clobetasol and Pain

Topical corticosteroids (TCS) are the mainstay of psoriasis treatment. Safety concerns may limit use. Combination with tazarotene may optimize efficacy and minimize safety and tolerability concerns.. Investigate safety and efficacy of halobetasol propionate 0.01%/tazarotene 0.045% (HP/TAZ) lotion in moderate-to-severe plaque psoriasis.. Two multicenter, randomized, double-blind, vehicle-controlled phase 3 studies (N=418). Subjects randomized (2:1) to HP/TAZ lotion or vehicle once-daily for 8 weeks, 4-week follow-up. Primary efficacy assessment: treatment success (at least a 2-grade improvement from baseline in IGA score and 'clear' or 'almost clear'). Safety and treatment emergent AEs evaluated throughout.. HP/TAZ lotion demonstrated statistically significant superiority over vehicle as early as week 2 (P equals 0.002). By week 8, 40.6% of subjects were treatment successes compared with 9.9% on vehicle (P less than 0.001). A third of subjects remained treatment successes post-treatment. HP/TAZ lotion was also superior in reducing psoriasis signs and symptoms, and Body Surface Area (BSA) involvement. Most frequently reported treatment related AEs were contact dermatitis (6.3%), application site pain (2.6%), and pruritus (2.2%).. No data were collected beyond the 4-week follow-up.. HP/TAZ lotion provides synergistic efficacy that is both rapid and sustained, with good tolerability and safety over 8 weeks use. J Drugs Dermatol. 2018;17(8):855-861.

Topics: Clinical Trials, Phase III as Topic; Clobetasol; Dermatitis; Dermatologic Agents; Drug Combinations; Female; Humans; Male; Multicenter Studies as Topic; Nicotinic Acids; Pain; Psoriasis; Randomized Controlled Trials as Topic; Severity of Illness Index; Skin Cream; Treatment Outcome

Amlexanox appears to be most effective overall. Amlexanox 5% paste reduces ulcer size, pain duration, and healing time.

Topics: Administration, Topical; Aminopyridines; Anti-Allergic Agents; Anti-Infective Agents, Local; Anti-Inflammatory Agents; Beclomethasone; Cautery; Clobetasol; Eupatorium; Humans; Mouthwashes; Pain; Phytotherapy; Plant Preparations; Secondary Prevention; Stomatitis, Aphthous; Vitamin B 12

Topics: Adult; Anti-Inflammatory Agents; Clobetasol; Double-Blind Method; Female; Humans; Lacticaseibacillus rhamnosus; Male; Middle Aged; Pain; Patient Satisfaction; Probiotics; Quality of Life; Stomatitis, Aphthous; Surveys and Questionnaires; Young Adult

Previous results from two phase 3 studies demonstrated efficacy and safety of fixed combination halobetasol propionate 0.01%/tazarotene 0.045% (HP/TAZ) lotion in participants with moderate-to-severe plaque psoriasis. This post hoc analysis evaluated sex-specific efficacy and safety of HP/TAZ lotion.. In two randomized, double-blind, phase 3 studies, participants were randomized (2:1) to receive HP/TAZ or vehicle lotion once daily for 8 weeks. Male and female participants were evaluated separately in this pooled analysis. Efficacy assessments included treatment success (at least 2‑grade improvement in Investigator's Global Assessment [IGA] score and score of clear/almost clear), impact on individual signs of psoriasis, and affected Body Surface Area (BSA).. The analysis included 272 males (HP/TAZ, n=175; vehicle, n=97) and 146 females (HP/TAZ, n=101; vehicle, n=45). Significantly more participants achieved overall treatment success at week 8 with HP/TAZ versus vehicle in both male (38.4% vs 9.8%) and female (44.5% vs 9.9%) subgroups (P<0.001, both). Erythema, plaque elevation, and scaling were also reduced by week 8 in both males and females, with significantly more HP/TAZ-treated participants achieving at least 2‑grade improvement in each sign of psoriasis than vehicle-treated participants (P<0.001 each, both groups). Mean reductions in affected BSA were significantly greater with HP/TAZ versus vehicle lotion in both males and females (P≤0.001, both). The most frequent treatment-related adverse events were contact dermatitis, pruritis, and application site pain (each 4.0%) in females and contact dermatitis (7.6%) in males.. HP/TAZ lotion was highly effective and safe in both males and females with moderate-to-severe psoriasis over 8 weeks of once-daily use. J Drugs Dermatol. 2020;19(5): doi:10.36849/JDD.2020.5021.

