinging, Week 12, n=297, 295, 294, 293 |
|---|
| BPO Gel | -0.04 | -0.07 | -0.08 | -0.13 | -0.02 | -0.05 | -0.05 | -0.04 |
,| Clindamycin Gel | -0.18 | -0.18 | -0.24 | -0.28 | -0.06 | -0.09 | -0.09 | -0.13 |
,| Duac Low-dose (LD) Gel | -0.11 | -0.11 | -0.16 | -0.21 | 0.02 | -0.06 | -0.05 | -0.09 |
,| Vehicle Gel | -0.06 | -0.10 | -0.08 | -0.13 | -0.05 | -0.02 | -0.06 | -0.04 |
Mean Percent Change From Baseline to Week 12 in Lesion Counts (Total, Inflammatory, and Non-inflammatory)
During each study visit, trained study personnel at every investigational center assessed the inflammatory (pustules, papules, nodules) and non-inflammatory (open and closed comedones) lesion counts for each participant. Each type of lesion was counted separately; the lesion counts were taken from the face (including forehead, nose, cheeks, and chin). Total lesion counts were calculated as the sum of the inflammatory and non-inflammatory lesion counts. Percent change from Baseline to Week 12 was calculated as the value at Week 12 minus the value at Baseline divided by the Baseline value * 100. (NCT00776919)
Timeframe: Baseline (Day 1) and Week 12
| Intervention | Percent change in lesion counts (Mean) |
|---|
| Inflammatory Lesions | Non-inflammatory Lesions | Total Lesions |
|---|
| BPO Gel | -61.8 | -50.8 | -55.5 |
,| Clindamycin Gel | -58.1 | -43.3 | -49.2 |
,| Duac Low-dose (LD) Gel | -68.9 | -53.9 | -59.8 |
,| Vehicle Gel | -48.8 | -34.0 | -40.4 |
Number of Participants Reporting the Indicated Treatment-emergent Adverse Events (AEs) Resulting in Study Product Discontinuation
An AE included, but was not limited to, any clinically significant worsening of a pre-existing condition; an event occurring from overdose (i.e., a dose higher than that indicated in the protocol) of the study product, whether accidental or intentional; an event occurring from abuse (e.g., use for nonstudy reasons) of the study product; or an event that was associated with the discontinuation of the use of the study product. (NCT00776919)
Timeframe: Baseline (Day 1) through Week 12
| Intervention | participants (Number) |
|---|
| Application Site Dermatitis | Application Site Hypersensitivity | Application Site Pruritus | Varicella |
|---|
| BPO Gel | 0 | 1 | 1 | 0 |
,| Clindamycin Gel | 0 | 0 | 0 | 0 |
,| Duac Low-dose (LD) Gel | 1 | 0 | 0 | 0 |
,| Vehicle Gel | 0 | 0 | 1 | 1 |
Mean Change in Number of Inflammatory Lesions From Baseline to Week 12
The number of inflammatory lesions (papules and pustules) on the face were counted by a dermatologist at baseline and week 12 for each participant. Change in the number of inflammatory lesions is defined as week 12 values minus the baseline values of the participant. Last observation carried forward (LOCF) method was used for missing values. (NCT00823901)
Timeframe: Baseline, week 12
| Intervention | lesions (Mean) |
|---|
| Clindamycin/Tretinoin Gel | .83 |
| Placebo | -3.13 |
Number of Participants Reporting Adverse Events That Are Treatment Limiting.
Participants were issued a Memory Aid to record symptoms for 10 days post product administration. At study visits, the staff reviewed the memory aid and elicited as much information as possible about any reported symptoms. Occurrence of adverse events was solicited in the memory aid and during study visits. Reported symptoms, both solicited and unsolicited, were recorded as Adverse Events. For these results, adverse events that resulted in discontinuation of study treatment for the participant were considered treatment limiting. (NCT00730028)
Timeframe: End of Treatment (EOT) (48 hours after completion of therapy); Test of Cure (TOC) (7-10 days after completion of therapy); One Month Follow-up Visit (OMFU)
| Intervention | participants (Number) |
|---|
| Cellulitis or Larger Abscess - Clindamycin | 1 |
| Cellulitis or Larger Abscess - TMP-SMX | 0 |
| Limited Abscess - Clindamycin | 6 |
| Limited Abscess - TMP-SMX | 3 |
| Limited Abscess - Placebo | 4 |
Number of Participants Reporting Adverse Events.
Subjects were issued a Memory Aid to record symptoms for 10 days post product administration. At study visits, the staff reviewed the memory aid and elicited as much information as possible about any reported symptoms. Occurrence of adverse events was solicited in the memory aid and during study visits. Reported symptoms, both solicited and unsolicited, were recorded as Adverse Events. (NCT00730028)
Timeframe: End of Treatment (EOT) (48 hours after completion of therapy); Test of Cure (TOC) (7-10 days after completion of therapy); One Month Follow-up Visit (OMFU)
| Intervention | participants (Number) |
|---|
| Cellulitis or Larger Abscess - Clindamycin | 116 |
| Cellulitis or Larger Abscess - TMP-SMX | 132 |
| Limited Abscess - Clindamycin | 119 |
| Limited Abscess - TMP-SMX | 94 |
| Limited Abscess - Placebo | 119 |
Percentage of Participants Achieving Clinical Cure at the End of Treatment (EOT) Visit for the Evaluable Population.
Measures of clinical cure and clinical failure are the same as those defined for the primary efficacy outcome measure. (NCT00730028)
Timeframe: EOT visit within 48 hours of completion of therapy
| Intervention | percentage of participants (Number) |
|---|
| Cellulitis or Larger Abscess - Clindamycin | 89.2 |
| Cellulitis or Larger Abscess - TMP-SMX | 88.3 |
| Limited Abscess - Clindamycin | 90.9 |
| Limited Abscess - TMP-SMX | 94.2 |
| Limited Abscess - Placebo | 84.9 |
Percentage of Participants Achieving Clinical Cure at the End of Treatment (EOT) Visit for the Intent-to-Treat (ITT) Population.
Measures of clinical cure and clinical failure are the same as those defined for the primary efficacy outcome measure. (NCT00730028)
Timeframe: EOT visit within 48 hours of completion of therapy
| Intervention | percentage of participants (Number) |
|---|
| Cellulitis or Larger Abscess - Clindamycin | 81.1 |
| Cellulitis or Larger Abscess - TMP-SMX | 75.4 |
| Limited Abscess - Clindamycin | 78.9 |
| Limited Abscess - TMP-SMX | 79.8 |
| Limited Abscess - Placebo | 72.4 |
Percentage of Participants Achieving Clinical Cure at the One Month Follow-up (OMFU) Visit for the Evaluable Population.
Measures of clinical cure and clinical failure are the same as those defined for the primary efficacy outcome measure, with one addition. At the OMFU, relapse (the return of the original infection after initial improvement) or recurrence (return of skin infection at original site after cure of original infection) of SSTI was scored as clinical failure. (NCT00730028)
Timeframe: OMFU visit
| Intervention | percentage of participants (Number) |
|---|
| Cellulitis or Larger Abscess - Clindamycin | 83.9 |
| Cellulitis or Larger Abscess - TMP-SMX | 78.2 |
| Limited Abscess - Clindamycin | 89.3 |
| Limited Abscess - TMP-SMX | 85.0 |
| Limited Abscess - Placebo | 73.9 |
Percentage of Participants Achieving Clinical Cure at the One Month Follow-up (OMFU) Visit for the Intent-to-Treat (ITT) Population.
Measures of clinical cure and clinical failure are the same as those defined for the primary efficacy outcome measure, with one addition. At the OMFU, relapse (the return of the original infection after initial improvement) or recurrence (return of skin infection at original site after cure of original infection) of SSTI was scored as clinical failure. (NCT00730028)
Timeframe: OMFU visit
| Intervention | percentage of participants (Number) |
|---|
| Cellulitis or Larger Abscess - Clindamycin | 73.1 |
| Cellulitis or Larger Abscess - TMP-SMX | 67.7 |
| Limited Abscess - Clindamycin | 78.6 |
| Limited Abscess - TMP-SMX | 73.0 |
| Limited Abscess - Placebo | 62.6 |
Percentage of Participants Achieving Clinical Cure, Defined as Absence of Clinical Failure, in the Evaluable Population.
"Clinical failure is defined as the occurence of any of the following:~Lack of resolution at the Test of Cure (TOC) visit in any or all of the following: erythema, tenderness, purulent drainage, swelling, and local warmth. Erythema or tenderness that was considered due the surgical therapy itself (incision and drainage), was not considered to be indicative of clinical failure.~Occurrence of a SSTI at another site other than the site(s) under study.~Intolerance of study medication or a treatment-limiting adverse reaction necessitating discontinuation of study drug within the first 48 hours.~Administration of other antimicrobial therapy for treatment of a SSTI at any time through the TOC visit.~Unplanned surgical procedure for the infection under study at any time through the TOC visit.~Hospitalization for treatment of active or invasive infection at any time through the TOC visit." (NCT00730028)
Timeframe: Test of cure (TOC) (7-10 days after completion of therapy)
| Intervention | percentage of participants (Number) |
|---|
| Cellulitis or Larger Abscess - Clindamycin | 89.5 |
| Cellulitis or Larger Abscess - TMP-SMX | 88.2 |
| Limited Abscess - Clindamycin | 92.9 |
| Limited Abscess - TMP-SMX | 92.7 |
| Limited Abscess - Placebo | 80.5 |
Percentage of Participants Achieving Clinical Cure, Defined as Absence of Clinical Failure, in the Intent-to-Treat (ITT) Population.
"Clinical failure is defined as the occurence of any of the following:~Lack of resolution at the Test of Cure (TOC) visit in any or all of the following: erythema, tenderness, purulent drainage, swelling, and local warmth. Erythema or tenderness that was considered due the surgical therapy itself (incision and drainage), was not considered to be indicative of clinical failure.~Occurrence of a SSTI at another site other than the site(s) under study.~Intolerance of study medication or a treatment-limiting adverse reaction necessitating discontinuation of study drug within the first 48 hours.~Administration of other antimicrobial therapy for treatment of a SSTI at any time through the TOC visit.~Unplanned surgical procedure for the infection under study at any time through the TOC visit.~Hospitalization for treatment of active or invasive infection at any time through the TOC visit." (NCT00730028)
Timeframe: Test of cure (TOC) (7-10 days after completion of therapy)
| Intervention | percentage of participants (Number) |
|---|
| Cellulitis or Larger Abscess - Clindamycin | 80.3 |
| Cellulitis or Larger Abscess - TMP-SMX | 77.7 |
| Limited Abscess - Clindamycin | 83.1 |
| Limited Abscess - TMP-SMX | 81.7 |
| Limited Abscess - Placebo | 68.9 |
Product Acceptability and Preference Questionnaire - Did You Feel That Your Skin Was Hydrated and Moisturized While You Were on Your Study Product?
"The subject were presented with a questionnaire at day 14 (end of study) and was asked the following question: Did you feel that your skin was hydrated and moisturized while you were on your study product?~The subject replied using the following scale:~1 - Yes 0 - No" (NCT00926367)
Timeframe: Day 14
| Intervention | units on a scale (Mean) |
|---|
| Duac | 0.58 |
| Epiduo | 0.54 |
Product Acceptability and Preference Questionnaire - How Compliant Were You With Applying the Study Product Each and Every Day?
"The subject were presented with a questionnaire at day 14 (end of study) and was asked the following question: How compliant were you with applying the study product each and every day?~The subject replied using the following scale:~0 - Not Compliant at all (<50%)~- Mostly Compliant (50%-79%)~- Very Compliant (80%-100%)" (NCT00926367)
Timeframe: Day 14
| Intervention | units on a scale (Mean) |
|---|
| Duac | 2.00 |
| Epiduo | 2.00 |
Product Acceptability and Preference Questionnaire - How do You Rate the Comfort of the Skin Where You Are Currently Treating With the Study Product?
"The subject were presented with a questionnaire at day 14 (end of study) and was asked the following question: How do you rate the comfort of the skin where you are currently treating with the study product?~The subject replied using the following scale:~- Very Comfortable~- Comfortable~- Somewhat Comfortable~- Somewhat Uncomfortable~- Uncomfortable" (NCT00926367)
Timeframe: Day 14
| Intervention | units on a scale (Mean) |
|---|
| Duac | 2.38 |
| Epiduo | 2.23 |
Product Acceptability and Preference Questionnaire - How do You Rate the Ease of Application of the Study Product?
"The subject were presented with a questionnaire at day 14 (end of study) and was asked the following question: Was the study product easy to use with make-up?~The subject replied using the following scale:~0 - Not Applicable~- Very Easy~- Easy~- Neutral~- Difficult~- Very Difficult" (NCT00926367)
Timeframe: Day 14
| Intervention | units on a scale (Mean) |
|---|
| Duac | 1.17 |
| Epiduo | 1.00 |
Product Acceptability and Preference Questionnaire - Was the Study Product Easy to Use With Make-up?
"The subject were presented with a questionnaire at day 14 (end of study) and was asked the following question: Was the study product easy to use with make-up?~The subject replied using the following scale:~0 - Not Applicable~- Very Easy~- Easy~- Neutral~- Difficult~- Very Difficult" (NCT00926367)
Timeframe: Day 14
| Intervention | units on a scale (Mean) |
|---|
| Duac | 1.04 |
| Epiduo | 1.46 |
Product Acceptability and Preference Questionnaire - What Was Your Overall Satisfaction of the Study Product?
"The subject were presented with a questionnaire at day 14 (end of study) and was asked the following question: What was your overall satisfaction of the study product?~The subject replied using the following scale:~- Very Satisfied~- Satisfied~- Neutral~- Unsatisfied~- Very Unsatisfied" (NCT00926367)
Timeframe: Day 14
| Intervention | units on a scale (Mean) |
|---|
| Duac | 2.29 |
| Epiduo | 2.46 |
Self Assessment of Blistering
"The amount of blistering on the left and right cheek of each panelist.~The scale used to evaluate blistering is:~Scale Description:~(scale: 0 = none to 3 = severe)~Subject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14." (NCT00926367)
Timeframe: Baseline, Day 1 through Day 14
| Intervention | units on a scale (Mean) |
|---|
| Baseline | Day 1 | Day 2 | Day 3 | Day 6 | Day 7 | Day 8 | Day 9 | Day 10 | Day 13 | Day 14 |
|---|
| Duac | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 |
,| Epiduo | 0.00 | 0.00 | 0.00 | 0.00 | 0.07 | 0.04 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 |
Self Assessment of Burning
"The amount of burning on the left and right cheek of each panelist.~The scale used to evaluate burning is:~Scale Description:~(scale: 0 = none to 3 = severe)~Subject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14." (NCT00926367)
Timeframe: Baseline, Day 1 through Day 14
| Intervention | units on a scale (Mean) |
|---|
| Baseline | Day 1 | Day 2 | Day 3 | Day 6 | Day 7 | Day 8 | Day 9 | Day 10 | Day 13 | Day 14 |
|---|
| Duac | 0.00 | 0.04 | 0.04 | 0.12 | 0.12 | 0.17 | 0.17 | 0.13 | 0.13 | 0.08 | 0.08 |
,| Epiduo | 0.00 | 0.04 | 0.04 | 0.15 | 0.56 | 0.70 | 0.50 | 0.27 | 0.31 | 0.35 | 0.19 |
Self Assessment of Crusting
"The amount of crusting on the left and right cheek of each panelist.~The scale used to evaluate crusting is:~Scale Description:~(scale: 0 = none to 3 = severe)~Subject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14." (NCT00926367)
Timeframe: Baseline, Day 1 through Day 14
| Intervention | units on a scale (Mean) |
|---|
| Baseline | Day 1 | Day 2 | Day 3 | Day 6 | Day 7 | Day 8 | Day 9 | Day 10 | Day 13 | Day 14 |
|---|
| Duac | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 |
,| Epiduo | 0.00 | 0.00 | 0.00 | 0.00 | 0.07 | 0.04 | 0.04 | 0.04 | 0.04 | 0.00 | 0.00 |
Self Assessment of Dryness
"The amount of dryness on the left and right cheek of each panelist.~The scale used to evaluate dryness is:~Scale Description:~(scale: 0 = none to 3 = severe)~Subject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14." (NCT00926367)
Timeframe: Baseline, Day 1 through Day 14
| Intervention | units on a scale (Mean) |
|---|
| Baseline | Day 1 | Day 2 | Day 3 | Day 6 | Day 7 | Day 8 | Day 9 | Day 10 | Day 13 | Day 14 |
|---|
| Duac | 0.24 | 0.2 | 0.16 | 0.24 | 0.48 | 0.54 | 0.54 | 0.54 | 0.50 | 0.50 | 0.46 |
,| Epiduo | 0.30 | 0.19 | 0.15 | 0.2 | 0.67 | 0.70 | 0.81 | 0.85 | 0.69 | 0.73 | 0.69 |
Self Assessment of Oiliness
"The amount of oiliness on the left and right cheek of each panelist.~The scale used to evaluate oiliness is:~Scale Description:~(scale: 0 = none to 3 = severe)~Subject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14." (NCT00926367)
Timeframe: Baseline, Day 1 through Day 14
| Intervention | units on a scale (Mean) |
|---|
| Baseline | Day 1 | Day 2 | Day 3 | Day 6 | Day 7 | Day 8 | Day 9 | Day 10 | Day 13 | Day 14 |
|---|
| Duac | 0.12 | 0.08 | 0.00 | 0.08 | 0.04 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 |
,| Epiduo | 0.19 | 0.11 | 0.04 | 0.11 | 0.04 | 0.07 | 0.04 | 0.08 | 0.0 | 0.12 | 0.08 |
Self Assessment of Pain
"The amount of pain on the left and right cheek of each panelist.~The scale used to evaluate pain is:~Scale Description:~(scale: 0 = none to 3 = severe)~Subject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14." (NCT00926367)
Timeframe: Baseline, Day 1 through Day 14
| Intervention | units on a scale (Mean) |
|---|
| Baseline | Day 1 | Day 2 | Day 3 | Day 6 | Day 7 | Day 8 | Day 9 | Day 10 | Day 13 | Day 14 |
|---|
| Duac | 0.00 | 0.04 | 0.04 | 0.04 | 0.04 | 0.04 | 0.04 | 0.04 | 0.04 | 0.04 | 0.04 |
,| Epiduo | 0.00 | 0.04 | 0.00 | 0.00 | 0.1 | 0.04 | 0.04 | 0.00 | 0.00 | 0.00 | 0.00 |
Self Assessment of Stinging
"The amount of stinging on the left and right cheek of each panelist.~The scale used to evaluate stinging is:~Scale Description:~(scale: 0 = none to 3 = severe)~Subject Self Assessments of stinging were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14." (NCT00926367)
Timeframe: Baseline, Day 1 through Day 14
| Intervention | units on a scale (Mean) |
|---|
| Baseline | Day 1 | Day 2 | Day 3 | Day 6 | Day 7 | Day 8 | Day 9 | Day 10 | Day 13 | Day 14 |
|---|
| Duac | 0.00 | 0.08 | 0.08 | 0.12 | 0.1 | 0.17 | 0.17 | 0.13 | 0.13 | 0.13 | 0.08 |
,| Epiduo | 0.00 | 0.00 | 0.00 | 0.04 | 0.4 | 0.30 | 0.35 | 0.15 | 0.12 | 0.19 | 0.12 |
Self Assessment of Texture (Roughness)
"The amount of roughness on the left and right cheek of each panelist.~The scale used to evaluate roughness is:~Scale Description:~(scale: 0 = none to 3 = severe)~Subject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14." (NCT00926367)
Timeframe: Baseline, Day 1 through Day 14
| Intervention | units on a scale (Mean) |
|---|
| Baseline | Day 1 | Day 2 | Day 3 | Day 6 | Day 7 | Day 8 | Day 9 | Day 10 | Day 13 | Day 14 |
|---|
| Duac | 0.28 | 0.20 | 0.16 | 0.32 | 0.28 | 0.33 | 0.25 | 0.29 | 0.29 | 0.33 | 0.29 |
,| Epiduo | 0.15 | 0.07 | 0.07 | 0.07 | 0.33 | 0.19 | 0.3 | 0.15 | 0.15 | 0.12 | 0.15 |
Skin Dryness
"The amount of dryness on the left and right cheek of each panelist.~The scale used to evaluate skin dryness is:~Grade Description 0 None 2 Slight flaking 4 Moderate flaking/scaling 6 Marked scaling / slight fissuring 8 Severe scaling, fissuring~Expert Grader assessments of dryness were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14." (NCT00926367)