Topics: Adult; Aged; Clobetasol; Dermatitis, Contact; Double-Blind Method; Drug Combinations; Female; Humans; Male; Middle Aged; Nicotinic Acids; Pain; Pruritus; Psoriasis; Severity of Illness Index; Sex Factors; Skin Cream; Treatment Outcome

Background: The use of topical therapy is a key component in the management of almost all psoriasis patients. Topicals are considered first-line therapy for mild disease and are having an increasing role in moderate or severe psoriasis as an integral part of combination therapy. Halobetasol has been shown be effective in moderate or severe localized plaque psoriasis, and tazarotene affords important effects on epidermal hyperproliferation that may be important in more severe disease.\ \ Objective: To investigate the efficacy, safety and tolerability of a once-daily application of a fixed combination halobetasol propionate 0.01% and tazarotene 0.045% (HP/TAZ) lotion in comparison with its vehicle in patients with severe localized plaque psoriasis (as defined by an Investigator Global Assessment (IGA) of 4 and Body Surface Area (BSA) of 3%-12%.\ \ Methods: Post hoc analysis of two multicenter, randomized, double-blind, vehicle-controlled phase 3 studies. Sixty-two patients with severe localized psoriasis (mean BSA 7.4) randomized (2:1) to receive HP/TAZ lotion or vehicle, once-daily for 8 weeks, with a 4-week posttreatment follow-up. Efficacy assessments included treatment success (defined as at least a 2-grade improvement from baseline in the IGA score and a score of ‘clear’ or ‘almost clear’), impact on individual signs of psoriasis (erythema, plaque elevation, and scaling) at the target lesion, BSA, reduction in mean baseline IGAxBSA and achievement of a clinically meaningful response (number of patients who achieved at least a 75% improvement in IGAxBSA). Safety and treatment emergent adverse events (TEAEs) were evaluated throughout.\ \ Results: By week 8, 34.8% of patients were treatment successes compared with 0.0% on vehicle (P=0.004). HP/TAZ lotion was also significantly superior in reducing psoriasis signs and symptoms and improving BSA. At week 8, 47.4% (erythema), 66.4% (plaque elevation), and 65.4% (scaling) subjects achieved at least a 2-grade improvement, compared with 14.0% (P=0.016), 14.8% (P<0.001) and 14.7% (P<0.001) respectively with vehicle. Patients treated with HP/TAZ lotion achieved a 32.8% reduction in baseline mean BSA, compared with a 39.6% increase with vehicle (P=0.013). HP/TAZ lotion achieved a statistically significant superior reduction in mean IGAxBSA compared to vehicle from week 2 (P<0.001 versus vehicle). By week 8, almost half of the patients treated with HP/TAZ lotion achieved a clinically meaningful response (IGAxBSA-75) and

Topics: Adult; Clobetasol; Dermatitis, Contact; Dermatologic Agents; Double-Blind Method; Drug Combinations; Female; Humans; Male; Middle Aged; Nicotinic Acids; Pain; Pruritus; Psoriasis; Severity of Illness Index; Skin Cream; Treatment Outcome

Ingenol mebutate (IngMeb) is approved for treatment of actinic keratoses (AK) and may cause unpredictable local skin responses (LSR).. We sought to investigate whether IngMeb-induced LSR, pain, and pruritus could be alleviated with a topical glucocorticoid and, further, to assess efficacy, cosmetic outcome, and patient satisfaction in patients with severe photodamage.. In this blinded, randomized controlled clinical trial, patients with multiple AK and field cancerization of the face or scalp were treated in 2 areas with IngMeb (0.015%) daily for 3 days. After finalized IngMeb treatment, 1 area was randomized to receive topical clobetasol propionate (0.05%) twice daily for 4 days. Assessments included LSR (0-24; days 1, 4, 8, 15, 57), pain (0-10) and pruritus (0-3; days 1-15), AK clearance (days 15, 57), and cosmetic outcome (0-3; day 57).. Clobetasol propionate application had no influence on LSR (P = .939), pain (P = .500), pruritus (P = .312), or AK cure rate (P = .991). Overall, IngMeb cleared 86% of all AK lesions, exerting a therapeutic effect on all AK severity grades; cure rates were 88%, 70%, and 60% for grade I, II, and III AK, respectively. Skin texture improved significantly in remedied areas (2.0 vs 1.0; P < .001); no hypopigmentation, hyperpigmentation, or scarring were observed.. These results do not provide safety and efficacy beyond 2 months of follow-up.. Application of clobetasol propionate does not alleviate IngMeb-induced LSR after 3 days of IngMeb treatment.