Timeframe: Baseline, Day 1 through Day 14
| Intervention | units on a scale (Mean) |
|---|
| Baseline | Day 1 | Day 2 | Day 3 | Day 6 | Day 7 | Day 8 | Day 9 | Day 10 | Day 13 | Day 14 |
|---|
| Duac | 0.12 | 0.41 | 0.32 | 0.46 | 0.61 | 0.69 | 0.60 | 0.73 | 0.56 | 0.80 | 0.79 |
,| Epiduo | 0.07 | 0.25 | 0.34 | 0.55 | 1.73 | 1.85 | 1.87 | 2.29 | 1.49 | 1.26 | 1.33 |
Skin Erythema (Redness)
"Assessment of erythema as part of an evaluation of tolerance of two treatments: clindamycin and benzoyl peroxide or dapsone gel. This was done by visual assessment by an independent blinded grader using the grading scale shown below.~Grade Description 0 None 2 Mild erythema 4 Moderate confluent erythema 6 Marked erythema with some edema 8 Marked erythema, edema, possible erosion" (NCT00926367)
Timeframe: Baseline, Day 1 through Day 14
| Intervention | Units on a scale (Mean) |
|---|
| Baseline | Day 1 | Day 2 | Day 3 | Day 6 | Day 7 | Day 8 | Day 9 | Day 10 | Day 13 | Day 14 |
|---|
| Duac | 1.56 | 2.62 | 2.90 | 3.08 | 3.17 | 3.07 | 2.87 | 2.78 | 2.89 | 2.85 | 2.73 |
,| Epiduo | 1.89 | 2.65 | 2.52 | 2.81 | 3.13 | 3.08 | 2.98 | 3.03 | 2.94 | 2.83 | 2.56 |
Skin Hydration
"The ability of an alternating current to flow through the stratum corneum is an indirect measure of its water content. The value recorded is expressed in microsiemens. Higher values indicate greater levels of skin hydration.~Test results were compared to measurements from the other side of the face, which was not treated instead of referring to a normal range. A normal range does not exist for this measurement. Instead, the non-treated side of the face was used as a control to determine the normal level of skin hydration." (NCT00926367)
Timeframe: Baseline, 4 hrs. post 1st Treatment, Days 3, 7, and 14
| Intervention | Microsiemens (Mean) |
|---|
| Baseline | 4 hrs Post 1st Treatment | Day 3 | Day 7 | Day 14 |
|---|
| Duac | 378.06 | 323.47 | 420.97 | 385.91 | 401.98 |
,| Epiduo | 392.09 | 415.90 | 465.25 | 414.77 | 418.51 |
Skin Moisture and Hydration
"To assess skin moisture and hydration using transepidermal water loss (TEWL). Results are measured on a continuous scale. Higher values indicate greater water loss/ lower skin moisture levels.~Evaporative water loss measurements provide an instrumental assessment of skin barrier function(one of the layers of the skin. Damage leads to a disruption of the barrier that is accompanied by elevated water loss rates and affects skin moisture and hydration. Higher values indicate greater water loss." (NCT00926367)
Timeframe: Baseline, Days 3, 7, and 14
| Intervention | TEWL rates (gm/m2/hr) (Mean) |
|---|
| Baseline | Day 3 | Day 7 | Day 14 |
|---|
| Duac | 11.50 | 11.38 | 14.51 | 13.36 |
,| Epiduo | 13.07 | 15.85 | 21.65 | 19.28 |
Changes in the Skin Surface Hydration
"The ability of an alternating current to flow through the stratum corneum is an indirect measure of its water content. The value recorded is expressed in microsiemens. Higher values indicate greater levels of skin hydration.~Test results were compared to measurements from the other side of the face, which was not treated instead of referring to a normal range. A normal range does not exist for this measurement. Instead, the non-treated side of the face was used as a control to determine the normal level of skin hydration." (NCT01015638)
Timeframe: 14 days
| Intervention | microsiemens (Mean) |
|---|
| Day 0 | 4 Hours Post 1st Treatment | Day 3 | Day 7 | Day 14 |
|---|
| Clindamycin and BPO 5% Gel | 546.40 | 554.00 | 572.39 | 484.94 | 361.59 |
,| Clindamycin Phosphate and BPO 2.5% Gel | 478.02 | 430.78 | 529.96 | 413.51 | 354.46 |
Erythema (Redness)
"Compare tolerability of clindamycin and benzoyl peroxide (BPO) 5% and clindamycin phosphate and benzoyl peroxide 2.5% using visual assessments by an independent blinded grader.~Erythema (redness) was evaluated using the following scale:~Erythema Grade Description 0 = None 2 = Mild erythema 4 = Moderate confluent erythema 6 = Marked erythema with some edema 8 = Marked erythema, edema, possible erosion" (NCT01015638)
Timeframe: 14 days
| Intervention | units on a scale (Mean) |
|---|
| Day 0 | Day 1 | Day 2 | Day 3 | Day 6 | Day 7 | Day 8 | Day 9 | Day 10 | Day 13 | Day 14 |
|---|
| Clindamycin and BPO 5% Gel | 0.94 | 1.42 | 1.45 | 1.27 | 1.55 | 1.72 | 1.39 | 1.38 | 1.78 | 1.34 | 1.51 |
,| Clindamycin Phosphate and BPO 2.5% Gel | 1.05 | 1.24 | 1.49 | 1.36 | 1.87 | 1.88 | 1.70 | 1.82 | 1.72 | 1.82 | 1.82 |
Skin Dryness
"Visual Dryness was evaluated using the following scale:~Grade 0 = None 2 = Slight flaking 4 = Moderate flaking/scaling 6 = Marked scaling / slight fissuring 8 Severe scaling, fissuring" (NCT01015638)
Timeframe: 14 days
| Intervention | units on a scale (Mean) |
|---|
| Day 0 | Day 1 | Day 2 | Day 3 | Day 6 | Day 7 | Day 8 | Day 9 | Day 10 | Day 13 | Day 14 |
|---|
| Clindamycin and BPO 5% Gel | 0.06 | 0.05 | 0.05 | 0.27 | 0.29 | 0.32 | 0.40 | 0.35 | 0.47 | 0.76 | 0.62 |
,| Clindamycin Phosphate and BPO 2.5% Gel | 0.05 | 0.15 | 0.37 | 0.22 | 0.24 | 0.15 | 0.15 | 0.15 | 0.36 | 0.28 | 0.31 |
Skin Moisture and Hydration
"To assess skin moisture and hydration using transepidermal water loss (TEWL). Results are measured on a continuous scale as grams per meters squared (m^2) per hour. Higher values indicate greater water loss/ lower skin moisture levels.~Evaporative water loss measurements provide an instrumental assessment of skin barrier function(one of the layers of the skin. Damage leads to a disruption of the barrier that is accompanied by elevated water loss rates and affects skin moisture and hydration." (NCT01015638)
Timeframe: 14 days
| Intervention | grams/m^2/hour (Mean) |
|---|
| Day 0 | Day 3 | Day 7 | Day 14 |
|---|
| Clindamycin and BPO 5% Gel | 10.82 | 11.98 | 13.01 | 13.94 |
,| Clindamycin Phosphate and BPO 2.5% Gel | 9.71 | 10.84 | 11.36 | 13.59 |
Subject Assessment - Blistering
"At each visit, panelists were supplied a self-assessment questionnaire. Subjects were asked to evaluate blistering, burning, stinging, and dryness in this questionnaire. Each symptom will be rated with the following scale: 0 - None, 1 - Slight, 2 - Moderate, or 3 - Severe.~The subjects completed this questionnaire prior to their daily application. The subjects used the time period (last 24 hours), from their last study application to the time they are administered this questionnaire for rating each symptom. The results for assessment of blistering are presented here." (NCT01015638)
Timeframe: 2 Weeks
| Intervention | units on a scale (Mean) |
|---|
| Day 0 | Day 1 | Day 2 | Day 3 | Day 6 | Day 7 | Day 8 | Day 9 | Day 10 | Day 13 | Day 14 |
|---|
| Clindamycin and BPO 5% Gel | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 |
,| Clindamycin Phosphate and BPO 2.5% Gel | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 |
Subject Assessment - Crusting
"At each visit, panelists were supplied a self-assessment questionnaire. Subjects were asked to evaluate crusting, burning, stinging, and dryness in this questionnaire. Each symptom will be rated with the following scale: 0 - None, 1 - Slight, 2 - Moderate, or 3 - Severe.~The subjects completed this questionnaire prior to their daily application. The subjects used the time period (last 24 hours), from their last study application to the time they are administered this questionnaire for rating each symptom. The results for assessment of crusting are presented here." (NCT01015638)
Timeframe: 2 Weeks
| Intervention | units on a scale (Mean) |
|---|
| Day 0 | Day 1 | Day 2 | Day 3 | Day 6 | Day 7 | Day 8 | Day 9 | Day 10 | Day 13 | Day 14 |
|---|
| Clindamycin and BPO 5% Gel | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 |
,| Clindamycin Phosphate and BPO 2.5% Gel | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 |
Subject Assessment - Dryness
"At each visit, panelists were supplied a self-assessment questionnaire. Subjects were asked to evaluate burning, stinging, and dryness in this questionnaire. Each symptom will be rated with the following scale: 0 - None, 1 - Slight, 2 - Moderate, or 3 - Severe.~The subjects completed this questionnaire prior to their daily application. The subjects used the time period (last 24 hours), from their last study application to the time they are administered this questionnaire for rating each symptom. The results for assessment of dryness are presented here." (NCT01015638)
Timeframe: 2 weeks
| Intervention | units on a scale (Mean) |
|---|
| Day 0 | Day 1 | Day 2 | Day 3 | Day 6 | Day 7 | Day 8 | Day 9 | Day 10 | Day 13 | Day 14 |
|---|
| Clindamycin and BPO 5% Gel | 0.00 | 0.00 | 0.00 | 0.00 | 0.06 | 0.12 | 0.12 | 0.2 | 0.24 | 0.35 | 0.24 |
,| Clindamycin Phosphate and BPO 2.5% Gel | 0.26 | 0.26 | 0.21 | 0.11 | 0.11 | 0.21 | 0.16 | 0.16 | 0.16 | 0.16 | 0.21 |
Subject Assessment - Oiliness
"At each visit, panelists were supplied a self-assessment questionnaire. Subjects were asked to evaluate oiliness, burning, stinging, and dryness in this questionnaire. Each symptom will be rated with the following scale: 0 - None, 1 - Slight, 2 - Moderate, or 3 - Severe.~The subjects completed this questionnaire prior to their daily application. The subjects used the time period (last 24 hours), from their last study application to the time they are administered this questionnaire for rating each symptom. The results for assessment of oiliness are presented here." (NCT01015638)
Timeframe: 2 Weeks
| Intervention | units on a scale (Mean) |
|---|
| Day 0 | Day 1 | Day 2 | Day 3 | Day 6 | Day 7 | Day 8 | Day 9 | Day 10 | Day 13 | Day 14 |
|---|
| Clindamycin and BPO 5% Gel | 0.18 | 0.18 | 0.06 | 0.12 | 0.06 | 0.06 | 0.06 | 0.06 | 0.00 | 0.00 | 0.00 |
,| Clindamycin Phosphate and BPO 2.5% Gel | 0.16 | 0.05 | 0.00 | 0.11 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 |
Subject Assessment - Pain
"At each visit, panelists were supplied a self-assessment questionnaire, which included assessment of pain.~Subjects were asked to evaluate burning, stinging, pain, and dryness in this questionnaire. Each symptom will be rated with the following scale: 0 - None, 1 - Slight, 2 - Moderate, or 3 - Severe.~The subjects completed this questionnaire prior to their daily application. The subjects used the time period (last 24 hours), from their last study application to the time they are administered this questionnaire for rating each symptom. The results for assessment of pain are presented here." (NCT01015638)
Timeframe: 2 Weeks
| Intervention | units on a scale (Mean) |
|---|
| Day 0 | Day 1 | Day 2 | Day 3 | Day 6 | Day 7 | Day 8 | Day 9 | Day 10 | Day 13 | Day 14 |
|---|
| Clindamycin and BPO 5% Gel | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 |
,| Clindamycin Phosphate and BPO 2.5% Gel | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 |
Subject Assessment - Roughness
"At each visit, panelists were supplied a self-assessment questionnaire. Subjects were asked to evaluate burning, stinging, roughness, and dryness in this questionnaire. Each symptom will be rated with the following scale: 0 - None, 1 - Slight, 2 - Moderate, or 3 - Severe.~The subjects completed this questionnaire prior to their daily application. The subjects used the time period (last 24 hours), from their last study application to the time they are administered this questionnaire for rating each symptom. The results for assessment of roughness are presented here." (NCT01015638)
Timeframe: 2 weeks
| Intervention | units on a scale (Mean) |
|---|
| Day 0 | Day 1 | Day 2 | Day 3 | Day 6 | Day 7 | Day 8 | Day 9 | Day 10 | Day 13 | Day 14 |
|---|
| Clindamycin and BPO 5% Gel | 0.00 | 0.00 | 0.00 | 0.00 | 0.06 | 0.06 | 0.06 | 0.18 | 0.12 | 0.00 | 0.00 |
,| Clindamycin Phosphate and BPO 2.5% Gel | 0.00 | 0.05 | 0.00 | 0.00 | 0.00 | 0.00 | 0.05 | 0.05 | 0.05 | 0.05 | 0.05 |
Subject Tolerability - Burning
"At each visit, panelists were supplied a self-assessment questionnaire. Subjects were asked to evaluate burning, stinging, pain, and dryness in this questionnaire. Each symptom was rated with the following scale: 0 - None, 1 - Slight, 2 - Moderate, or 3 - Severe.~The subjects completed this questionnaire prior to their daily application. The subjects used the time period (last 24 hours), from their last study application to the time they are administered this questionnaire for rating each symptom. The results for assessment of burning are presented here." (NCT01015638)
Timeframe: 2 weeks
| Intervention | units on a scale (Mean) |
|---|
| Day 0 | Day 1 | Day 2 | Day 3 | Day 6 | Day 7 | Day 8 | Day 9 | Day 10 | Day 13 | Day 14 |
|---|
| Clindamycin and BPO 5% Gel | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 |
,| Clindamycin Phosphate and BPO 2.5% Gel | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 |
Subject Tolerability - Stinging
"At each visit, panelists were supplied a self-assessment questionnaire. Subjects were asked to evaluate burning, stinging, and dryness in this questionnaire. Each symptom will be rated with the following scale: 0 - None,1 - Slight,2 - Moderate, or 3 - Severe.~The subjects completed this questionnaire prior to their daily application. The subjects used the time period (last 24 hours), from their last study application to the time they are administered this questionnaire for rating each symptom. The results for assessment of stinging are presented here." (NCT01015638)
Timeframe: 2 weeks
| Intervention | units on a scale (Mean) |
|---|
| Day 0 | Day 1 | Day 2 | Day 3 | Day 6 | Day 7 | Day 8 | Day 9 | Day 10 | Day 13 | Day 14 |
|---|
| Clindamycin and BPO 5% Gel | 0.00 | 0.00 | 0.06 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 |
,| Clindamycin Phosphate and BPO 2.5% Gel | 0.00 | 0.00 | 0.00 | 0.05 | 0.05 | 0.00 | 0.00 | 0.00 | 0.05 | 0.00 | 0.11 |
Proportion of Participants With a Minimum 2-grade Improvement in the Investigator's Static Global Assessment (ISGA) Score From Baseline to Week 12
An ISGA was obtained at Baseline and at Weeks 2, 4, 8, and 12. The scores range from 0-5 (0=clear skin with no inflammatory or non-inflammatory lesions; 5=very severe with many non-inflammatory and inflammatory lesions and more than a few nodular lesions (may have cystic lesions). The higher score indicates more severe. The area considered for the ISGA was confined to the face. When possible, the same efficacy assessor performed all ISGA assessments on the same participant at all visits. Day 1 (Visit 1) was defined as Baseline. Only participants available at specified time points were analyzed. (NCT00713609)
Timeframe: Baseline and up to Week 12
| Intervention | Percentage of participants (Number) |
|---|
| Benzoyl Peroxide/Clindamycin + Tazarotene | 22 |
| Benzoyl Peroxide/Clindamycin + Vehicle Cream | 22 |
| Benzoyl Peroxide Gel + Tazarotene | 31 |
| Clindamycin Gel + Tazarotene | 36 |
| Vehicle Gel + Tazarotene | 20 |
| Vehicle Gel + Vehicle Cream | 5 |
Proportion of Participants With an ISGA Score of 0 or 1 at Week 12
An ISGA was obtained at Baseline and at Weeks 2, 4, 8, and 12. The scores range from 0-5 (0=clear skin with no inflammatory or non-inflammatory lesions; 5=very severe with many non-inflammatory and inflammatory lesions and more than a few nodular lesions (may have cystic lesions). The higher score indicates more severe. The area considered for the ISGA was confined to the face. When possible, the same efficacy assessor performed all ISGA assessments on the same participant at all visits. Day 1 (Visit 1) was defined as Baseline. Only participants available at specified time points were analyzed. (NCT00713609)
Timeframe: Week 12
| Intervention | Percentage of participants (Number) |
|---|
| Benzoyl Peroxide/Clindamycin + Tazarotene | 33 |
| Benzoyl Peroxide/Clindamycin + Vehicle Cream | 31 |
| Benzoyl Peroxide Gel + Tazarotene | 27 |
| Clindamycin Gel + Tazarotene | 39 |
| Vehicle Gel + Tazarotene | 22 |
| Vehicle Gel + Vehicle Cream | 13 |
Absolute Change in Lesion Counts (Total, Inflammatory, and Non-inflammatory) From Baseline to Week 12
The investigator or designee took count of inflammatory lesions (papules, pustules, nodules and cysts [only post-Baseline]) (ILC), noninflammatory lesions (open and closed comedones) (NILC) and total lesions (TLC) at Baseline, Weeks 2, 4, 8, and 12. Lesion counts were confined to the face. Each of 3 lesion counts (total, inflammatory and non-inflammatory) was analyzed using an analysis of covariance (ANCOVA) model with terms for treatment, center, Baseline value and treatment-by-center interaction. If the interaction was not significant at 0.1 level, this interaction was excluded in ANCOVA model. Day 1 (Visit 1) was defined as Baseline. Only participants available at specified timepoints were analyzed (represented by n=X in the category titles). (NCT00713609)
Timeframe: Baseline and up to Week 12
| Intervention | Lesion count (Mean) |
|---|
| ILC, n=101, 103, 105, 105, 104, 52 | NILC, n=101, 103, 105, 105, 104, 52 | TLC, n=101, 103, 105, 105, 104, 52 |
|---|
| Benzoyl Peroxide Gel + Tazarotene | -18.9 | -37.1 | -56.0 |
,| Benzoyl Peroxide/Clindamycin + Tazarotene | -16.8 | -33.0 | -49.8 |
,| Benzoyl Peroxide/Clindamycin + Vehicle Cream | -18.1 | -24.9 | -43.0 |
,| Clindamycin Gel + Tazarotene | -18.8 | -37.5 | -56.3 |
,| Vehicle Gel + Tazarotene | -14.5 | -33.0 | -47.6 |
,| Vehicle Gel + Vehicle Cream | -8.96 | -18.9 | -27.8 |
Percent Change From Baseline to Week 12 in Each of 3 Lesion Counts (Total, Inflammatory, and Non-inflammatory)
The investigator or designee took count of inflammatory lesions (papules, pustules, nodules and cysts) (ILC), noninflammatory lesions (open and closed comedones) (NILC) and total lesions (TLC) at Baseline, Weeks 2, 4, 8, and 12. Lesion counts were confined to the face. Each of 3 lesion counts (total, inflammatory and non-inflammatory) was analyzed using an analysis of covariance (ANCOVA) model with terms for treatment, center, Baseline value and treatment-by-center interaction. If the interaction was not significant at 0.1 level, this interaction was excluded in ANCOVA model. Day 1 (Visit 1) was defined as Baseline. Only participants available at specified timepoints were analyzed (represented by n=X in the category titles). (NCT00713609)
Timeframe: Baseline and up to Week 12
| Intervention | Percent change (Mean) |
|---|
| ILC, n=101, 103, 105, 105, 104, 52 | NILC, n=101, 103, 105, 105, 104, 52 | TLC, n=101, 103, 105, 105, 104, 52 |
|---|
| Benzoyl Peroxide Gel + Tazarotene | -62.4 | -60.6 | -62.0 |
,| Benzoyl Peroxide/Clindamycin + Tazarotene | -58.3 | -58.0 | -59.1 |
,| Benzoyl Peroxide/Clindamycin + Vehicle Cream | -62.4 | -39.2 | -47.9 |
,| Clindamycin Gel + Tazarotene | -65.7 | -61.2 | -63.4 |
,| Vehicle Gel + Tazarotene | -49.0 | -53.1 | -51.8 |
,| Vehicle Gel + Vehicle Cream | -33.5 | -29.5 | -31.5 |
Mean Days Missed From Normal Activities in the Intent to Treat Population
As a quality of life measure, participants maintained a memory aid from Day 1 to Day 14 to track measures such as participation in normal life activities. The maximum number of days assessed, 14, was assigned to participants who had not yet resumed normal activities by the end of the assessment period. (NCT00729937)
Timeframe: Day 1 through 14
| Intervention | days (Mean) |
|---|
| Abscess, Placebo | 2.5 |
| Abscess, TMP/SMX | 2.1 |
| Infected Wound, TMP/SMX | 2.6 |
| Infected Wound, Clindamycin | 2.1 |
| Cellulitis, Cephalexin and TMP/SMX | 2.2 |
| Cellulitis, Cephalexin | 2.7 |
Mean Days Missed From Normal Activities in the Per Protocol Population
As a quality of life measure, participants maintained a memory aid from Day 1 to Day 14 to track measures such as participation in normal life activities. The maximum number of days assessed, 14, was assigned to participants who had not yet resumed normal activities by the end of the assessment period. (NCT00729937)
Timeframe: Day 1 through 14
| Intervention | days (Mean) |
|---|
| Abscess, Placebo | 2.6 |
| Abscess, TMP/SMX | 2.0 |
| Infected Wound, TMP/SMX | 2.7 |
| Infected Wound, Clindamycin | 2.1 |
| Cellulitis, Cephalexin and TMP/SMX | 2.2 |
| Cellulitis, Cephalexin | 2.5 |
Number of Participants Requiring Surgical Intervention Through the Extended Follow-up Visit (EFV) in the Intent to Treat Population
All surgical procedures such as incision and drainage (I&D) and debridement that were related to the current infection under study or significant to the health of the subject, except for the initial I&D of an abscess for participants in the abscess or infected wound arms, were recorded. Participants who required a surgical intervention between the initial enrollment (excluding the initial I&D as applicable) and the extended follow-up visit are summarized. (NCT00729937)
Timeframe: Day 1 through Day 49-63
| Intervention | participants (Number) |
|---|
| Abscess, Placebo | 76 |
| Abscess, TMP/SMX | 52 |
| Infected Wound, TMP/SMX | 20 |
| Infected Wound, Clindamycin | 12 |
| Cellulitis, Cephalexin and TMP/SMX | 33 |
| Cellulitis, Cephalexin | 31 |
Number of Participants Requiring Surgical Intervention Through the Extended Follow-up Visit (EFV) in the Per Protocol Population
All surgical procedures such as incision and drainage (I&D) and debridement that were related to the current infection under study or significant to the health of the subject, except for the initial I&D of an abscess for participants in the abscess or infected wound arms, were recorded. Participants who required a surgical intervention between the initial enrollment (excluding the initial I&D as applicable) and the extended follow-up visit are summarized. (NCT00729937)
Timeframe: Day 1 through Day 49-63
| Intervention | participants (Number) |
|---|
| Abscess, Placebo | 69 |
| Abscess, TMP/SMX | 42 |
| Infected Wound, TMP/SMX | 17 |
| Infected Wound, Clindamycin | 8 |
| Cellulitis, Cephalexin and TMP/SMX | 33 |
| Cellulitis, Cephalexin | 20 |
Number of Participants Requiring Surgical Intervention Through the TOC Visit in the Intent to Treat Population
All surgical procedures such as incision and drainage (I&D) and debridement that were related to the current infection under study or significant to the health of the subject, except for the initial I&D of an abscess for participants in the abscess or infected wound arms, were recorded. Participants who required a surgical intervention between the initial enrollment (excluding the initial I&D as applicable) and the test-of-cure visit are summarized. (NCT00729937)
Timeframe: Day 1 through Day 14-21
| Intervention | participants (Number) |
|---|
| Abscess, Placebo | 52 |
| Abscess, TMP/SMX | 25 |
| Infected Wound, TMP/SMX | 16 |
| Infected Wound, Clindamycin | 9 |
| Cellulitis, Cephalexin and TMP/SMX | 26 |
| Cellulitis, Cephalexin | 28 |
Number of Participants Requiring Surgical Intervention Through the TOC Visit in the Per Protocol Population
All surgical procedures such as incision and drainage (I&D) and debridement that were related to the current infection under study or significant to the health of the subject, except for the initial I&D of an abscess for participants in the abscess or infected wound arms, were recorded. Participants who required a surgical intervention between the initial enrollment (excluding the initial I&D as applicable) and the test-of-cure visit are summarized. (NCT00729937)
Timeframe: Day 1 through Day 14-21
| Intervention | participants (Number) |
|---|
| Abscess, Placebo | 46 |
| Abscess, TMP/SMX | 18 |
| Infected Wound, TMP/SMX | 13 |
| Infected Wound, Clindamycin | 6 |
| Cellulitis, Cephalexin and TMP/SMX | 26 |
| Cellulitis, Cephalexin | 17 |
Number of Participants Who Developed a Recurrent Infection at the Original Infection Site Through the EFV Visit in the Intent to Treat Population
Participants were evaluated for the development of a recurrent, or repeat, infection at the original infection site. Participants who were reported to have developed a recurrent infection though the extended follow-up visit are summarized. (NCT00729937)
Timeframe: Day 1 through Day 49-63
| Intervention | participants (Number) |
|---|
| Abscess, Placebo | 26 |
| Abscess, TMP/SMX | 30 |
| Infected Wound, TMP/SMX | 16 |
| Infected Wound, Clindamycin | 6 |
| Cellulitis, Cephalexin and TMP/SMX | 35 |
| Cellulitis, Cephalexin | 31 |
Number of Participants Who Developed a Recurrent Infection at the Original Infection Site Through the EFV Visit in the Per Protocol Population
Participants were evaluated for the development of a recurrent, or repeat, infection at the original infection site. Participants who were reported to have developed a recurrent infection though the extended follow-up visit are summarized. (NCT00729937)
Timeframe: Day 1 through Day 49-63
| Intervention | participants (Number) |
|---|
| Abscess, Placebo | 23 |
| Abscess, TMP/SMX | 26 |
| Infected Wound, TMP/SMX | 14 |
| Infected Wound, Clindamycin | 4 |
| Cellulitis, Cephalexin and TMP/SMX | 33 |
| Cellulitis, Cephalexin | 24 |
Number of Participants Who Developed a Recurrent Infection at the Original Infection Site Through the TOC Visit in the Intent to Treat Population
Participants were evaluated for the development of a recurrent, or repeat, infection at the original infection site. Participants who were reported to have developed a recurrent infection though the test-of-cure visit are summarized. (NCT00729937)
Timeframe: Day 1 through Day 14-21
| Intervention | participants (Number) |
|---|
| Abscess, Placebo | 17 |
| Abscess, TMP/SMX | 13 |
| Infected Wound, TMP/SMX | 15 |
| Infected Wound, Clindamycin | 4 |
| Cellulitis, Cephalexin and TMP/SMX | 32 |
| Cellulitis, Cephalexin | 29 |
Number of Participants Who Developed a Recurrent Infection at the Original Infection Site Through the TOC Visit in the Per Protocol Population
Participants were evaluated for the development of a recurrent, or repeat, infection at the original infection site. Participants who were reported to have developed a recurrent infection though the test-of-cure visit are summarized. (NCT00729937)
Timeframe: Day 1 through Day 14-21
| Intervention | participants (Number) |
|---|
| Abscess, Placebo | 16 |
| Abscess, TMP/SMX | 11 |
| Infected Wound, TMP/SMX | 13 |
| Infected Wound, Clindamycin | 3 |
| Cellulitis, Cephalexin and TMP/SMX | 30 |
| Cellulitis, Cephalexin | 22 |
Number of Participants With Development of an Invasive Infection Through the EFV Visit in the Intent to Treat Population
Participants were evaluated for invasive infection, which included, but was not limited to, findings of severe sepsis/septic shock, endocarditis, pneumonia, necrotizing soft tissue, osteomyelitis, and bacteremia. A positive response to at least one finding was considered invasive infection for this outcome measure. (NCT00729937)
Timeframe: Day 1 through Day 49-63
| Intervention | participants (Number) |
|---|
| Abscess, Placebo | 3 |
| Abscess, TMP/SMX | 2 |
| Infected Wound, TMP/SMX | 0 |
| Infected Wound, Clindamycin | 0 |
| Cellulitis, Cephalexin and TMP/SMX | 1 |
| Cellulitis, Cephalexin | 0 |
Number of Participants With Development of an Invasive Infection Through the EFV Visit in the Per Protocol Population
Participants were evaluated for invasive infection, which included, but was not limited to, findings of severe sepsis/septic shock, endocarditis, pneumonia, necrotizing soft tissue, osteomyelitis, and bacteremia. A positive response to at least one finding was considered invasive infection for this outcome measure. (NCT00729937)
Timeframe: Day 1 through Day 49-63
| Intervention | participants (Number) |
|---|
| Abscess, Placebo | 2 |
| Abscess, TMP/SMX | 2 |
| Infected Wound, TMP/SMX | 0 |
| Infected Wound, Clindamycin | 0 |
| Cellulitis, Cephalexin and TMP/SMX | 1 |
| Cellulitis, Cephalexin | 0 |
Number of Participants With Development of an Invasive Infection Through the TOC Visit in the Intent to Treat Population
Participants were evaluated for invasive infection, which included, but was not limited to, findings of severe sepsis/septic shock, endocarditis, pneumonia, necrotizing soft tissue, osteomyelitis, and bacteremia. A positive response to at least one finding was considered invasive infection for this outcome measure. (NCT00729937)
Timeframe: Day 1 through Day 14-21
| Intervention | participants (Number) |
|---|
| Abscess, Placebo | 1 |
| Abscess, TMP/SMX | 1 |
| Infected Wound, TMP/SMX | 0 |
| Infected Wound, Clindamycin | 0 |
| Cellulitis, Cephalexin and TMP/SMX | 0 |
| Cellulitis, Cephalexin | 0 |
Number of Participants With Development of an Invasive Infection Through the TOC Visit in the Per Protocol Population
Participants were evaluated for invasive infection, which included, but was not limited to, findings of severe sepsis/septic shock, endocarditis, pneumonia, necrotizing soft tissue, osteomyelitis, and bacteremia. A positive response to at least one finding was considered invasive infection for this outcome measure. (NCT00729937)
Timeframe: Day 1 through Day 14-21
| Intervention | participants (Number) |
|---|
| Abscess, Placebo | 0 |
| Abscess, TMP/SMX | 1 |
| Infected Wound, TMP/SMX | 0 |
| Infected Wound, Clindamycin | 0 |
| Cellulitis, Cephalexin and TMP/SMX | 0 |
| Cellulitis, Cephalexin | 0 |
Number of Participants by Composite Clinical Outcome at the TOC Visit in the Per Protocol Population
Participants were categorized as composite clinical cure if they had resolution of all symptoms/signs of infection, or improvement to such an extent that no additional antibiotic therapy and/or surgical procedures were necessary. Participants were categorized as composite clinical failure if they had lack of resolution of all signs and symptoms of infection to such an extent that further antibiotic therapy and/or surgical procedures were necessary. (NCT00729937)
Timeframe: Day 14-21
| Intervention | participants (Number) |
|---|
| Composite Clinical Cure | Composite Clinical Failure |
|---|
| Abscess, Placebo | 396 | 137 |
,| Abscess, TMP/SMX | 453 | 71 |
,| Cellulitis, Cephalexin | 149 | 44 |
,| Cellulitis, Cephalexin and TMP/SMX | 160 | 58 |
,| Infected Wound, Clindamycin | 114 | 89 |
,| Infected Wound, TMP/SMX | 113 | 85 |
Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population
As a quality of life measure, participants maintained a memory aid from Day 1 to Day 14 to track measures such as use of other, non-study medications such as analgesics. Each participant is summarized by the last day of reported analgesic usage, from the start of treatment with study intervention. The maximum number of days assessed, 14, was assigned to participants who were still taking analgesic medications by the end of the assessment period. (NCT00729937)
Timeframe: Day 1 through 14
| Intervention | participants (Number) |
|---|
| Day 1 | Day 2 | Day 3 | Day 4 | Day 5 | Day 6 | Day 7 | Day 8 | Day 9 | Day 10 | Day 11 | Day 12 | Day 13 | Day 14 |
|---|
| Abscess, Placebo | 58 | 38 | 45 | 47 | 27 | 34 | 27 | 34 | 24 | 14 | 19 | 19 | 15 | 146 |
,| Abscess, TMP/SMX | 81 | 34 | 64 | 34 | 42 | 29 | 32 | 40 | 26 | 15 | 10 | 14 | 5 | 127 |
,| Cellulitis, Cephalexin | 28 | 6 | 10 | 13 | 4 | 22 | 8 | 6 | 6 | 4 | 2 | 6 | 3 | 45 |
,| Cellulitis, Cephalexin and TMP/SMX | 18 | 7 | 15 | 16 | 10 | 10 | 9 | 10 | 9 | 5 | 3 | 1 | 2 | 51 |
,| Infected Wound, Clindamycin | 37 | 10 | 24 | 10 | 9 | 13 | 12 | 11 | 9 | 4 | 4 | 3 | 7 | 50 |
,| Infected Wound, TMP/SMX | 32 | 15 | 18 | 16 | 9 | 13 | 13 | 8 | 4 | 6 | 2 | 4 | 2 | 59 |
Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population
As a quality of life measure, participants maintained a memory aid from Day 1 to Day 14 to track measures such as use of other, non-study medications such as analgesics. Each participant is summarized by the last day of reported analgesic usage, from the start of treatment with study intervention. The maximum number of days assessed, 14, was assigned to participants who were still taking analgesic medications by the end of the assessment period. (NCT00729937)
Timeframe: Day 1 through 14
| Intervention | participants (Number) |
|---|
| Day 1 | Day 2 | Day 3 | Day 4 | Day 5 | Day 6 | Day 7 | Day 8 | Day 9 | Day 10 | Day 11 | Day 12 | Day 13 | Day 14 |
|---|
| Abscess, Placebo | 44 | 37 | 41 | 39 | 24 | 29 | 24 | 31 | 22 | 12 | 16 | 18 | 12 | 130 |
,| Abscess, TMP/SMX | 56 | 32 | 49 | 32 | 40 | 27 | 27 | 35 | 21 | 13 | 10 | 12 | 3 | 107 |
,| Cellulitis, Cephalexin | 17 | 5 | 7 | 7 | 4 | 19 | 6 | 5 | 4 | 3 | 1 | 6 | 2 | 38 |
,| Cellulitis, Cephalexin and TMP/SMX | 14 | 7 | 13 | 15 | 9 | 9 | 9 | 9 | 9 | 4 | 3 | 1 | 2 | 45 |
,| Infected Wound, Clindamycin | 29 | 9 | 18 | 9 | 9 | 11 | 12 | 10 | 7 | 4 | 4 | 1 | 6 | 40 |
,| Infected Wound, TMP/SMX | 23 | 11 | 17 | 14 | 7 | 10 | 10 | 7 | 3 | 5 | 2 | 4 | 2 | 46 |
Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class
All adverse events were recorded through the test of cure visit; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit. All AEs were assessed for association with the study product by a clinician and were considered associated with study product if the event was temporally related to the administration of the study product and no other etiology more likely explains the event. Associated adverse events are summarized by MedDRA System Organ Class. (NCT00729937)
Timeframe: Day 1 through Day 49-63
| Intervention | participants (Number) |
|---|
| Cardiac disorders | Eye disorders | Gastrointestinal disorders | General disorders and administration site conditio | Infections and infestations | Injury, poisoning and procedural complications | Investigations | Metabolism and nutrition disorders | Musculoskeletal and connective tissue disorders | Nervous system disorders | Psychiatric disorders | Renal and urinary disorders | Reproductive system and breast disorders | Respiratory, thoracic and mediastinal disorders | Skin and subcutaneous tissue disorders | Vascular disorders |
|---|
| Abscess, Placebo | 0 | 3 | 164 | 6 | 5 | 1 | 1 | 7 | 3 | 38 | 0 | 2 | 1 | 3 | 10 | 2 |
,| Abscess, TMP/SMX | 0 | 1 | 198 | 11 | 4 | 0 | 0 | 11 | 3 | 44 | 1 | 0 | 0 | 0 | 14 | 0 |
,| Cellulitis, Cephalexin | 0 | 0 | 73 | 2 | 1 | 0 | 0 | 0 | 0 | 20 | 0 | 0 | 0 | 0 | 7 | 0 |
,| Cellulitis, Cephalexin and TMP/SMX | 0 | 0 | 87 | 2 | 1 | 0 | 0 | 3 | 0 | 16 | 0 | 1 | 1 | 0 | 15 | 0 |
,| Infected Wound, Clindamycin | 1 | 0 | 93 | 1 | 1 | 0 | 0 | 4 | 0 | 15 | 0 | 0 | 1 | 0 | 6 | 0 |
,| Infected Wound, TMP/SMX | 0 | 0 | 82 | 3 | 1 | 0 | 1 | 2 | 0 | 16 | 0 | 1 | 0 | 0 | 5 | 0 |
Number of Participants With Clinical Cure as of the Test-of-Cure (TOC) Visit in the Per Protocol Population
Clinical cure at TOC was defined as no failure on any previous visit up through the TOC, absence of fever, and resolution or minimal presence of all the following signs and symptoms from baseline based on clinician assessment of erythema, swelling, and tenderness. A participant would have been a clinical failure at the On Therapy (OTV) visit with presence of fever attributable to the infection being studied, increase in erythema by 25% or more, or worsening of both swelling and tenderness based on clinical assessment. A participant would have been a clinical failure at the End of Therapy (EOT) visit with presence of fever attributable to the infection being studied, increase or no improvement in erythema, or no improvement in either swelling or tenderness based on clinical assessment. (NCT00729937)
Timeframe: Days 14-21
| Intervention | participants (Number) |
|---|
| Clinical Cure | Clinical Failure |
|---|
| Abscess, Placebo | 457 | 76 |
,| Abscess, TMP/SMX | 487 | 37 |
,| Cellulitis, Cephalexin | 165 | 28 |
,| Cellulitis, Cephalexin and TMP/SMX | 182 | 36 |
,| Infected Wound, Clindamycin | 187 | 16 |
,| Infected Wound, TMP/SMX | 182 | 16 |
Number of Participants With Clinical Cure as of the TOC Visit in the Intent to Treat Population
Clinical cure at TOC was defined as no failure on any previous visit up through the TOC, absence of fever, and resolution or minimal presence of all the following signs and symptoms from baseline based on clinician assessment of erythema, swelling, and tenderness. A participant would have been a clinical failure at the On Therapy (OTV) visit with presence of fever attributable to the infection being studied, increase in erythema by 25% or more, or worsening of both swelling and tenderness based on clinical assessment. A participant would have been a clinical failure at the End of Therapy (EOT) visit with presence of fever attributable to the infection being studied, increase or no improvement in erythema, or no improvement in either swelling or tenderness based on clinical assessment. (NCT00729937)
Timeframe: Days 14-21
| Intervention | participants (Number) |
|---|
| Clinical Cure | Clinical Failure |
|---|
| Abscess, Placebo | 454 | 163 |
,| Abscess, TMP/SMX | 507 | 123 |
,| Cellulitis, Cephalexin | 171 | 77 |
,| Cellulitis, Cephalexin and TMP/SMX | 189 | 59 |
,| Infected Wound, Clindamycin | 198 | 51 |
,| Infected Wound, TMP/SMX | 197 | 53 |
Number of Participants With Each Microbiological Outcome at the TOC Visit in the Per Protocol Population
Participants were categorized for the microbiological outcome with Presumed eradication if they were not deemed a clinical failure through TOC. Those who were deemed a clinical failure through the TOC were classified as one of the following: Persistence=persistent growth of a pre-therapy pathogen; New infection=growth of a new pathogen and eradication of initial pathogen; Super-infection=growth of a new pathogen in addition to persistent growth of pre-therapy pathogen; Unclassified=no specimen for culture or growth of a pathogen in subsequent culture specimen of cellulitis participants, or for whom initial culture specimens were negative or were not obtained for infected wound and abscess participants; or Indeterminate=not meeting any one of the above microbiologic outcome criteria. (NCT00729937)
Timeframe: Day 14-21
| Intervention | participants (Number) |
|---|
| Presumed eradication | Persistence | New infection | Super-infection | Unclassified | Indeterminate |
|---|
| Abscess, Placebo | 457 | 39 | 1 | 8 | 28 | 0 |
,| Abscess, TMP/SMX | 487 | 15 | 0 | 4 | 18 | 0 |
,| Cellulitis, Cephalexin | 165 | 0 | 0 | 0 | 11 | 17 |
,| Cellulitis, Cephalexin and TMP/SMX | 182 | 0 | 0 | 0 | 13 | 23 |
,| Infected Wound, Clindamycin | 187 | 6 | 1 | 0 | 9 | 0 |
,| Infected Wound, TMP/SMX | 182 | 5 | 2 | 0 | 9 | 0 |
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population
The area of erythema was measured in square centimeters at baseline and at the end-of-therapy visit. For each subject, the change in area was calculated as the area at end-of-therapy subtracted from the area at baseline. The change in area was then divided by the original area to determine the proportional change. Participants were then categorized by reductions in 5% intervals, with participants whose erythema did not change or increased categorized as no reduction. (NCT00729937)
Timeframe: Day 1 to Day 8-10
| Intervention | participants (Number) |
|---|
| No reduction | >0%-5% reduction | >5%-10% reduction | >10%-15% reduction | >15%-20% reduction | >20%-25% reduction | >25%-30% reduction | >30%-35% reduction | >35%-40% reduction | >40%-45% reduction | >45%-50% reduction | >50%-55% reduction | >55%-60% reduction | >60%-65% reduction | >65%-70% reduction | >70%-75% reduction | >75%-80% reduction | >80%-85% reduction | >85%-90% reduction | >90%-95% reduction | >95%-100% reduction |
|---|
| Abscess, Placebo | 5 | 0 | 1 | 0 | 0 | 0 | 2 | 0 | 2 | 0 | 2 | 4 | 0 | 2 | 4 | 3 | 6 | 4 | 7 | 9 | 531 |
,| Abscess, TMP/SMX | 3 | 0 | 0 | 1 | 0 | 0 | 1 | 1 | 1 | 3 | 0 | 1 | 5 | 0 | 3 | 2 | 2 | 5 | 9 | 7 | 532 |
,| Cellulitis, Cephalexin | 5 | 0 | 0 | 1 | 0 | 0 | 1 | 1 | 0 | 1 | 0 | 2 | 2 | 2 | 3 | 2 | 2 | 2 | 6 | 7 | 188 |
,| Cellulitis, Cephalexin and TMP/SMX | 5 | 0 | 1 | 0 | 0 | 1 | 0 | 1 | 1 | 0 | 0 | 0 | 1 | 5 | 2 | 5 | 3 | 0 | 4 | 2 | 198 |
,| Infected Wound, Clindamycin | 3 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 2 | 1 | 2 | 1 | 4 | 4 | 2 | 208 |
,| Infected Wound, TMP/SMX | 3 | 0 | 0 | 1 | 0 | 1 | 1 | 0 | 0 | 3 | 1 | 2 | 1 | 3 | 2 | 3 | 2 | 1 | 2 | 5 | 197 |
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population
The area of erythema was measured in square centimeters at baseline and at the end-of-therapy visit. For each subject, the change in area was calculated as the area at end-of-therapy subtracted from the area at baseline. The change in area was then divided by the original area to determine the proportional change. Participants were then categorized by reductions in 5% intervals, with participants whose erythema did not change or increased categorized as no reduction. (NCT00729937)
Timeframe: Day 1 to Day 8-10
| Intervention | participants (Number) |
|---|
| No reduction | >0%-5% reduction | >5%-10% reduction | >10%-15% reduction | >15%-20% reduction | >20%-25% reduction | >25%-30% reduction | >30%-35% reduction | >35%-40% reduction | >40%-45% reduction | >45%-50% reduction | >50%-55% reduction | >55%-60% reduction | >60%-65% reduction | >65%-70% reduction | >70%-75% reduction | >75%-80% reduction | >80%-85% reduction | >85%-90% reduction | >90%-95% reduction | >95%-100% reduction |
|---|
| Abscess, Placebo | 4 | 0 | 1 | 0 | 0 | 0 | 2 | 0 | 2 | 0 | 2 | 4 | 0 | 1 | 4 | 3 | 6 | 4 | 7 | 9 | 478 |
,| Abscess, TMP/SMX | 3 | 0 | 0 | 1 | 0 | 0 | 1 | 1 | 1 | 3 | 0 | 1 | 5 | 0 | 3 | 2 | 2 | 5 | 7 | 7 | 478 |
,| Cellulitis, Cephalexin | 5 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 1 | 0 | 2 | 2 | 1 | 2 | 2 | 2 | 1 | 4 | 4 | 162 |
,| Cellulitis, Cephalexin and TMP/SMX | 5 | 0 | 1 | 0 | 0 | 1 | 0 | 1 | 1 | 0 | 0 | 0 | 1 | 5 | 2 | 5 | 2 | 0 | 4 | 1 | 183 |
,| Infected Wound, Clindamycin | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 2 | 1 | 0 | 1 | 3 | 4 | 1 | 182 |
,| Infected Wound, TMP/SMX | 3 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 2 | 1 | 2 | 1 | 3 | 2 | 3 | 2 | 1 | 1 | 3 | 167 |
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population
The area of erythema was measured in square centimeters at baseline and at the on-therapy visit. For each subject, the change in area was calculated as the area at on-therapy subtracted from the area at baseline. The change in area was then divided by the original area to determine the proportional change. Participants were then categorized by reductions in 5% intervals, with participants whose erythema did not change or increased categorized as no reduction. (NCT00729937)
Timeframe: Day 1 to Day 3-4
| Intervention | participants (Number) |
|---|
| No reduction | >0%-5% reduction | >5%-10% reduction | >10%-15% reduction | >15%-20% reduction | >20%-25% reduction | >25%-30% reduction | >30%-35% reduction | >35%-40% reduction | >40%-45% reduction | >45%-50% reduction | >50%-55% reduction | >55%-60% reduction | >60%-65% reduction | >65%-70% reduction | >70%-75% reduction | >75%-80% reduction | >80%-85% reduction | >85%-90% reduction | >90%-95% reduction | >95%-100% reduction |
|---|
| Abscess, Placebo | 67 | 3 | 2 | 3 | 2 | 7 | 12 | 13 | 12 | 20 | 13 | 14 | 12 | 15 | 21 | 18 | 17 | 20 | 20 | 15 | 298 |
,| Abscess, TMP/SMX | 43 | 2 | 4 | 3 | 7 | 5 | 6 | 8 | 15 | 17 | 15 | 7 | 11 | 24 | 10 | 20 | 22 | 20 | 16 | 16 | 328 |
,| Cellulitis, Cephalexin | 41 | 2 | 1 | 0 | 2 | 5 | 3 | 7 | 6 | 6 | 10 | 9 | 8 | 4 | 9 | 6 | 8 | 6 | 9 | 8 | 80 |
,| Cellulitis, Cephalexin and TMP/SMX | 34 | 1 | 6 | 5 | 5 | 4 | 5 | 4 | 6 | 9 | 5 | 4 | 9 | 16 | 7 | 11 | 9 | 11 | 6 | 6 | 74 |
,| Infected Wound, Clindamycin | 18 | 1 | 1 | 4 | 5 | 3 | 4 | 6 | 4 | 7 | 6 | 8 | 2 | 7 | 6 | 9 | 17 | 3 | 11 | 11 | 108 |
,| Infected Wound, TMP/SMX | 12 | 1 | 3 | 1 | 4 | 6 | 5 | 5 | 3 | 8 | 6 | 7 | 4 | 12 | 7 | 10 | 11 | 9 | 5 | 7 | 111 |
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population
The area of erythema was measured in square centimeters at baseline and at the on-therapy visit. For each subject, the change in area was calculated as the area at on-therapy subtracted from the area at baseline. The change in area was then divided by the original area to determine the proportional change. Participants were then categorized by reductions in 5% intervals, with participants whose erythema did not change or increased categorized as no reduction. (NCT00729937)
Timeframe: Day 1 to Day 3-4
| Intervention | participants (Number) |
|---|
| No reduction | >0%-5% reduction | >5%-10% reduction | >10%-15% reduction | >15%-20% reduction | >20%-25% reduction | >25%-30% reduction | >30%-35% reduction | >35%-40% reduction | >40%-45% reduction | >45%-50% reduction | >50%-55% reduction | >55%-60% reduction | >60%-65% reduction | >65%-70% reduction | >70%-75% reduction | >75%-80% reduction | >80%-85% reduction | >85%-90% reduction | >90%-95% reduction | >95%-100% reduction |
|---|
| Abscess, Placebo | 59 | 3 | 1 | 3 | 2 | 6 | 11 | 13 | 12 | 16 | 12 | 13 | 10 | 14 | 19 | 14 | 13 | 19 | 18 | 13 | 262 |
,| Abscess, TMP/SMX | 37 | 2 | 4 | 3 | 6 | 3 | 6 | 7 | 13 | 15 | 12 | 6 | 10 | 21 | 9 | 17 | 21 | 18 | 13 | 16 | 284 |
,| Cellulitis, Cephalexin | 33 | 2 | 1 | 0 | 2 | 4 | 3 | 7 | 2 | 6 | 9 | 6 | 8 | 3 | 7 | 5 | 7 | 6 | 8 | 6 | 67 |
,| Cellulitis, Cephalexin and TMP/SMX | 30 | 1 | 5 | 5 | 3 | 4 | 5 | 2 | 6 | 8 | 5 | 4 | 9 | 15 | 7 | 9 | 8 | 10 | 5 | 5 | 71 |
,| Infected Wound, Clindamycin | 17 | 1 | 0 | 3 | 5 | 2 | 3 | 5 | 3 | 6 | 6 | 6 | 2 | 6 | 5 | 7 | 16 | 3 | 8 | 10 | 89 |
,| Infected Wound, TMP/SMX | 11 | 1 | 3 | 1 | 4 | 5 | 5 | 4 | 3 | 7 | 5 | 6 | 4 | 12 | 6 | 8 | 6 | 8 | 4 | 5 | 87 |
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population
The area of erythema was measured in square centimeters at baseline and at the TOC visit. For each subject, the change in area was calculated as the area at TOC subtracted from the area at baseline. The change in area was then divided by the original area to determine the proportional change. Participants were then categorized by reductions in 5% intervals, with participants whose erythema did not change or increased categorized as no reduction. (NCT00729937)
Timeframe: Day 1 to Day 14-21
| Intervention | participants (Number) |
|---|
| No reduction | >0%-5% reduction | >5%-10% reduction | >10%-15% reduction | >15%-20% reduction | >20%-25% reduction | >25%-30% reduction | >30%-35% reduction | >35%-40% reduction | >40%-45% reduction | >45%-50% reduction | >50%-55% reduction | >55%-60% reduction | >60%-65% reduction | >65%-70% reduction | >70%-75% reduction | >75%-80% reduction | >80%-85% reduction | >85%-90% reduction | >90%-95% reduction | >95%-100% reduction |
|---|
| Abscess, Placebo | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 4 | 4 | 561 |
,| Abscess, TMP/SMX | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 2 | 1 | 1 | 559 |
,| Cellulitis, Cephalexin | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 217 |
,| Cellulitis, Cephalexin and TMP/SMX | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 2 | 1 | 1 | 0 | 0 | 220 |
,| Infected Wound, Clindamycin | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 219 |
,| Infected Wound, TMP/SMX | 1 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 1 | 216 |
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population
The area of erythema was measured in square centimeters at baseline and at the TOC visit. For each subject, the change in area was calculated as the area at TOC subtracted from the area at baseline. The change in area was then divided by the original area to determine the proportional change. Participants were then categorized by reductions in 5% intervals, with participants whose erythema did not change or increased categorized as no reduction. (NCT00729937)
Timeframe: Day 1 to Day 14-21
| Intervention | participants (Number) |
|---|
| No reduction | >0%-5% reduction | >5%-10% reduction | >10%-15% reduction | >15%-20% reduction | >20%-25% reduction | >25%-30% reduction | >30%-35% reduction | >35%-40% reduction | >40%-45% reduction | >45%-50% reduction | >50%-55% reduction | >55%-60% reduction | >60%-65% reduction | >65%-70% reduction | >70%-75% reduction | >75%-80% reduction | >80%-85% reduction | >85%-90% reduction | >90%-95% reduction | >95%-100% reduction |
|---|
| Abscess, Placebo | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 4 | 4 | 520 |
,| Abscess, TMP/SMX | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 1 | 1 | 516 |
,| Cellulitis, Cephalexin | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 189 |
,| Cellulitis, Cephalexin and TMP/SMX | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 2 | 1 | 1 | 0 | 0 | 207 |
,| Infected Wound, Clindamycin | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 199 |
,| Infected Wound, TMP/SMX | 1 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 191 |
Duration of Treatment
(NCT00473083)
Timeframe: Up to one year
| Intervention | months (Median) |
|---|
| Arm 1: Prophylactic Treatment | 3.6 |
| Arm 2: Reactive Treatment | 1.8 |
| Arm 3: No Treatment Unless Severe (Grade 3) | 1.8 |
Overall Incidence of Grade 3 Rash
"The overall incidence of grade 3 erlotinib-induced rash among the three treatment arms.~For overall incidence of rash a binary variable will be designed. Data will be summarized with percentages by treatment group." (NCT00473083)
Timeframe: From onset of rash until resolution, up to 4 weeks following progression, on average of 1 year
| Intervention | percentage of participants (Number) |
|---|
| Arm 1: Prophylactic Treatment | 14.3 |
| Arm 2: Reactive Treatment | 9.5 |
| Arm 3: No Treatment Unless Severe (Grade 3) | 34.1 |
Overall Incidence of Rash
"The overall incidence of any grade of erlotinib-induced rash among the three treatment arms.~For overall incidence of rash a binary variable will be designed. Data will be summarized with percentages by treatment group." (NCT00473083)
Timeframe: From onset of rash until resolution, up to 4 weeks following progression, an average of 1 year
| Intervention | percentage of participants (Number) |
|---|
| Arm 1: Prophylactic Treatment | 84 |
| Arm 2: Reactive Treatment | 84 |
| Arm 3: No Treatment Unless Severe (Grade 3) | 82 |
Overall Survival
(NCT00473083)
Timeframe: Until death
| Intervention | months (Median) |
|---|
| Arm 1: Prophylactic Treatment | 7.6 |
| Arm 2: Reactive Treatment | 8.0 |
| Arm 3: No Treatment Unless Severe (Grade 3) | 6.0 |
Time to First Presentation of Rash
(NCT00473083)
Timeframe: Up to onset of rash while on study treatment
| Intervention | days (Mean) |
|---|
| Arm 1: Prophylactic Treatment | 17.4 |
| Arm 2: Reactive Treatment | 13.3 |
| Arm 3: No Treatment Unless Severe (Grade 3) | 12.0 |
Severity of Rash Caused by Erlotinib
The maximum severity of rash per subject will be summarized by treatment group. The summary will include only subjects who indicated any occurrence of rash. (NCT00473083)
Timeframe: Onset until resolution, up to 4 weeks following progression, on average of 1 year
| Intervention | percentage of participants (Number) |
|---|
| Maximal Rash Grade 1 | Maximal Rash Grade 2a | Maximal Rash Grade 2b | Maximal Rash Grade 3 |
|---|
| Arm 1: Prophylactic Treatment | 40.5 | 26.2 | 19.0 | 14.3 |
,| Arm 2: Reactive Treatment | 47.6 | 33.3 | 9.5 | 9.5 |
,| Arm 3: No Treatment Unless Severe (Grade 3) | 46.3 | 14.6 | 4.9 | 34.1 |
Time Duration From Onset of Rash Until Resolution
"To investigate if the rash caused by erlotinib is self-limiting.~A time variable will be defined to identify the duration from onset of rash until resolution. Resolution will be defined as resolution to severity Grade 1 for patients with rash of maximum severity grade >1 and resolution to Grade 0 for patients with maximum rash severity = 1. For patients where resolution is not observed the time considered will be the maximum time from onset of rash until end of the study.~The analyses will be performed using the following two sub-populations: subjects with maximum severity of rash of Grade 1, 2a and 2b will constitute one sub-population and Grade 3 will be considered the second sub-population.~The comparisons will be performed primarily for Group 1 vs. Group 3 and Group 2 vs. Group 3 and secondly for Group 1 vs. Group 2." (NCT00473083)
Timeframe: From onset of rash until resolution, up to 4 weeks following progression, an average of 1 year
| Intervention | days (Median) |
|---|
| Patients With Max Severity of Rash Gr 1, 2a and 2b | Patients With Maximum Severity of Rash Grade 3 |
|---|
| Arm 1: Prophylactic Treatment | 133.0 | 201.0 |
,| Arm 2: Reactive Treatment | 92.0 | 76.0 |
,| Arm 3: No Treatment Unless Severe (Grade 3) | 98.0 | 54.0 |
Birthweight
Median birthweight (NCT01114516)
Timeframe: 24 weeks
| Intervention | grams (Median) |
|---|
| Control | 2488 |
| Indomethacin and Antibiotics | 2850 |
Gestational Age at Delivery
Median gestational age at delivery (NCT01114516)
Timeframe: 24 weeks
| Intervention | weeks (Median) |
|---|
| Control | 31.1 |
| Indomethacin and Antibiotics | 34.8 |
Gestational Latency Achieved Between Cerclage Placement and Time of Delivery
Median gestational latency achieved Between Cerclage Placement and Time of Delivery (NCT01114516)
Timeframe: 24 weeks
| Intervention | days (Median) |
|---|
| Control | 80 |
| Indomethacin and Antibiotics | 97 |
Gestational Latency of More Than 28 Days
The frequency of achieving a gestational latency of more than 28 days (NCT01114516)
Timeframe: 28 days postpartum
| Intervention | percentage of participants (Number) |
|---|
| Control | 62.5 |
| Indomethacin and Antibiotics | 92.3 |
Neonatal Morbidity and Mortality
Days spent in the neonatal intensive care unit (NCT01114516)
Timeframe: 1 year
| Intervention | days (Median) |
|---|
| Control | 95 |
| Indomethacin and Antibiotics | 43 |
Sebum Measurements
To sample the skin surface, the sebum collector strips are applied to the skin sites for 10 seconds. Once removed, these samples will be immediately measured for the amount of sebum on the strip using the tape analyzer. The amount of sebum production was measured as the amount of sebum collected on a tape applied to the skin for 10 seconds and then converted to 1 of 10 incremental levels. Sebum production was measured in increments of 0 (minimum value) to 10 (maximum value). The higher the number, the greater amount of sebum produced. (NCT00964366)
Timeframe: 2 weeks
| Intervention | units on a scale (Mean) |
|---|
| Baseline | Day 3 | Day 7 | Day 14 |
|---|
| Clindamycin and BPO Gel | 1.72 | 1.52 | 2.65 | 2.35 |
,| Dapsone Gel | 2.18 | 1.72 | 3.33 | 2.38 |
Skin Dryness
"The amount of dryness on the left and right cheek of each panelist.~The scale used to evaluate skin dryness is:~Grade Description 0 None 2 Slight flaking 4 Moderate flaking/scaling 6 Marked scaling / slight fissuring 8 Severe scaling, fissuring~Expert Grader assessments of dryness were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14." (NCT00964366)
Timeframe: Baseline, Day 1through Day 14
| Intervention | Units on a scale (Mean) |
|---|
| Baseline | Day 1 | Day 2 | Day 3 | Day 6 | Day 7 | Day 8 | Day 9 | Day 10 | Day 13 | Day 14 |
|---|
| Clindamycin and BPO Gel | 0.11 | 0.04 | 0.10 | 0.16 | 0.27 | 0.21 | 0.54 | 0.5 | 0.57 | 0.57 | 0.55 |
,| Dapsone Gel | 0.12 | 0.28 | 0.23 | 0.48 | 0.37 | 0.23 | 0.17 | 0.10 | 0.15 | 0.17 | 0.12 |
Skin Erythema (Redness)
"Assessment of erythema as part of an evaluation of tolerance of two treatments: clindamycin and benzoyl peroxide or dapsone gel. This was done by visual assessment by an independent blinded grader using the grading scale shown below.~Grade Description 0 None 2 Mild erythema 4 Moderate confluent erythema 6 Marked erythema with some edema 8 Marked erythema, edema, possible erosion" (NCT00964366)
Timeframe: 2 Weeks
| Intervention | Units on a scale (Mean) |
|---|
| Baseline | Day 1 | Day 2 | Day 3 | Day 6 | Day 7 | Day 8 | Day 9 | Day 10 | Day 13 | Day 14 |
|---|
| Clindamycin and BPO Gel | 1.06 | 1.26 | 1.55 | 1.32 | 1.30 | 1.64 | 1.80 | 1.67 | 1.81 | 1.52 | 2.10 |
,| Dapsone Gel | 1.18 | 1.34 | 1.33 | 1.50 | 1.65 | 1.53 | 1.60 | 1.45 | 1.85 | 1.65 | 1.90 |
Skin Hydration
Evaluation of Skin Hydration using electrical conductance measurements,on weekdays during 14 days of treatment. The value recorded which is expressed in units of microsiemens represents the AC conductance 2-3 seconds after placing the spring-loaded probe tip to the sample site. (NCT00964366)
Timeframe: 2 weeks
| Intervention | Microsiemens (Mean) |
|---|
| Baseline | 4 hours post 1st treatment | Day 3 | Day 7 | Day 14 |
|---|
| Clindamycin and BPO Gel | 499.51 | 430.38 | 614.73 | 460.65 | 477.80 |
,| Dapsone Gel | 448.31 | 404.68 | 511.63 | 456.73 | 471.13 |
Transepidermal Water Loss (TEWL)
To assess skin moisture and hydration using transepidermal water loss (TEWL). These tables record the data obtained for each panelist at Baseline, and on Days 3, 7 and 14 or upon early termination of site(s), if applicable. Results are measured on a continuous scale. (NCT00964366)
Timeframe: 2 Weeks
| Intervention | TEWL rates (gm/m2/hr) (Mean) |
|---|
| Baseline | Day 3 | Day 7 | Day 14 |
|---|
| Clindamycin and BPO Gel | 10.29 | 12.34 | 14.39 | 13.88 |
,| Dapsone Gel | 10.4 | 11.21 | 11.53 | 11.26 |
Number of Subjects With Positive Bacterial Growth Culture Per Treatment Arms
Detected presence of growth of Propionibacterium acnes on bacterial culture (bacteria per mL) by treatment arms. (NCT03257202)
Timeframe: 21 days
| Intervention | participants (Number) |
|---|
| Negative Control | 10 |
| Benzoyl Peroxide 5% Topical Gel | 12 |
| Clindamycin 1% Topical Gel | 10 |
| Clindamycin 1% Plus Benzoyl Peroxide 5% Topical Gel | 10 |
Number of Participant With Clinical Success on the Investigator's Global Assessment (IGA)
Clinical success was defined as a score of clear (0) or almost clear (1) at Week 10. (NCT01138514)
Timeframe: 10 weeks
| Intervention | participants (Number) |
|---|
| Clindamycin 1%/Benzoyl Peroxide 5% | 247 |
| Reference Product | 234 |
| Vehicle | 79 |
Percent Change From Baseline in Inflammatory Lesions
(NCT01138514)
Timeframe: 10 weeks
| Intervention | percentage of lesion reduction (Mean) |
|---|
| Clindamycin 1%/Benzoyl Peroxide 5% | 79.87 |
| Reference Product | 80.86 |
| Vehicle | 45.60 |
Percent Change From Baseline in Non-inflammatory Lesions
(NCT01138514)
Timeframe: 10 weeks
| Intervention | percentage of lesion reduction (Mean) |
|---|
| Clindamycin 1%/Benzoyl Peroxide 5% | 70.21 |
| Reference Product | 70.02 |
| Vehicle | 36.16 |
Mean Percent Change From Baseline in Inflammatory (Papules and Pustules) Lesions
(NCT02515305)
Timeframe: Baseline to Day 84
| Intervention | percentage of lesion change (Mean) |
|---|
| Test Product | 71.05 |
| Reference Product | 72.84 |
| Placebo Product | 51.53 |
Mean Percent Change From Baseline in Non-inflammatory (Open and Closed Comedones) Lesions
(NCT02515305)
Timeframe: Baseline to Day 84
| Intervention | percentage of lesion change (Mean) |
|---|
| Test Product | 58.99 |
| Reference Product | 58.93 |
| Placebo Product | 32.25 |
Percent Change From Baseline in Inflammatory Lesion Counts at Week 12
Percent Change from baseline in inflammatory lesion counts (papules, pustules and nodules) at week 12. Papules and nodules are round, solid elevations of the skin with no visible fluid; papules are smaller (less than 5 or 10 millimeters in width and depth) and nodules are larger (greater than 5 or 10 millimeters in width and depth). Pustules are small elevations of the skin containing cloudy material. A negative number change from baseline indicates a reduction in lesion counts (improvement). (NCT01231334)
Timeframe: Baseline, Week 12
| Intervention | Percent change (Median) |
|---|
| Aczone® Gel 5% Plus Differin® 0.3% Gel | -70.7 |
| Duac® Topical Gel Plus Differin® 0.3% Gel | -75.9 |
Percent Change From Baseline in Non-inflammatory Lesion Counts at Week 12
"Percent Change from baseline in non-inflammatory lesion counts (open/closed comedones) at week 12. Comedones are small bumps on the skin (lesions) caused by acne and found at the opening of a skin pore. Open comedones (also known as a blackheads) have a microscopic opening to the skin surface, while closed comedones (also known as whiteheads or pimples) lack the opening to the skin. A negative number change from baseline indicates a reduction in lesion counts (improvement)." (NCT01231334)
Timeframe: Baseline, Week 12
| Intervention | Percent change (Median) |
|---|
| Aczone® Gel 5% Plus Differin® 0.3% Gel | -55.3 |
| Duac® Topical Gel Plus Differin® 0.3% Gel | -60.7 |
Percent Change From Baseline in Total Lesion Count at Week 12
Percent change in total lesion counts: inflammatory (papules, pustules and nodules) and non-inflammatory (comedones) lesion counts from baseline. Papules and nodules are round, solid elevations of the skin with no visible fluid; papules are smaller (less than 5 or 10 millimeters ) and nodules are larger (greater than 5 or 10 millimeters). Pustules are small elevations of the skin containing cloudy material. Comedones are small bumps on the skin caused by acne and found at the opening of a skin pore. A negative change from baseline indicates a reduction in lesion counts (improvement). (NCT01231334)
Timeframe: Baseline, Week 12
| Intervention | Percent change (Median) |
|---|
| Aczone® Gel 5% Plus Differin® 0.3% Gel | -62.7 |
| Duac® Topical Gel Plus Differin® 0.3% Gel | -65.0 |
Percentage of Participants at Week 12 Having at Least a One Point Decrease in Overall Disease Severity
The overall disease severity was evaluated by the investigator at Baseline and Week 12 using a 7-point scale to rate the overall acne severity (lesions, inflammation, facial redness and skin condition), where 0=no acne lesions and 6=most severe acne. The percentage of participants with at least a one point decrease (improvement) from baseline is calculated. (NCT01231334)
Timeframe: Baseline, Week 12
| Intervention | Percentage of participants (Number) |
|---|
| Aczone® Gel 5% Plus Differin® 0.3% Gel | 83.5 |
| Duac® Topical Gel Plus Differin® 0.3% Gel | 92.4 |
Percentage of Participants With at Least a One Point Decrease in the Global Acne Assessment Score (GAAS) at Week 12
GAAS was conducted by the investigator at Baseline and Week 12. The patient's facial acne was evaluated on a 5 point scale 0=None (no evidence of acne), 1=Minimal (few lesions), 2=Mild (several to many non-inflammatory lesions; few inflammatory lesions), 3=Moderate (many lesions) to 4=Severe (Significant degree of inflammatory disease; papules/pustules present, few nodulo-cystic lesions; comedones may be present). Papules/nodules are round, solid elevations of the skin with no visible fluid. The percentage of participants with at least a one point decrease (improvement) in GAAS was calculated. (NCT01231334)
Timeframe: Baseline, Week 12
| Intervention | Percentage of participants (Number) |
|---|
| Aczone® Gel 5% Plus Differin® 0.3% Gel | 69.7 |
| Duac® Topical Gel Plus Differin® 0.3% Gel | 81.4 |
Change From Baseline in Global Acne Assessment Score (GAAS) at Week 12
GAAS was conducted by the investigator. The patient's facial acne was evaluated on a 5 point scale 0=None (no evidence of acne), 1=Minimal (few lesions), 2=Mild (several to many non-inflammatory lesions; few inflammatory lesions), 3=Moderate (many lesions) to 4=Severe (Significant degree of inflammatory disease; papules/pustules present, few nodulo-cystic lesions; comedones may be present). Papules and nodules are round, solid elevations of the skin with no visible fluid. A negative change from baseline indicates improvement. (NCT01231334)
Timeframe: Baseline, Week 12
| Intervention | Score on a scale (Mean) |
|---|
| Baseline | Change from baseline at Week 12 |
|---|
| Aczone® Gel 5% Plus Differin® 0.3% Gel | 2.80 | -0.87 |
,| Duac® Topical Gel Plus Differin® 0.3% Gel | 2.84 | -1.27 |
Percentage of Participants Demonstrating a ≥ 1 Category Increase in Tolerability From Baseline at Week 12
The investigator rated the patient's current symptoms of erythema, dryness, peeling, and oiliness on a 5 point scale from 0 (Absent) to 4 (Severe). The investigator rated the symptoms of pruritus and burning since last visit on a 6 point scale of 0 (Absent) to 5 (Severe)-interfering with daily activities. Percentage of participants demonstrating a ≥1 category increase (improvement) in tolerability from baseline is calculated. (NCT01231334)
Timeframe: Baseline, Week 12
| Intervention | Percentage of participants (Number) |
|---|
| Dryness | Peeling | Oiliness | Erythema | Pruritus | Burning |
|---|
| Aczone® Gel 5% Plus Differin® 0.3% Gel | 21.3 | 11.5 | 6.7 | 8.2 | 12.4 | 13.2 |
,| Duac® Topical Gel Plus Differin® 0.3% Gel | 11.9 | 9.3 | 6.0 | 6.8 | 8.5 | 12.7 |
Change in the Level of Lactobacillus in Vaginal Flora Determined by Vaginal Cultures.
Lactobacillus spp count. in vaginal discharge at baseline and at visit 1, determined by vaginal cultures. (NCT02860845)
Timeframe: Baseline and 2 weeks after treatment finalization
| Intervention | Count of Organism/counting chamber (Mean) |
|---|
| Boric Acid and Probiotics Baseline | 51.59 |
| Antibiotic/Antifungal Baseline | 49.30 |
| Boric Acid and Probiotics Visit 1 | 81.82 |
| Antibiotic/Antifungal Visit 1 | 66.09 |
Change in the Presence of Vaginitis Clinical Symptoms Determined by Sobel Score.
Semi-quantitative scale where itching, erythema, edema, stinging and abnormal vaginal discharge are scored from 0 to 3: absent (0), mild (1), moderate (2), severe (3). Worse result is 3 (severe) (NCT02860845)
Timeframe: Baseline and at 2 weeks after treatment finalization
| Intervention | score on a scale (Mean) |
|---|
| Stinging sobel score | Itching Sobel Score | Erythema Sobel Score | Edema Sobel Score | abnormal vaginal discharge |
|---|
| Antibiotic/Antifungal Baseline | 1.21 | 1.58 | 0.96 | 0.42 | 1.96 |
,| Antibiotic/Antifungal Visit 1 | 0.22 | 0.57 | 0.17 | 0 | 0.35 |
,| Boric Acid and Probiotics Baseline | 1.13 | 1.63 | 0.92 | 0.5 | 1.67 |
,| Boric Acid and Probiotics Visit 1 | 0.18 | 0.41 | 0.14 | 0.05 | 0.23 |
Number of Participants With Recurrent Infections
Descriptive of the proportion of patients with vulvovaginitis recurrence (NCT02860845)
Timeframe: At 3 months after recruitment
| Intervention | Participants (Count of Participants) |
|---|
| No recurrence | Recurrence |
|---|
| Antibiotic/Antifungal | 14 | 9 |
,| Boric Acid and Probiotics | 17 | 5 |
Death
Number of Participants who experienced Death (NCT01994993)
Timeframe: Within 30 days after last dose of study drug, up to 40 days
| Intervention | Participants (Count of Participants) |
|---|
| Group 1 | 5 |
| Group 2 | 5 |
| Group 3 | 7 |
| Group 4 | 1 |
| Group 5 | 0 |
Number of Participants Progressed to a Higher Stage of Necrotizing Enterocolitis (NEC), if NEC is the Cause of the Complicated Intra-abdominal Infection
Progression is determined by the clinical NEC scoring (NCT01994993)
Timeframe: 90 days after last dose of study drug
| Intervention | Participants (Count of Participants) |
|---|
| Group 1 | 1 |
| Group 2 | 2 |
| Group 3 | 0 |
| Group 4 | 1 |
Number of Participants With Feeding Intolerance
Feeding intolerance confirmed by documentation of any feedings held for >24 consecutive hours in infants being fed (NCT01994993)
Timeframe: 90 days after last dose of study drug
| Intervention | Participants (Count of Participants) |
|---|
| Group 1 | 24 |
| Group 2 | 19 |
| Group 3 | 21 |
| Group 4 | 18 |
Number of Participants With Gastrointestinal Surgeries
Determined by medical history and confirmed with hospital records. (Laparotomy) (NCT01994993)
Timeframe: 90 days after last dose of study drug
| Intervention | Participants (Count of Participants) |
|---|
| Group 1 | 27 |
| Group 2 | 15 |
| Group 3 | 26 |
| Group 4 | 10 |
Number of Participants With Grade 3 and/or Grade 4 Intraventricular Hemorrhage (IVH)
"Grade 3 IVH: Subependymal hemorrhage with extension into lateral ventricles with ventricular enlargement~Grade 4 IVH: Intraparenchymal hemorrhage" (NCT01994993)
Timeframe: 90 days after last dose of study drug
| Intervention | Participants (Count of Participants) |
|---|
| Group 1 | 2 |
| Group 2 | 4 |
| Group 3 | 4 |
| Group 4 | 0 |
Number of Participants With Intestinal Perforation
"Intestinal perforation: Radiological reports leading to the diagnosis of intestinal perforation. These include plain chest x-rays, plain abdominal x-rays, ultra-sonograms of the abdomen, contrast studies, and computed tomography scans of the abdomen and pelvis.~Operative reports documenting surgical procedures leading to the diagnosis and/or treatment of intestinal perforation. These include placement of a surgical drain, laparotomy, intestinal resection, and ostomy placement" (NCT01994993)
Timeframe: 90 days after last dose of study drug
| Intervention | Participants (Count of Participants) |
|---|
| Group 1 | 2 |
| Group 2 | 4 |
| Group 3 | 2 |
| Group 4 | 1 |
Number of Participants With Intestinal Stricture
"Intestinal stricture: Radiology reports leading to the diagnosis of intestinal stricture. These include plain abdominal x-rays, upper gastrointestinal series with small bowel follow-through, contrast enema studies, and computed tomography scans of the abdomen and pelvis.~Operative reports documenting surgical procedures leading to the diagnosis and/or treatment of intestinal stricture. These procedures include endoscopy, laparotomy, stricture dilatation, intestinal resection, and ostomy placement" (NCT01994993)
Timeframe: 90 days after last dose of study drug
| Intervention | Participants (Count of Participants) |
|---|
| Group 1 | 3 |
| Group 2 | 2 |
| Group 3 | 4 |
| Group 4 | 1 |
Number of Participants With Positive Blood Cultures
Positive blood culture (bacterial or fungal) (NCT01994993)
Timeframe: 90 days after last dose of study drug
| Intervention | Participants (Count of Participants) |
|---|
| Group 1 | 8 |
| Group 2 | 4 |
| Group 3 | 12 |
| Group 4 | 5 |
Number of Participants With Seizure
documented seizure(s) in hospital records (NCT01994993)
Timeframe: 90 days after last dose of study drug
| Intervention | Participants (Count of Participants) |
|---|
| Group 1 | 4 |
| Group 2 | 0 |
| Group 3 | 2 |
| Group 4 | 1 |
Number of Participants With Short Bowel Syndrome
"Short bowel syndrome: Operative reports documenting resection of bowel, estimated bowel length, and absence/presence of the ileocecal valve.~Total parenteral nutrition for >42 consecutive days after bowel resection, or a residual small bowel length of less than 25% expected for gestational age" (NCT01994993)
Timeframe: 90 days after last dose of study drug
| Intervention | Participants (Count of Participants) |
|---|
| Group 1 | 5 |
| Group 2 | 3 |
| Group 3 | 1 |
| Group 4 | 1 |
Number of Participants With Therapeutic Success at Day 30
"Confirmed by 1).Alive, 2).Negative bacterial blood cultures, and 3). Clinical cure score >4.~Clinical cure score =1 for each of the following elements:~FiO2 ≤ baseline FiO2; Urine output ≥1 mL/kg/h for 24-hour period prior to assessment; Absence of inotropic support at time of assessment; Absence of mechanical ventilation at time of assessment; No seizure in 24-hour period prior to assessment; pH ≥7.25 or not measured in 24 hours prior to assessment" (NCT01994993)
Timeframe: 30 days after last dose of study drug
| Intervention | Participants (Count of Participants) |
|---|
| Group 1 | 45 |
| Group 2 | 39 |
| Group 3 | 52 |
| Group 4 | 52 |
Half-life
"In order to understand the impact of obesity on clindamycin PK, PK data were combined to build a PK model from 3 studies that included both obese and non-obese children: 1) PTN_Clinda Obese study (clinicaltrials.gov/ct.gov identifier NCT01744730) n = 21; 2) PTN_POPS study (ct.gov identifier NCT01431326) n = 178; and 3) Staph Trio study (ct.gov identifier NCT01728363) n = 21. The data from the Staph-Trio study were only included for PK modeling and not intended to be compared in the analysis.~PK sampling schedule for PTN_Clinda Obese was: Pre-dose 0 (within 15 minutes prior to IV clindamycin dose), 0.5 (± 5 minutes) after dose was administered, 1-1.5 hours (hrs) after dose, 3-4 hrs after, 5-6 hrs after, and pre-next dose. Samples were collected on multiple days and averaged to arrive at a single value. Comparison of empirical Bayesian Estimates (EBE) for half-life by age cohort are presented below.~Sampling schedule details for PTN_POPS and Staph Trio were comparable." (NCT01744730)
Timeframe: After participant transitioned from IV Clindamycin to oral Clindamycin through Day 14 (minimum of 3 samples; maximum of 6 samples).
| Intervention | hours (Median) |
|---|
| Clindamycin- Ages >2 to 6 Years Old (Non-Obese) | 2.4 |
| Clindamycin- Ages >2 to 6 Years Old (Obese) | 2.2 |
| Clindamycin- Ages >6 to 12 Years Old (Non-Obese) | 2.2 |
| Clindamycin- Ages >6 to 12 Years Old (Obese) | 3.0 |
| Clindamycin- Age >12 Years Old (Non-Obese) | 2.8 |
| Clindamycin- Age >12 Years Old (Obese) | 3.6 |
Pharmacokinetics (PK) - Clearance (Cl) in Participants Who Received Multiple Doses of Intravenous (IV) Clindamycin.
"In order to understand the impact of obesity on clindamycin PK, PK data were combined to build a PK model from 3 studies that included both obese and non-obese children: 1) PTN_Clinda Obese study (clinicaltrials.gov/ct.gov identifier NCT01744730) n = 21; 2) PTN_POPS study (ct.gov identifier NCT01431326) n = 178; and 3) Staph Trio study (ct.gov identifier NCT01728363) n = 21. The data from the Staph-Trio study were only included for PK modeling and not intended to be compared in the analysis.~PK sampling schedule for PTN_Clinda Obese was: Pre-dose 0 (within 15 minutes prior to IV clindamycin dose), 0.5 (± 5 minutes) after dose was administered, 1-1.5 hours (hrs) after dose, 3-4 hrs after, 5-6 hrs after, and pre-next dose. Samples were collected on multiple days and averaged to arrive at a single value. Comparison of EBE for clearance by age cohort normalized to 1 kg of body weight are presented below.~Sampling schedule details for PTN_POPS and Staph Trio were comparable." (NCT01744730)
Timeframe: After first study dose of IV Clindamycin through Day 14 (minimum of 3 samples; maximum of 6 samples).
| Intervention | L/h/kg (Median) |
|---|
| Clindamycin- Ages >2 to 6 Years Old (Non-Obese) | 0.2 |
| Clindamycin- Ages >2 to 6 Years Old (Obese) | 0.3 |
| Clindamycin- Ages >6 to 12 Years Old (Non-Obese) | 0.3 |
| Clindamycin- Ages >6 to 12 Years Old (Obese) | 0.2 |
| Clindamycin- Age >12 Years Old (Non-Obese) | 0.2 |
| Clindamycin- Age >12 Years Old (Obese) | 0.2 |
Pharmacokinetics (PK) - Clearance (Cl) in Participants Who Received Multiple Doses of Intravenous (IV) Clindamycin.
"In order to understand the impact of obesity on clindamycin PK, PK data were combined to build a PK model from 3 studies that included both obese and non-obese children: 1) PTN_Clinda Obese study (clinicaltrials.gov/ct.gov identifier NCT01744730) n = 21; 2) PTN_POPS study (ct.gov identifier NCT01431326) n = 178; and 3) Staph Trio study (ct.gov identifier NCT01728363) n = 21. The data from the Staph-Trio study were only included for PK modeling and not intended to be compared in the analysis.~PK sampling schedule for PTN_Clinda Obese was: Pre-dose 0 (within 15 minutes prior to IV clindamycin dose), 0.5 (± 5 minutes) after dose was administered, 1-1.5 hours (hrs) after dose, 3-4 hrs after, 5-6 hrs after, and pre-next dose. Samples were collected on multiple days and averaged to arrive at a single value. Comparison of EBE for clearance by age cohort normalized to 70 kg of body weight are presented below.~Sampling schedule details for PTN_POPS and Staph Trio were comparable." (NCT01744730)
Timeframe: After first study dose of IV Clindamycin through Day 14 (minimum of 3 samples; maximum of 6 samples).
| Intervention | L/h/70 kg (Median) |
|---|
| Clindamycin- Ages >2 to 6 Years Old (Non-Obese) | 10.6 |
| Clindamycin- Ages >2 to 6 Years Old (Obese) | 14.8 |
| Clindamycin- Ages >6 to 12 Years Old (Non-Obese) | 20.7 |
| Clindamycin- Ages >6 to 12 Years Old (Obese) | 14.7 |
| Clindamycin- Age >12 Years Old (Non-Obese) | 15.8 |
| Clindamycin- Age >12 Years Old (Obese) | 14 |
Pharmacokinetics (PK) - Clearance (Cl) in Participants Who Received Multiple Doses of Intravenous (IV) Clindamycin.
"In order to understand the impact of obesity on clindamycin PK, PK data were combined to build a PK model from 3 studies that included both obese and non-obese children: 1) PTN_Clinda Obese study (clinicaltrials.gov/ct.gov identifier NCT01744730) n = 21; 2) PTN_POPS study (ct.gov identifier NCT01431326) n = 178; and 3) Staph Trio study (ct.gov identifier NCT01728363) n = 21. The data from the Staph-Trio study were only included for PK modeling and not intended to be compared in the analysis.~PK sampling schedule for PTN_Clinda Obese was: Pre-dose 0 (within 15 minutes prior to IV clindamycin dose), 0.5 (± 5 minutes) after dose was administered, 1-1.5 hours (hrs) after dose, 3-4 hrs after, 5-6 hrs after, and pre-next dose. Samples were collected on multiple days and averaged to arrive at a single value. Comparison of empirical Bayesian Estimates (EBE) for clearance by age cohort are presented below.~Sampling schedule details for PTN_POPS and Staph Trio were comparable." (NCT01744730)
Timeframe: After first study dose of IV Clindamycin through Day 14 (minimum of 3 samples; maximum of 6).
| Intervention | L/h (Median) |
|---|
| Clindamycin- Ages >2 to 6 Years Old (Non-Obese) | 4.2 |
| Clindamycin- Ages >2 to 6 Years Old (Obese) | 5.7 |
| Clindamycin- Ages >6 to 12 Years Old (Non-Obese) | 12.5 |
| Clindamycin- Ages >6 to 12 Years Old (Obese) | 10.7 |
| Clindamycin- Age >12 Years Old (Non-Obese) | 14.3 |
| Clindamycin- Age >12 Years Old (Obese) | 19.2 |
PK - Volume of Distribution (V) in Participants Who Received Multiple Doses of Intravenous (IV) Clindamycin.
"In order to understand the impact of obesity on clindamycin PK, PK data were combined to build a PK model from 3 studies that included both obese & non-obese children: 1) PTN_Clinda Obese study (clinicaltrials.gov/ct.gov identifier NCT01744730) n = 21; 2) PTN_POPS study (ct.gov identifier NCT01431326) n = 178; and 3) Staph Trio study (ct.gov identifier NCT01728363) n = 21. The data from the Staph-Trio study were only included for PK modeling and not intended to be compared in the analysis.~PK sampling schedule for PTN_Clinda Obese was: Pre-dose 0 (within 15 minutes prior to IV clindamycin dose), 0.5 (± 5 minutes) after dose was administered, 1-1.5 hours (hrs) after dose, 3-4 hrs after, 5-6 hrs after, and pre-next dose. Samples were collected on multiple days and averaged to arrive at a single value. Comparison of EBE for volume of distribution by age cohort normalized to 1kg of body weight are presented below.~Sampling schedule details for PTN_POPS & Staph Trio were comparable." (NCT01744730)
Timeframe: After first study dose of IV Clindamycin through Day 14 (minimum of 3 samples; maximum of 6 samples).
| Intervention | L/kg (Median) |
|---|
| Clindamycin- Ages >2 to 6 Years Old (Non-Obese) | 0.8 |
| Clindamycin- Ages >2 to 6 Years Old (Obese) | 0.9 |
| Clindamycin- Ages >6 to 12 Years Old (Non-Obese) | 0.9 |
| Clindamycin- Ages >6 to 12 Years Old (Obese) | 1.0 |
| Clindamycin- Age >12 Years Old (Non-Obese) | 0.9 |
| Clindamycin- Age >12 Years Old (Obese) | 0.9 |
PK - Volume of Distribution (V) in Participants Who Received Multiple Doses of Intravenous (IV) Clindamycin.
"In order to understand the impact of obesity on clindamycin PK, PK data were combined to build a PK model from 3 studies that included both obese and non-obese children: 1) PTN_Clinda Obese study (clinicaltrials.gov/ct.gov identifier NCT01744730) n = 21; 2) PTN_POPS study (ct.gov identifier NCT01431326) n = 178; and 3) Staph Trio study (ct.gov identifier NCT01728363) n = 21. The data from the Staph-Trio study were only included for PK modeling and not intended to be compared in the analysis.~PK sampling schedule for PTN_Clinda Obese was: Pre-dose 0 (within 15 minutes prior to IV clindamycin dose), 0.5 (± 5 minutes) after dose was administered, 1-1.5 hours (hrs) after dose, 3-4 hrs after, 5-6 hrs after, and pre-next dose. Samples were collected on multiple days and averaged to arrive at a single value. Comparison of EBE for volume of distribution by age cohort are presented below.~Sampling schedule details for PTN_POPS and Staph Trio were comparable." (NCT01744730)
Timeframe: After first study dose of IV Clindamycin through Day 14 (minimum of 3 samples; maximum of 6 samples).
| Intervention | L (Median) |
|---|
| Clindamycin- Ages >2 to 6 Years Old (Non-Obese) | 15.3 |
| Clindamycin- Ages >2 to 6 Years Old (Obese) | 17.6 |
| Clindamycin- Ages >6 to 12 Years Old (Non-Obese) | 29.0 |
| Clindamycin- Ages >6 to 12 Years Old (Obese) | 46.9 |
| Clindamycin- Age >12 Years Old (Non-Obese) | 60.1 |
| Clindamycin- Age >12 Years Old (Obese) | 85.8 |
Percent Change in the Non-inflammatory (Open and Closed Comedones) Lesion Counts - Change in Baseline to 12 Week
(NCT03522441)
Timeframe: Percent change in baseline to 12 weeks
| Intervention | percent change from baseline (Mean) |
|---|
| Clindamycin 1% Gel (Akorn Pharmaceuticals) | -50.45 |
| Clindamycin 1% Gel (Greenstone LLC) | -57.42 |
| Placebo | -46.07 |
Percent Change in the Number of Inflamed Lesions (Papules/Pustules)- Time Frame: Baseline to 12 Weeks
(NCT03522441)
Timeframe: Percent change from baseline to 12 weeks
| Intervention | % mean change from baseline (Mean) |
|---|
| Clindamycin 1% Gel (Akorn Pharmaceuticals) | -66.22 |
| Clindamycin 1% Gel (Greenstone LLC) | -72 |
| Placebo | -16.02 |
Adverse Event Rates
Outcome is reported as a patient self report of adverse events over 10 weeks. (NCT02730962)
Timeframe: 10 weeks
| Intervention | Number of adverse events (Number) |
|---|
| Antibiotics Prior to FMT | 6 |
| Placebo Prior to FMT | 4 |
Changes in Fecal Bacterial Composition Associated With FMT Overall Antibiotic and Placebo Conditioning Groups) by Laboratory Analysis.
Microbiome composition was assessed post FMT using fecal DNA extraction and sequences. Outcome is reported as the change in relative abundance of the family Ruminococcaceae. (NCT02730962)
Timeframe: Baseline and 10 weeks
| Intervention | percent relative abundance (Mean) |
|---|
| Antibiotics Prior to FMT | 5 |
| Placebo Prior to FMT | 17 |
Microbiome Composition
Outcome is reported as the Shannon alpha diversity index (unitless measure) at baseline and 7 days post FMT. (NCT02730962)
Timeframe: 7 days
| Intervention | unitless measure (Mean) |
|---|
| Baseline | 7 days post FMT |
|---|
| Antibiotics Prior to FMT | 3.3 | 3.3 |
,| Placebo Prior to FMT | 3.3 | 1.2 |
Measured Adherence to ZIANA Gel or Generic Topical Clindamycin 1% Gel Each Morning Plus Generic Topical Tretinoin 0.025% Cream Each Evening in Subjects With Mild to Moderate Acne
Percentage of prescribed doses taken as measured by a Medication Event Monitoring System (MEMS) cap (NCT01047189)
Timeframe: 12 weeks
| Intervention | Percent of doses (Median) |
|---|
| Ziana Gel | 88 |
| Clindamycin Plus Tretinoin Applied Separately | 61 |
The Change (Dynamic Assessment) From Baseline to Week 12 (or End of Treatment) in Total Acne Lesion Count
(NCT01047189)
Timeframe: Baseline to 12 weeks
| Intervention | percentage of lesions (Mean) |
|---|
| Ziana Gel | -51 |
| Clindamycin Plus Tretinoin Applied Separately | -32 |
Probing Depth
The size of the periodontal pocket (NCT03374176)
Timeframe: 7 days
| Intervention | mm (Mean) |
|---|
| AMX-MET | 0.44 |
| Clindamycin | 0.50 |
Sites With Bleeding on Probing
"Refers to bleeding on probing 0: absence of inflammation~mild inflammation; a slight change in color, little change in the texture of any portion of but not the entire marginal or papillary gingival unit~mild inflammation; criteria as above but involving the entire marginal or papillary gingival unit~moderate inflammation; glazing, redness, edema, and/or hypertrophy of the marginal or papillary gingival unit 4; severe inflammation; marked redness, edema, and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration" (NCT03374176)
Timeframe: 7 days
| Intervention | Sites (Mean) |
|---|
| AMX-MET | 16.1 |
| Clindamycin | 22.1 |
Sites With Plaques
"0: no plaque~separate flecks of plaque at the cervical margin of the tooth~a thin continuous band of plaque (up to 1 mm) at the cervical margin of the tooth~a continuous band of plaque wider than 1 mm but covering less than one-third of the crown of the tooth~plaque covering at least one-third but less than two-thirds of the crown of the tooth~plaque covering two-thirds or more of the crown of the tooth. A higher scores mean a worse outcome" (NCT03374176)
Timeframe: 7 days
| Intervention | Sites (Mean) |
|---|
| AMX-MET | 17.6 |
| Clindamycin | 15.8 |
Total Count of All Teeth Lost Across All Participants
The total count of all teeth lost in all participants. (NCT03374176)
Timeframe: 2 years
| Intervention | total count of all teeth lost (Number) |
|---|
| AMX-MET | 0 |
| Clindamycin | 0 |
Number of Participants With Presence of Wound Infection
Hand lacerations will be examined 10-14 days after initial wound closure and will be assessed for presence of infection. (NCT01155154)
Timeframe: 2 weeks
| Intervention | participants (Number) |
|---|
| Clindamycin | 0 |
| Cepahlexin | 0 |
| Placebo | 1 |
Clinical Resolution of Skin Abscess at Routine Follow-up Visit 10-14 Days Post Operation.
(NCT01498744)
Timeframe: At office visit 10-14 days post operation
| Intervention | participants (Number) |
|---|
| 5 Days Postoperative Antibiotic | 0 |
| 1 Day Postoperative Antibiotic | 1 |
Additional Skin and Soft Tissue Infections in Patient
The outcome measure was reported by responding to a yes/no (NCT01498744)
Timeframe: Three timepoints: 10-14 days post operation, 3 months post op, and 9 months post op
| Intervention | participants (Number) |
|---|
| 10-14 Days(n=14,19) | 90 Day(n=13,15) | 9 Month(n=10,9) |
|---|
| 1 Day Postoperative Antibiotic | 2 | 4 | 3 |
,| 5 Days Postoperative Antibiotic | 0 | 2 | 2 |
Complication to Antibiotic Regime
(NCT01498744)
Timeframe: Three timepoints: 10-14 days post operation, 3 months post op, and 9 months post op
| Intervention | participants (Number) |
|---|
| 10-14 Days(n=14,19) | 90 Day(n=0,0) | 9 Month(n=0,0) |
|---|
| 1 Day Postoperative Antibiotic | 2 | 0 | 0 |
,| 5 Days Postoperative Antibiotic | 0 | 0 | 0 |
Clinical Success on Investigator's Global Evaluation
"Percentage of subjects with a clinical response of success, defined as an IGA score that is at least 2 grades less than the baseline assessment." (NCT01796665)
Timeframe: Baseline to week 12
| Intervention | Participants (Count of Participants) |
|---|
| Test Product | 103 |
| Reference Product | 120 |
| Placebo Product | 23 |
Mean Percent Change in the Inflammatory (Papules and Pustules) Lesion Count
Per protocol population (NCT01796665)
Timeframe: Baseline to week 12
| Intervention | percent change of lesion counts (Mean) |
|---|
| Test Product | 61.70 |
| Reference Product | 63.89 |
| Placebo Product | 42.22 |
Mean Percent Change in the Non-inflammatory (Open and Closed Comedones) Lesion Count
(NCT01796665)
Timeframe: Baseline to week 12
| Intervention | percent change of lesion counts (Mean) |
|---|
| Test Product | 51.57 |
| Reference Product | 51.59 |
| Placebo Product | 33.33 |
Hospital Readmission
Hospital readmission (NCT03478163)
Timeframe: 6 weeks
| Intervention | Participants (Count of Participants) |
|---|
| Control | 0 |
| Antibiotics | 0 |
Hysterectomy
Hysterectomy (NCT03478163)
Timeframe: 6 weeks
| Intervention | Participants (Count of Participants) |
|---|
| Control | 0 |
| Antibiotics | 0 |
Maternal Death
Maternal death (NCT03478163)
Timeframe: 6 weeks
| Intervention | Participants (Count of Participants) |
|---|
| Control | 0 |
| Antibiotics | 0 |
Maternal ICU Admission
Maternal ICU Admission (NCT03478163)
Timeframe: 6 weeks
| Intervention | Participants (Count of Participants) |
|---|
| Control | 0 |
| Antibiotics | 0 |
Number of Participants With a Fever
Number of participants with a fever > 38 degrees celsius (NCT03478163)
Timeframe: 6 weeks
| Intervention | Participants (Count of Participants) |
|---|
| Control | 0 |
| Antibiotics | 3 |
Postpartum Endometritis
Number of participants with postpartum endometritis as defined by clinical documentation (NCT03478163)
Timeframe: 6 weeks
| Intervention | Participants (Count of Participants) |
|---|
| Control | 0 |
| Antibiotics | 3 |
Postpartum Hemoglobin
Postpartum hemoglobin value (NCT03478163)
Timeframe: 2 weeks
| Intervention | g/dL (Mean) |
|---|
| Control | 9.52 |
| Antibiotics | 9.23 |
Receiving Postpartum Antibiotics
Receiving postpartum antibiotics (NCT03478163)
Timeframe: 6 weeks
| Intervention | Participants (Count of Participants) |
|---|
| Control | 0 |
| Antibiotics | 3 |
Blood Transfusion
Blood transfusions (NCT03478163)
Timeframe: 2 weeks
| Intervention | Participants (Count of Participants) |
|---|
| 0 RBC Transfusions | 1 RBC Transfusions | 2 RBC Transfusions | 3 RBC Transfusions |
|---|
| Antibiotics | 0 | 2 | 2 | 1 |
,| Control | 3 | 0 | 2 | 0 |
EBL
Estimated blood loss prior to removal and with IBT in (NCT03478163)
Timeframe: 2 weeks
| Intervention | cc (Mean) |
|---|
| Estimated Blood Loss Pre-IBT | Estimated Blood Loss with IBT in |
|---|
| Antibiotics | 1385.83 | 197 |
,| Control | 1626 | 165.6 |
Resource Utilization Measures
Duration of admission to maternal-fetal care unit and total hospital admission length of stay (NCT03478163)
Timeframe: 6 weeks
| Intervention | hours (Mean) |
|---|
| MFCU Length of Stay | Total Hospital Length of Stay |
|---|
| Antibiotics | 30.67 | 88.83 |
,| Control | 29.75 | 83.75 |
"The Percentage of Subjects With a Clinical Response (IGA) of Success at Week 12"
Investigator's Global Assessment, IGA. Overall severity of acne was assessed using a five-point scale from 0=Clear to 4=Severe. Subjects must have had an IGA score of 2 (mild), 3 (moderate), or 4 (severe) at Baseline. Success is defined as an IGA score at week 12 that is at least 2 grades less than the baseline assessment. (NCT03717506)
Timeframe: 12 weeks
| Intervention | Participants (Count of Participants) |
|---|
| Test Product | 78 |
| Reference Product | 64 |
| Placebo | 18 |
Incidence of Adverse Events
Adverse Events (AEs) will be assessed by the investigator and the incidence (severity and causality) of any local and systemic AEs will be reported by number and percentage. (NCT03717506)
Timeframe: Day 1 through Day 85
| Intervention | Participants (Count of Participants) |
|---|
| Test Product | 53 |
| Reference Product | 41 |
| Placebo | 29 |
Mean Percent Change in the Non-inflammatory Lesion Counts
Percent Change (i.e., reduction) from Baseline to Week 12 in non-inflammatory (open and closed comedones) lesion counts. (NCT03717506)
Timeframe: 12 weeks
| Intervention | percent change (Mean) |
|---|
| Test Product | -52.7 |
| Reference Product | -54.3 |
| Placebo | -43.0 |
Mean Percent Change in the Number of Inflamed Lesions
Percent Change from Baseline to Week 12 in inflammatory lesion counts (Papules/Pustules). (NCT03717506)
Timeframe: 12 weeks
| Intervention | percent change (Mean) |
|---|
| Test Product | -39.4 |
| Reference Product | -40.0 |
| Placebo | -35.1 |
Percentage Change From Baseline (Day 1) of Inflammatory Lesion (IL) Count at Week 4 - Superiority Analysis
A count of IL (papules and pustules, including nasal lesions) was performed at baseline and up to Week 12. Lesion counts were confined to the face. Baseline was defined at Visit 1 (Day 1). Change from Baseline in the number of IL was defined as Week 4 values minus the Baseline values. Raw data has been presented for outcome measure results; however, p value is derived from the Wilcoxon test mean scores. (NCT02058628)
Timeframe: Baseline (Day 1) and Week 4
| Intervention | Percent change (Mean) |
|---|
| DUAC® | -51.9 |
| SKINOREN® | -38.1 |
Speed of Onset : Time to 50 Percent Reduction in Total Lesion Count
The average time to 50 percent reduction of the calculated total lesion count was analyzed by determination of the number of days between Baseline and the first visit with a 50 percent reduction of the count. (NCT02058628)
Timeframe: Week 12
| Intervention | Days (Median) |
|---|
| DUAC® | 52.0 |
| SKINOREN® | 55.0 |
Absolute Change From Baseline in IL, Non-inflammatory Lesions (NIL) and Calculated Total Lesions to Weeks 2, 4, 8 and 12
A count of IL (papules and pustules, including nasal lesions), NIL (open and closed comedones) and total lesions was performed at baseline and up to Week 12. Lesion counts were confined to the face. Baseline was defined at Visit 1 (Day 1). Change from Baseline in the number of IL was defined as week 12 values minus the Baseline values. (NCT02058628)
Timeframe: Baseline (Day 1) up to Week 2, 4, 8, 12
| Intervention | Lesions (Mean) |
|---|
| IL, WEEK 2 | IL, WEEK 4 | IL, WEEK 8 | IL, WEEK 12 | NIL, WEEK 2 | NIL, WEEK 4 | NIL, WEEK 8 | NIL, WEEK 12 | Total lesion, Week 2 | Total lesion, Week 4 | Total lesion, Week 8 | Total lesion, Week 12 |
|---|
| DUAC® | -10.3 | -14.2 | -17.7 | -19.6 | -13.7 | -21.2 | -26.8 | -32.0 | -23.9 | -35.4 | -44.4 | -51.6 |
,| SKINOREN® | -6.3 | -9.7 | -12.7 | -14.2 | -8.5 | -16.0 | -20.9 | -23.3 | -14.8 | -25.7 | -33.6 | -37.5 |
Absolute Change From Baseline in Total Score as Per Children's Dermatology Life Quality Index (CDLQI) at Week 2,4,8 and 12
This outcome measure was a measure of QOL. The CDLQI was used to assess the quality of life at each visit. Participants completed the questionnaire to evaluate how their acne has affected their life. The DLQI is a 10 item questionnaire, which addresses feelings, daily activities, leisure, work, school, personal relationships, and treatment. Each question was scored out of 0-3, as follows: 0- Not at all, 1- A little, 2- A lot, 3- very much, indicating 0 as the least and 3 as the best quality Index. The sub-scale scores of 10 questions were combined and a composite score was presented. The total score ranged from 0 to 30, 0 indicated the least and highest score indicated the best quality Index. The CDLQI was for participants with 12 to 16 years of age. Baseline was defined at Visit 1 (Day 1). Change from Baseline is the value at indicated time point minus the Baseline value. (NCT02058628)
Timeframe: Baseline (Day 1) up to Weeks 2, 4, 8, 12
| Intervention | Scores on a scale (Mean) |
|---|
| Week 2 | Week 4 | Week 8 | Week 12 |
|---|
| DUAC® | -2.61 | -2.55 | -2.68 | -2.87 |
,| SKINOREN® | -1.31 | -1.55 | -1.67 | -1.55 |
Absolute Change From Baseline in Total Score as Per Dermatology Life Quality Index (DLQI) at Week 2,4,8 and 12
This outcome measure was a measure of quality of life (QOL). The DLQI was used to assess the quality of life at each visit. Participants completed the questionnaire to evaluate how their acne has affected their life. The DLQI is a 10 item questionnaire, which addresses feelings, daily activities, leisure, work, school, personal relationships, and treatment. Each question was scored out of 0-3, as follows: 0- Not at all, 1- A little, 2- A lot, 3- very much, indicating 0 as the least and 3 as the best quality Index. The sub-scale scores of 10 questions were combined and a composite score was presented. The total score ranged from 0 to 30, 0 indicated the least and highest score indicated the best quality Index. The DLQI was for participants with 17 to 45 years of age. Baseline was defined at Visit 1 (Day 1). Change from Baseline is the value at indicated time point minus the Baseline value. (NCT02058628)
Timeframe: Baseline (Day 1) up to Weeks 2, 4, 8, 12
| Intervention | Scores on a scale (Mean) |
|---|
| Week 2 | Week 4 | Week 8 | Week 12 |
|---|
| DUAC® | -2.28 | -3.39 | -4.04 | -4.46 |
,| SKINOREN® | -2.17 | -3.15 | -3.38 | -3.12 |
Number of Participants With Change From Baseline in Investigator's Static Global Assessment (ISGA) to Weeks 2,4,8 and 12
ISGA was conducted at all study visits. The area considered for the ISGA was confined to the face. A 0-5 point rating scale was used: 0 means Clear- Clear skin with no IL or NIL, 1 means Almost Clear- Rare NIL with no more than one small IL, 2 means Mild- Some NIL with no more than a few IL (papules/pustules only, no nodular lesions), 3 means Moderate- Up to many NIL and may have some IL, but no more than one small nodular lesion, 4 means Severe- Up to many NIL and IL, but no more than a few nodular lesions and 5 means Very Severe- Many NIL and IL and more than a few nodular lesions, may have cystic lesions. (NCT02058628)
Timeframe: Baseline (Day 1) up to Weeks 2, 4, 8, 12
| Intervention | Participants (Count of Participants) |
|---|
| Mild (Baseline) to Almost Clear (Week 2) | Mild (Baseline) to Moderate (Week 2) | Moderate (Baseline) to Almost Clear (Week 2) | Moderate (Baseline) to Mild (Week 2) | Moderate (Baseline) to Missing (Week 2) | Mild (Baseline) to Almost Clear (Week 4) | Mild (Baseline) to Moderate (Week 4) | Mild (Baseline) to Missing (Week 4) | Moderate (Baseline) to Almost Clear (Week 4) | Moderate (Baseline) to Mild (Week 4) | Moderate (Baseline) to Severe (Week 4) | Moderate (Baseline) to Missing (Week 4) | Mild (Baseline) to Clear (Week 8) | Mild (Baseline) to Almost Clear (Week 8) | Mild (Baseline) to Moderate (Week 8) | Mild (Baseline) to Missing (Week 8) | Moderate (Baseline) to Clear (Week 8) | Moderate (Baseline) to Almost Clear (Week 8) | Moderate (Baseline) To Mild (Week 8) | Moderate (Baseline) to Missing (Week 8) | Mild (Baseline) to Clear (Week 12) | Mild (Baseline) to Almost Clear (Week 12) | Mild (Baseline) to Moderate (Week 12) | Mild (Baseline) to Missing (Week 12) | Moderate (Baseline) to Clear (Week 12) | Moderate (Baseline) to Almost Clear (Week 12) | Moderate (Baseline) to Mild (Week 12) | Moderate (Baseline) to Severe (Week 12) | Moderate (Baseline) to Missing (Week 12) |
|---|
| DUAC® | 4 | 3 | 1 | 26 | 2 | 8 | 1 | 0 | 11 | 29 | 0 | 2 | 2 | 10 | 3 | 0 | 1 | 15 | 32 | 3 | 3 | 12 | 2 | 0 | 2 | 19 | 33 | 0 | 0 |
,| SKINOREN® | 1 | 8 | 1 | 14 | 0 | 8 | 4 | 1 | 3 | 24 | 1 | 0 | 0 | 10 | 8 | 4 | 0 | 5 | 27 | 2 | 1 | 9 | 8 | 2 | 0 | 9 | 26 | 2 | 2 |
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Tolerability was assessed by investigator on a 0-3 point rating scale for erythema (0- None, 1- Slight, 2- Some and 3- Very red), dryness (0- None, 1- Slight, 2- Some and 3- Very dry) and peeling (0- None, 1- Slight, 2- Moderate and 3- Strong). A shift table was provided to deduce how the results are varying from the baseline visit to post-baseline visits. Change from Baseline is the value at indicated time point minus the Baseline value. (NCT02058628)
Timeframe: Baseline (Day 1) and Weeks 2, 4, 8, 12
| Intervention | Participants (Count of Participants) |
|---|
| Erythema None (Baseline) To Slight (Week 2) | Erythema None (Baseline) To Some (Week 2) | Erythema None (Baseline) To Missing (Week 2) | Erythema Slight (Basline) To None (Week 2) | Erythema Slight (Baseline) To Some (Week 2) | Erythema Slight (Baseline) To Missing (Week 2) | Erythema Some (Baseline) To None (Week 2) | Erythema Some (Baseline) To Slight (Week 2) | Erythema Very Red (Baseline) To Slight (Week 2) | Erythema Very Red (Baseline) To Some (Week 2) | Erythema Missing (Baseline) To None (Week 2) | Erythema None (Baseline) To Slight (Week 4) | Erythema None (Baseline) To Some (Week 4) | Erythema None (Baseline) To Missing (Week 4) | Erythema Slight (Baseline) To None (Week 4) | Erythema Slight (Baseline) To Some (Week 4) | Erythema Slight (Baseline) To Missing (Week 4) | Erythema Some (Baseline) To None (Week 4) | Erythema Some (Baseline) To Slight (Week 4) | Erythema Some (Baseline) To Missing (Week 4) | Erythema Very Red (Baseline) To Slight (Week 4) | Erythema Very Red (Baseline) To Some (Week 4) | Erythema Missing (Baseline) To None (Week 4) | Erythema None (Baseline) To Slight (Week 8) | Erythema None (Baseline) To Some (Week 8) | Erythema None (Baseline) To Missing (Week 8) | Erythema Slight (Baseline) To None (Week 8) | Erythema Slight (Baseline) To Some (Week 8) | Erythema Slight (Baseline) To Missing (Week 8) | Erythema Some (Baseline) To None (Week 8) | Erythema Some (Baseline) To Slight (Week 8) | Erythema Some (Baseline) To Very Red (Week 8) | Erythema Some (Baseline) To Missing (Week 8) | Erythema Very Red (Baseline) To None (Week 8) | Erythema Very Red (Baseline) To Slight (Week 8) | Erythema Missing (Baseline) To Slight (Week 8) | Erythema None (Baseline) To Slight (Week 12) | Erythema None (Baseline) To Missing (Week 12) | Erythema Slight (Baseline) To None (Week 12) | Erythema Slight (Baseline) To Some (Week 12) | Erythema Slight (Baseline) To Very Red (Week 8) | Erythema Slight (Baseline) To Missing (Week 12) | Erythema Some (Baseline) To None (Week 12) | Erythema Some (Baseline) To Slight (Week 12) | Erythema Some (Baseline) To Missing (Week 12) | Erythema Very Red (Baseline) To None (Week 12) | Erythema Very Red (Baseline) To Slight (Week 12) | Erythema Missing (Baseline) To Slight (Week 12) | Peeling None (Baseline) To Slight (Week 2) | Peeling None (Baseline) To Moderate (Week 2) | Peeling None (Baseline) To Missing (Week 2) | Peeling Slight (Baseline) To None (Week 2) | Peeling Slight (Baseline) To Moderate (Week 2) | Peeling Moderate (Baseline) To None (Week 2) | Peeling Moderate (Baseline) To Slight (Week 2) | Peeling Missing (Baseline) To None (Week 2) | Peeling None (Baseline) To Slight (Week 4) | Peeling None (Baseline) To Missing (Week 4) | Peeling Slight (Baseline) To None (Week 4) | Peeling Slight (Baseline) To Moderate (Week 4) | Peeling Moderate (Baseline) To None (Week 4) | Peeling Moderate (Baseline) To Slight (Week 4) | Peeling Missing (Baseline) To None (Week 4) | Peeling None (Baseline) To Slight (Week 8) | Peeling None (Baseline) To Missing (Week 8) | Peeling Slight (Baseline) To None (Week 8) | Peeling Slight (Baseline) To Missing (Week 8) | Peeling Moderate (Baseline) To None (Week 8) | Peeling Moderate (Baseline) To Slight (Week 8) | Peeling Missing (Baseline) To None (Week 8) | Peeling None (Baseline) To Slight (Week 12) | Peeling None (Baseline) To Missing (Week 12) | Peeling Slight (Baseline) To None (Week 12) | Peeling Slight (Baseline) To Missing (Week 12) | Peeling Moderate (Baseline) To None (Week 12) | Peeling Moderate (Baseline) To Slight (Week 12) | Peeling Missing (Baseline) To None (Week 12) | Dryness None (Baseline) To Slight (Week 2) | Dryness None (Baseline) To Some (Week 2) | Dryness None (Baseline) To Missing (Week 2) | Dryness Slight (Baseline) To None (Week 2) | Dryness Slight (Baseline) To Some (Week 2) | Dryness Some (Baseline) To None (Week 2) | Dryness Some (Baseline) To Slight (Week 2) | Dryness Missing (Baseline) To None (Week 2) | Dryness None (Baseline) To Slight (Week 4) | Dryness None (Baseline) To Missing (Week 4) | Dryness Slight (Baseline) To None (Week 4) | Dryness Slight (Baseline) To Some (Week 4) | Dryness Some (Baseline) To None (Week 4) | Dryness Some (Baseline) To Slight (Week 4) | Dryness Missing (Baseline) To None (Week 4) | Dryness None (Baseline) To Slight (Week 8) | Dryness None (Baseline) To Missing (Week 8) | Dryness Slight (Baseline) To None (Week 8) | Dryness Slight (Baseline) To Some (Week 8) | Dryness Slight (Baseline) To Missing (Week 8) | Dryness Some (Baseline) To None (Week 8) | Dryness Some (Baseline) To Slight (Week 8) | Dryness Missing (Baseline) To None (Week 8) | Dryness None (Baseline) To Some (Week 12) | Dryness None (Baseline) To Slight (Week 12) | Dryness None (Baseline) To Missing (Week 12) | Dryness Slight (Baseline) To None (Week 12) | Dryness Slight (Baseline) To Some (Week 12) | Dryness Slight (Baseline) To Missing (Week 12) | Dryness Some (Baseline) To None (Week 12) | Dryness Some (Baseline) To Slight (Week 12) | Dryness Missing (Baseline) To None (Week 12) |
|---|
| DUAC® | 11 | 0 | 1 | 12 | 1 | 1 | 3 | 10 | 1 | 2 | 1 | 9 | 1 | 1 | 18 | 3 | 1 | 5 | 11 | 0 | 2 | 1 | 1 | 10 | 0 | 1 | 15 | 5 | 2 | 8 | 9 | 1 | 0 | 2 | 1 | 1 | 6 | 0 | 21 | 0 | 1 | 0 | 9 | 8 | 0 | 0 | 1 | 1 | 13 | 1 | 2 | 8 | 3 | 2 | 2 | 1 | 9 | 2 | 15 | 1 | 2 | 1 | 1 | 9 | 3 | 18 | 0 | 3 | 1 | 1 | 7 | 0 | 14 | 0 | 2 | 2 | 1 | 14 | 1 | 2 | 11 | 3 | 4 | 1 | 1 | 9 | 2 | 14 | 2 | 4 | 3 | 1 | 8 | 3 | 19 | 0 | 0 | 5 | 4 | 1 | 1 | 2 | 0 | 14 | 0 | 0 | 6 | 3 | 1 |
,| SKINOREN® | 18 | 1 | 0 | 12 | 8 | 0 | 1 | 11 | 1 | 2 | 0 | 13 | 3 | 0 | 19 | 1 | 1 | 3 | 9 | 1 | 2 | 1 | 0 | 19 | 2 | 2 | 17 | 1 | 3 | 1 | 12 | 0 | 1 | 0 | 3 | 0 | 18 | 2 | 22 | 2 | 0 | 1 | 4 | 9 | 1 | 2 | 1 | 0 | 11 | 0 | 0 | 8 | 2 | 0 | 1 | 0 | 11 | 1 | 13 | 1 | 1 | 0 | 0 | 10 | 5 | 12 | 1 | 1 | 0 | 0 | 11 | 3 | 15 | 1 | 0 | 1 | 0 | 9 | 3 | 0 | 7 | 6 | 2 | 2 | 0 | 12 | 1 | 10 | 3 | 1 | 5 | 0 | 11 | 5 | 12 | 1 | 1 | 1 | 5 | 0 | 0 | 8 | 3 | 15 | 1 | 1 | 3 | 3 | 0 |
Number of Participants With Change From Baseline in Local Tolerability as Per Participant's Assessment at Weeks 2, 4, 8 and 12
Tolerability was assessed by the participants based on a 0-3 point rating scale for stinging/burning (S/B) and pruritus of the face (0- None, 1- Slight, 2- Moderate and 3- Strong). A shift table was provided to deduce how the results are varying from the Baseline visit to post-baseline visits. (NCT02058628)
Timeframe: Baseline (Day 1), Weeks 2, 4, 8 and 12
| Intervention | Participants (Count of Participants) |
|---|
| S/B None (Baseline) To Slight (Week 2) | S/B None (Baseline) To Moderate (Week 2) | S/B None (Baseline) To Strong (Week 2) | S/B None (Baseline) To Missing (Week 2) | S/B Slight (Baseline) To None (Week 2) | S/B Slight (Baseline) To Moderate (Week 2) | S/B Slight (Baseline) To Strong (Week 2) | S/B Moderate (Baseline) To None (Week 2) | S/B Moderate (Baseline) To Slight (Week 2) | S/B Strong (Baseline) To None (Week 2) | S/B Missing (Baseline) To None (Week 2) | S/B None (Baseline) To Slight (Week 4) | S/B None (Baseline) To Moderate (Week 4) | S/B None (Baseline) To Missing (Week 4) | S/B Slight (Baseline) To None (Week 4) | S/B Slight (Baseline) To Moderate (Week 4) | S/B Slight (Baseline) To Strong (Week 4) | S/B Moderate (Baseline) To None (Week 4) | S/B Moderate (Baseline) To Slight (Week 4) | S/B Moderate (Baseline) To Strong (Week 4) | S/B Strong (Baseline) To None (Week 4) | S/B Missing (Baseline) To Slight (Week 4) | S/B None (Baseline) To Slight (Week 8) | S/B None (Baseline) To Moderate (Week 8) | S/B None (Baseline) To Missing (Week 8) | S/B None (Baseline) To Strong (Week 8) | S/B Slight (Baseline) To None (Week 8) | S/B Slight (Baseline) To Moderate (Week 8) | S/B Slight (Baseline) To Strong (Week 8) | S/B Moderate (Baseline) To None (Week 8) | S/B Moderate (Baseline) To Slight (Week 8) | S/B Moderate (Baseline) To Missing (Week 8) | S/B Strong (Baseline) To None (Week 8) | S/B Missing (Baseline) To None (Week 8) | S/B None (Baseline) To Slight (Week 12) | S/B None (Baseline) To Moderate (Week 12) | S/B None (Baseline) To Strong (Week 12) | S/B None (Baseline) To Missing (Week 12) | S/B Slight (Baseline) To None (Week 12) | S/B Slight (Baseline) To Moderate (Week 12) | S/B Slight (Baseline) To Strong (Week 12) | S/B Moderate (Baseline) To None (Week 12) | S/B Moderate (Baseline) To Slight (Week 12) | S/B Strong (Baseline) To Slight (Week 12) | S/B Missing (Baseline) To None (Week 12) | Pruritus None (Baseline) To Slight (Week 2) | Pruritus None (Baseline) To Moderate (Week 2) | Pruritus None (Baseline) To Strong (Week 2) | Pruritus None (Baseline) To Missing (Week 2) | Pruritus Slight (Baseline) To None (Week 2) | Pruritus Slight (Baseline) To Moderate (Week 2) | Pruritus Slight (Baseline) To Strong (Week 2) | Pruritus Moderate (Baseline) To None (Week 2) | Pruritus Moderate (Baseline) To Slight (Week 2) | Pruritus Missing (Baseline) To None (Week 2) | Pruritus None (Baseline) To Slight (Week 4) | Pruritus None (Baseline) To Moderate (Week 4) | Pruritus None (Baseline) To Missing (Week 4) | Pruritus Slight (Baseline) To None (Week 4) | Pruritus Slight (Baseline) To Moderate (Week 4) | Pruritus Slight (Baseline) To Strong (Week 4) | Pruritus Moderate (Baseline) To None (Week 4) | Pruritus Moderate (Baseline) To Slight (Week 4) | Pruritus Missing (Baseline) To None (Week 4) | Pruritus None (Baseline) To Slight (Week 8) | Pruritus None (Baseline) To Missing (Week 8) | Pruritus None (Baseline) To Strong (Week 8) | Pruritus Slight (Baseline) To None (Week 8) | Pruritus Slight (Baseline) To Moderate (Week 8) | Pruritus Slight (Baseline) To Strong (Week 8) | Pruritus Slight (Baseline) To Missing (Week 8) | Pruritus Moderate (Baseline) To None (Week 8) | Pruritus Moderate (Baseline) To Slight (Week 8) | Pruritus Strong (Baseline) To Moderate (Week 8) | Pruritus Missing (Baseline) To None (Week 8) | Pruritus None (Baseline) To Slight (Week 12) | Pruritus None (Baseline) To Moderate (Week 12) | Pruritus None (Baseline) To Strong (Week 12) | Pruritus None (Baseline) To Missing (Week 12) | Pruritus Slight (Baseline) To None (Week 12) | Pruritus Slight (Baseline) To Moderate (Week 12) | Pruritus Slight (Baseline) To Strong (Week 12) | Pruritus Moderate (Baseline) To None (Week 12) | Pruritus Moderate (Baseline) To Slight (Week 12) | Pruritus Strong (Baseline) To Slight (Week 12) | Pruritus Missing (Baseline) To None (Week 12) |
|---|
| DUAC® | 14 | 4 | 1 | 2 | 14 | 3 | 0 | 0 | 1 | 0 | 1 | 11 | 1 | 2 | 12 | 1 | 0 | 0 | 1 | 0 | 0 | 1 | 5 | 1 | 3 | 0 | 18 | 1 | 0 | 0 | 1 | 0 | 0 | 1 | 6 | 1 | 1 | 1 | 18 | 0 | 0 | 1 | 0 | 0 | 1 | 14 | 4 | 0 | 2 | 13 | 5 | 1 | 2 | 1 | 1 | 14 | 2 | 2 | 17 | 2 | 0 | 2 | 2 | 1 | 13 | 3 | 0 | 21 | 4 | 0 | 0 | 3 | 1 | 0 | 1 | 11 | 1 | 0 | 0 | 22 | 2 | 0 | 3 | 1 | 0 | 1 |
,| SKINOREN® | 23 | 8 | 4 | 0 | 10 | 2 | 2 | 1 | 3 | 1 | 0 | 29 | 6 | 1 | 9 | 1 | 1 | 2 | 3 | 1 | 1 | 0 | 21 | 4 | 5 | 1 | 10 | 1 | 1 | 1 | 2 | 1 | 1 | 0 | 19 | 5 | 2 | 4 | 9 | 3 | 1 | 2 | 3 | 1 | 0 | 27 | 7 | 1 | 0 | 10 | 9 | 4 | 4 | 1 | 0 | 30 | 5 | 1 | 12 | 6 | 1 | 2 | 2 | 0 | 26 | 3 | 1 | 11 | 4 | 2 | 3 | 2 | 3 | 1 | 0 | 22 | 3 | 1 | 4 | 11 | 6 | 2 | 1 | 4 | 1 | 0 |
Number of Participants With Participant Global Change Assessment Score 12 Weeks
An SGCA was conducted by the participant to assess the efficacy of treatment on Week 2, 4, 8 and 12 as Very Much Improved, Much Improved, Minimally Improved, No Change, Minimally Worse, Much Worse, Very Much Worse and missing. (NCT02058628)
Timeframe: Weeks 2, 4, 8 and 12
| Intervention | Participants (Count of Participants) |
|---|
| Very much improved (Week 2) | Much improved (Week 2) | Minimally improved (Week 2) | No change (Week 2) | Minimally worse (Week 2) | Missing (Week 2) | Very much improved (Week 4) | Much improved (Week 4) | Minimally improved (Week 4) | No change (Week 4) | Minimally worse (Week 4) | Missing (Week 4) | Very much improved (Week 8) | Much improved (Week 8) | Minimally improved (Week 8) | No change (Week 8) | Minimally worse (Week 8) | Much worse (Week 8) | Very much worse (Week 8) | Missing (Week 8) | Very much improved (Week 12) | Much improved (Week 12) | Minimally improved (Week 12) | No change (Week 12) | Minimally worse (Week 12) | Much worse (Week 12) | Very much worse (Week 12) | Missing (Week 12) |
|---|
| DUAC® | 4 | 51 | 44 | 6 | 0 | 2 | 5 | 48 | 44 | 2 | 6 | 2 | 9 | 54 | 30 | 7 | 3 | 1 | 0 | 3 | 14 | 48 | 29 | 10 | 4 | 0 | 2 | 0 |
,| SKINOREN® | 2 | 30 | 56 | 14 | 6 | 0 | 0 | 39 | 49 | 12 | 7 | 1 | 1 | 44 | 32 | 15 | 8 | 1 | 1 | 6 | 8 | 38 | 33 | 17 | 5 | 2 | 1 | 4 |
Number of Participants With Participant Satisfaction Score at Week 12 (Simple Grading)
The product acceptability and preference questionnaire (PAP-Q ) served as a patient satisfaction score and was performed only once at the final study visit (ie, after 12 weeks (V5) or earlier in case of premature termination). Severity of each facial acne sign and symptom (scaling, redness, dryness, burning, itching) was based on a 0-5 point rating scale (0- None, 1- Very minimal, 2- Mild, 3- Moderate, 4- Severe, 5- Very severe). (NCT02058628)
Timeframe: Week 12
| Intervention | Participants (Count of Participants) |
|---|
| Redness, None | Redness, Very minimal | Redness, Mild | Redness, Moderate | Redness, Severe | Redness, Very severe | Redness, Not applicable | Dryness, None | Dryness, Very minimal | Dryness, Mild | Dryness, Moderate | Dryness, Severe | Dryness, Very severe | Dryness, Not applicable | Burning, None | Burning, Very minimal | Burning, Mild | Burning, Moderate | Burning, Severe | Burning, Very severe | Burning, Not applicable | Itching, None | Itching, Very minimal | Itching, Mild | Itching, Moderate | Itching, Severe | Itching, Very severe | Itching, Not applicable | Scaling, None | Scaling, Very minimal | Scaling, Mild | Scaling, Moderate | Scaling, Severe | Scaling, Very severe | Scaling, Not applicable |
|---|
| DUAC® | 55 | 32 | 8 | 9 | 2 | 1 | 0 | 43 | 32 | 20 | 9 | 2 | 1 | 0 | 90 | 8 | 5 | 3 | 1 | 0 | 0 | 73 | 17 | 10 | 6 | 1 | 0 | 0 | 69 | 24 | 7 | 2 | 4 | 1 | 0 |
,| SKINOREN® | 47 | 20 | 17 | 13 | 5 | 2 | 1 | 41 | 28 | 24 | 7 | 2 | 2 | 1 | 50 | 28 | 12 | 9 | 5 | 0 | 1 | 38 | 30 | 20 | 11 | 3 | 2 | 1 | 77 | 9 | 7 | 7 | 4 | 0 | 1 |
Number of Treatment Adherent Participants at Week 12
The general assessment of 'overall satisfaction' with study therapy was assessed at week 12 on a 0-4 point rating scale (0-Very satisfied, 1- Satisfied, 2- Neutral, 3- Unsatisfied and 4- Very unsatisfied). (NCT02058628)
Timeframe: Week 12
| Intervention | Participants (Count of Participants) |
|---|
| Very satisfied | Satisfied | Neutral | Unsatisfied | Very unsatisfied |
|---|
| DUAC® | 41 | 61 | 4 | 1 | 0 |
,| SKINOREN® | 26 | 43 | 21 | 11 | 3 |
Percentage Change From Baseline in IL, NIL and Calculated Total Lesions at Weeks 2, 4, 8 and 12
A count of IL (papules and pustules, including nasal lesions),NIL (open and closed comedones) and total lesions was performed at baseline and up to Week 12. Lesion counts were confined to the face. Baseline was defined at Visit 1 (Day 1). Change from Baseline in the number of IL was defined as week 12 values minus the Baseline values. (NCT02058628)
Timeframe: Baseline (Day 1) up to Week 2, 4, 8, 12
| Intervention | Percent change (Mean) |
|---|
| IL, Week 2 | IL, Week 4 | IL, Week 8 | IL, Week 12 | NIL, Week 2 | NIL, Week 4 | NIL, Week 8 | NIL, Week 12 | Total lesions, Week 2 | Total lesions, Week 4 | Total lesions, Week 8 | Total lesions, Week 12 |
|---|
| DUAC® | -37.3 | -52.2 | -65.0 | -72.3 | -23.5 | -38.1 | -48.5 | -60.6 | -28.7 | -43.8 | -55.2 | -64.6 |
,| SKINOREN® | -24.2 | -38.1 | -49.1 | -55.0 | -14.9 | -27.0 | -35.5 | -42.1 | -18.4 | -30.8 | -40.1 | -46.1 |
Number of Participants With Presence of Staphylococcus Aureus After Treatment With Linezolid Versus Clindamycin
Asymptomatic carriage of Staphylococcus aureus at the 40-day visit will be compared in the patients assigned to receive linezolid to the patients assigned to receive clindamycin. (NCT01619410)
Timeframe: 40 days after completion of treatment
| Intervention | Participants (Count of Participants) |
|---|
| Linezolid | 3 |
| Clindamycin | 2 |
Clinical Improvement at the 48-72 Hour Clinical Follow-up
Clinical improvement was defined as improvement in at least one of the following four measures without regression in any: (1) erythema (2) pain (3) induration (4) patient or families self report of improvement. (NCT00352612)
Timeframe: 48-72 hour clinical follow-up
| Intervention | participants (Number) |
|---|
| Cephalexin | 94 |
| Clindamycin | 97 |
Absolute Change in Total Lesion Count From Baseline to Week 12
The assessor performed a count of inflammatory lesions (IL) (papules, pustules, nodules, and cysts), non-inflammatory lesions (NIL) (open and closed comedones) and total lesions (the sum of IL and NIL) at each study visit. Lesion counts were confined to the face. Change from Baseline at Week 12 was calculated as the value at Week 12 minus the value at Baseline. Parameters were estimated using analysis of covariance (ANCOVA) with treatment, center, treatment-by-centre interaction and Baseline lesion count in the model. Missing values were imputed using the last observation carried forward (LOCF), i.e., the last available observation was used to estimate subsequent missing data. (NCT01915732)
Timeframe: Baseline (Week 0) and Week 12
| Intervention | Change in lesion count (Least Squares Mean) |
|---|
| Duac Once Daily Gel | -55.7 |
| Dalin Gel | -51.2 |
| Duac Once Daily Gel | -56.7 |
| Dalin Gel | -52.1 |
Number of Participants Who Had an ISGA Score of 0 or 1 at Week 12
The assessor evaluated the acne severity of the participants' face using the ISGA scale, ranging from 0 to 4: 0=clear skin with no ILs or NILs; 1=almost clear: rare NIL with no more than one small IL; 2=mild, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate, up to many NILs and may have some ILs, but no more than one small NL; 4=severe: up to many NILs and ILs, but no more than a few NLs. Missing values were imputed using the LOCF, i.e., the last available observation was used to estimate subsequent missing data. (NCT01915732)
Timeframe: Week 12
| Intervention | Participants (Number) |
|---|
| Duac Once Daily Gel | 209 |
| Dalin Gel | 151 |
| Duac Once Daily Gel | 196 |
| Dalin Gel | 144 |
Number of Participants With an Improvement of 2 Grades in the Investigator Static Global Assessment (ISGA) Score From Baseline to Week 12
ISGA success is defined as the improvement of 2 grades or more in the participant's acne severity scale at Week 12. Acne severity of the participants' face was assessed by the assessor using the ISGA scale, ranging from 0 to 4: 0=clear skin with no ILs or NILs; 1=almost clear: rare NIL with no more than one small IL; 2=mild, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate, up to many NILs and may have some ILs, but no more than one small NL; 4=severe: up to many NILs and ILs, but no more than a few NLs. Missing values were imputed using the LOCF, i.e., the last available observation was used to estimate subsequent missing data . (NCT01915732)
Timeframe: Baseline (Week 0) and Week 12
| Intervention | Participants (Number) |
|---|
| Duac Once Daily Gel | 142 |
| Dalin Gel | 110 |
Number of Participants With an Improvement of 2 Grades in the Investigator Static Global Assessment (ISGA) Score From Baseline to Week 12
ISGA success is defined as the improvement of 2 grades or more in the participant's acne severity scale at Week 12. Acne severity of the participants' face was assessed by the assessor using the ISGA scale, ranging from 0 to 4: 0=clear skin with no ILs or NILs; 1=almost clear: rare NIL with no more than one small IL; 2=mild, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate, up to many NILs and may have some ILs, but no more than one small NL; 4=severe: up to many NILs and ILs, but no more than a few NLs. Missing values were imputed using the LOCF, i.e., the last available observation was used to estimate subsequent missing data. (NCT01915732)
Timeframe: Baseline (Week 0) and Week 12
| Intervention | Participants (Number) |
|---|
| Duac Once Daily Gel | 151 |
| Dalin Gel | 117 |
Absolute Change in Inflammatory Lesion Counts and Non-inflammatory Lesion Counts From Baseline to Week 12
The assessor performed a count of ILs (papules, pustules, nodules, and cysts), NILs (open and closed comedones at each study visit. Lesion counts were confined to the face. Change from Baseline at Week 12 was calculated as the value at Week 12 minus the value at Baseline. Analysis of covariance (ANCOVA) model was used with terms for Baseline lesion count, treatment, and center. Missing values were imputed using the LOCF, i.e., the last available observation was used to estimate subsequent missing data. (NCT01915732)
Timeframe: Baseline (Week 0) and Week 12
| Intervention | Lesions (Least Squares Mean) |
|---|
| IL | NIL |
|---|
| Duac Once Daily Gel | -20.6 | -35.0 | -20.9 | -35.7 |
Absolute Change in Inflammatory Lesion Counts and Non-inflammatory Lesion Counts From Baseline to Week 12
The assessor performed a count of ILs (papules, pustules, nodules, and cysts), NILs (open and closed comedones at each study visit. Lesion counts were confined to the face. Change from Baseline at Week 12 was calculated as the value at Week 12 minus the value at Baseline. Analysis of covariance (ANCOVA) model was used with terms for Baseline lesion count, treatment, and center. Missing values were imputed using the LOCF, i.e., the last available observation was used to estimate subsequent missing data. (NCT01915732)
Timeframe: Baseline (Week 0) and Week 12
| Intervention | Lesions (Least Squares Mean) |
|---|
| NIL | IL |
|---|
| Dalin Gel | -19.7 | -31.6 | -19.9 | -32.3 |
Percent Change in Inflammatory, Non-inflammatory and Total Lesion Counts From Baseline to Week 12
The assessor performed a count of ILs (papules, pustules, nodules, and cysts), NILs (open and closed comedones) and total lesions (the sum of ILs and NILs)at each study visit. Lesion counts were confined to the face. Change from Baseline at Week 12 was calculated as the value at Week 12 minus the value at Baseline. Analysis of covariance (ANCOVA) model was used with terms for Baseline lesion count, treatment, and center. Missing values were imputed using the LOCF, i.e., the last available observation was used to estimate subsequent missing data. (NCT01915732)
Timeframe: Baseline (Week 0) and Week 12
| Intervention | Percent change in lesions (Least Squares Mean) |
|---|
| IL | NIL | Total |
|---|
| Dalin Gel | -0.75 | -0.60 | -0.67 | -0.76 | -0.61 | -0.68 |
,| Duac Once Daily Gel | -0.78 | -0.67 | -0.72 | -0.80 | -0.70 | -0.74 |
Mean Percent Change From Baseline to Week 11 (Study Day 77) for Inflammatory (Papules and Pustules) Lesions.
"Mean percent change from baseline to week 11 (study Day 77) for inflammatory (papules and pustules) lesions in PP populations. The primary endpoint of the study is mean percent change from baseline to week 11 (study Day 77) in the inflammatory (papules and pustules) lesion count.~Papule was Inflammatory lesion; small (< 5mm in diameter), solid palpable lesion, usually with inflamed elevation of the skin that does not contain pus. Pustule was Inflammatory lesion; small (< 5mm in diameter), inflamed skin swelling that is filled with pus. The test product was judged therapeutically equivalent to the reference product in the reduction of inflammatory lesions if the 90% confidence interval was contained within the interval (0.80, 1.25)" (NCT02005666)
Timeframe: week 11
| Intervention | percentage of mean change from baseline (Mean) |
|---|
| Test-Cadila Healthcare Limited | -67.6 |
| Reference-DUAC® Gel | -71.3 |
| Placebo | -51.9 |
Mean Percent Change From Baseline to Week 11 in the Non-inflammatory Lesion Count
"Mean percent change from baseline to week 11 in the non-inflammatory lesion count. The mean percent change from baseline to week 11 in the non-inflammatory (open and closed comedones) lesion count in per protocol population . The analysis was same as the analysis performed for the mean percent reduction from baseline to Day 77 in the number of inflammatory lesion count.~Closed Comedone was Non-inflammatory lesion; whitehead, skin-colored or slightly inflamed bump in the skin. Open Comedone was Non-inflammatory lesion; blackhead, surface of the plugged sebaceous follicle has a blackish appearance. The test product was judged therapeutically equivalent to the reference product in the reduction of Non inflammatory lesions if the 90% confidence interval was contained within the interval (0.80, 1.25)" (NCT02005666)
Timeframe: week 11
| Intervention | percentage of change (Mean) |
|---|
| Test-Cadila Healthcare Limited | -61.7 |
| Reference-DUAC® Gel | -61.3 |
| Placebo | -42.0 |
Mean Percent Change in the Number of Inflamed Lesions (Papules/Pustules)
The number of inflammatory lesions (papules and pustules) count between the treatment groups were estimated. (NCT02465632)
Timeframe: Baseline and 10 Weeks
| Intervention | percentage change from baseline (Mean) |
|---|
| Test | 72.3 |
| Reference | 71.1 |
| Placebo | 39.1 |
Mean Percent Change in the Number of Non-inflamed Lesions (Open and Closed Comedones)
The number of non-inflamed lesions (open and closed comedones) count between treatment groups were estimated. (NCT02465632)
Timeframe: Baseline and 10 Weeks
| Intervention | Percentage change from baseline (Mean) |
|---|
| Test | 64.5 |
| Reference | 63.3 |
| Placebo | 30.9 |
Number of Participants (Par.) Achieving Clinical Success (CS) (Cure or Improvement [Imp] in Signs [s] and Symptoms [sx] [s/sx]) Without Considering Clinical (cl) Judgment (Jdg) of the Investigator (Inv) at Day 5
CS is defined as cure or imp in s/sx of odontogenic infections. Cure is defined as the complete resolution of s/sx of infection present at Baseline (BL) and imp is defined as resolution of fever (if present at BL), >70% reduction in swelling and pain and imp in other s/sx such that no additional antimicrobial (ant) therapy is required. In event of cure or imp with complete resolution of fever and >70% reduction in swelling and pain, but 'no change' or 'worsening from BL' in other s/sx (like increased leucocyte count/tooth mobility), the inv's opinion was sought on whether additional ant therapy was required. Par. that required no additional ant therapy were considered a 'success' while those requiring additional ant therapy were deemed a 'failure'. For a sensitivity analysis, all such par. with 'no change' or 'worsening from BL' in these other s/sx were considered as cl failures and termed 'Without Considering Cl Jdg of Inv', even though main s/sx are 'cured' or 'improved'. . (NCT02141217)
Timeframe: Day 5
| Intervention | Participants (Number) |
|---|
| Amoxicillin 875 mg + Clavulanic Acid 125 mg | 158 |
| Clindamycin 150 mg | 150 |
Number of Participants Achieving Clinical Success (Cure or Improvement) Considering Clinical Judgment of the Investigator at Day 5
Clinical success is defined as the achievement of cure or improvement in signs and symptoms of odontogenic infections. Cure is defined as the complete resolution of signs and symptoms of infection present at baseline, such that no additional antimicrobial therapy is required. Improvement is defined as the resolution of fever (if present at baseline), >70% reduction in swelling and pain and improvement in other signs and symptoms such that no additional antimicrobial therapy is required. Visual Analogue Scale (VAS) is used to measure the amount of pain and swelling that a participant experiences. This scale has numerical ratings from 0 to 10. Zero indicates no pain and 10 indicates worst possible pain. (NCT02141217)
Timeframe: Day 5
| Intervention | Participants (Number) |
|---|
| Amoxicillin 875 mg + Clavulanic Acid 125 mg | 169 |
| Clindamycin 150 mg | 159 |
Percentage of Participants Achieving Clinical Success (Cure or Improvement) Considering Clinical Judgment of the Investigator at the End of Treatment (Day 5 or Day 7)
Clinical success is defined as the achievement of cure or improvement in signs and symptoms of odontogenic infections. Cure is defined as the complete resolution of signs and symptoms of infection present at baseline, such that no additional antimicrobial therapy is required. Improvement is defined as the resolution of fever (if present at baseline), >70% reduction in swelling and pain and improvement in other signs and symptoms such that no additional antimicrobial therapy is required. Visual Analogue Scale (VAS) is used to measure the amount of pain and swelling that a participant experiences. This scale has numerical ratings from 0 to 10. Zero indicates no pain and 10 indicates worst possible pain. (NCT02141217)
Timeframe: Day 5 or Day 7 [End of treatment]
| Intervention | Percentage of participants (Number) |
|---|
| Amoxicillin 875 mg + Clavulanic Acid 125 mg | 88.2 |
| Clindamycin 150 mg | 89.7 |
| Amoxicillin 875 mg + Clavulanic Acid 125 mg | 85.5 |
| Clindamycin 150 mg | 86.4 |
| Amoxicillin 875 mg + Clavulanic Acid 125 mg | 83.3 |
| Clindamycin 150 mg | 85.7 |
Change From Baseline in the Visual Analogue Scale Assessment of Pain Score at Days 2, 5 and 7
Visual Analogue Scale (VAS) is used to measure the amount of pain that the participant experiences. This scale has numerical ratings from 0 to 10. Zero indicates no pain and 10 indicates worst possible pain. Change in Pain/Swelling is calculated as VAS score at Baseline minus the score at a later time point (Day 2, 5 or 7). (NCT02141217)
Timeframe: Baseline, Days 2, 5 and 7
| Intervention | Scores on a scale (Least Squares Mean) |
|---|
| Day 2, n=227, 233 | Day 5, n=219, 228 | Day 7, n=57, 71 |
|---|
| Amoxicillin 875 mg + Clavulanic Acid 125 mg | 3.34 | 5.49 | 6.38 |
,| Clindamycin 150 mg | 3.07 | 5.38 | 6.34 |
Change From Baseline in Visual Analogue Scale Assessment of Swelling at Days 2, 5 and 7
Visual Analogue Scale (VAS) is used to measure the amount of swelling that the participant experiences. This scale has numerical ratings from 0 to 10. Zero indicates no swelling and 10 indicates worst possible swelling. Change in Pain/Swelling is calculated as VAS score at Baseline minus the score at a later time point (Day 2, 5 or 7). (NCT02141217)
Timeframe: Baseline, Days 2, 5 and 7
| Intervention | Scores on a scale (Least Squares Mean) |
|---|
| Day 2, n=219, 225 | Day 5, n=214, 223 | Day 7, n=55, 68 |
|---|
| Amoxicillin 875 mg + Clavulanic Acid 125 mg | 1.92 | 3.68 | 4.21 |
,| Clindamycin 150 mg | 1.61 | 3.60 | 4.61 |
Number of Participants With Both a Clinical and a Bacteriological Cure (Nugent Score <4), Evaluated at Visit 2 Test-of-cure (Study Day 22-30).
"Clinical Cure is defined as resolution of clinical signs and symptoms from entry visit as follows:~The original discharge characteristic of bacterial vaginosis has returned to a normal physiological vaginal discharge which varies in appearance and consistency depending on the menstrual cycle,~The whiff test is negative for any amine (fishy) odor,~The saline wet mount is negative for clue cells,~Vaginal fluid pH is < 4.7, using pH paper that measures from 3.6 to 6.1.~A Bacteriological cure is defined as a Nugent score < 4.~The system used a 0-4 scale (Nugent Scoring System 0-10 for Gram-Stained Vaginal Smears) for evaluation of vaginal flora, based on the weighted sum of the following 3 bacterial morphotypes scores calculated from slide examination under oil immersion field:~Lactobacillus: large gram positive rods,~Gardnerella / Bacteroides spp: Small gram variable coccobacilli/small Gram negative rods,~Mobiluncus spp.: thin, curved Gram variable rods" (NCT02210689)
Timeframe: 22 to 30 days
| Intervention | Participants (Count of Participants) |
|---|
| Test Product | 36 |
| Reference Product | 34 |
| Placebo | 9 |