Topics: Administration, Topical; Adrenal Cortex Hormones; Aged; Aged, 80 and over; Clobetasol; Denmark; Diterpenes; Dose-Response Relationship, Drug; Drug Administration Schedule; Drug Therapy, Combination; Facial Dermatoses; Female; Follow-Up Studies; Gels; Humans; Keratosis, Actinic; Male; Middle Aged; Pain; Pruritus; Risk Assessment; Scalp Dermatoses; Severity of Illness Index; Single-Blind Method; Treatment Outcome

Photodynamic therapy (PDT) is an effective and established treatment for actinic keratoses (AK) and nonmelanoma skin cancer. The main side-effects of PDT are post-treatment erythema and oedema, and pain during illumination. Severe erythema after PDT enhances the down time associated with the treatment.. To evaluate in a randomized intraindividual study whether use of a topical corticosteroid just before and just after PDT would reduce treatment-induced erythema compared with conventional PDT.. Twenty-two patients with multiple AKs in the face and scalp were treated with methyl aminolaevulinate PDT in two symmetrical areas. One area was randomized to superpotent corticosteroid (clobetasol propionate) before and just after PDT. Objective and visual erythema, protoporphyrin IX (PpIX) fluorescence and pain were evaluated.. Topical corticosteroid significantly reduced PDT-induced erythema (P = 0·012). The complete lesion response rate 3 months after PDT, and PpIX fluorescence prior to illumination did not differ significantly between the two treated areas.. Superpotent corticosteroid before and just after PDT reduced the erythema 24 h after treatment of multiple AKs on the face and scalp. The use of topical corticosteroid did not affect the efficacy of PDT and may be an easy way to make PDT treatment of large visible areas more acceptable.

Topics: Administration, Cutaneous; Aged; Aged, 80 and over; Aminolevulinic Acid; Anti-Inflammatory Agents; Clobetasol; Erythema; Facial Dermatoses; Female; Fluoroscopy; Glucocorticoids; Humans; Keratosis, Actinic; Male; Pain; Photochemotherapy; Photosensitizing Agents; Protoporphyrins; Scalp Dermatoses; Treatment Outcome

Topics: Administration, Cutaneous; Adult; Analysis of Variance; Anti-Inflammatory Agents; Clobetasol; Double-Blind Method; Female; Glucocorticoids; Histamine; Humans; Male; Ointments; Pain; Pain Threshold; Placebos; Pruritus; Sensory Thresholds; Thermosensing

We have studied the antinociceptive and anti-inflammatory effects of topical glucocorticoids in human thermal injury. The right and left legs of 12 healthy volunteers were allocated randomly to be treated with either 0.05% clobetasol propionate cream or placebo in a double-blind trial. Thermal injuries were induced with a thermode, which was heated to 49 degrees C for 5 min under standardized pressure. Clobetasol propionate or placebo cream was applied to the skin 1 h before burn injury, immediately after the injury and every 12 h for the next 3 days. Heat pain detection thresholds (HPDT), heat pain tolerance (HPT), mechanical pain detection thresholds (MPDT) and the intensity of burn-induced erythema (erythema index, EI) were assessed inside the thermal injury and areas of hyperalgesia to pinprick outside the injury were determined before and regularly for 72 h after the burn injury. Burn injury caused a decrease in HPDT, HPT and MPDT, an increase in EI and development of mechanical, secondary hyperalgesia. Clobetasol propionate had no effect on any of the nociceptive or inflammatory variables studied.

Topics: Adult; Burns; Clobetasol; Double-Blind Method; Erythema; Female; Humans; Male; Pain; Pain Measurement; Pain Threshold; Skin; Time Factors

Scoring systems have been widely used to evaluate the severity and activity of oral lichen planus (OLP). The aim of the present study was to compare two existing (one modified) scoring systems in the evaluation of OLP severity and correlation with pain. Three differently experienced raters were involved.. Consecutive patients with OLP were assessed for pain using the Visual Analogue Scale and examined at 10 intraoral sites before starting (T0) and three weeks after (T1) steroid therapy (Clobetasol). Three differently experienced raters evaluated photographs using two scoring systems designated White-Erosive-Atrophic (WEA) modified from an older WEA system (WEA-MOD) and Reticular-erythematous-Ulcerative (REU) systems. WEA-MOD Kendall's W and interclass correlation coefficient were calculated and correlation between REU/WEA-MOD and pain was calculated using Spearman coefficient.. Most patients showed lesions on buccal mucosa (85-93,5%) and maxillary/mandibular gingivae (31,8-31,2%), predominantly reticular. At T0, Kendall-W coefficients of 0.89 and 0.74 were obtained for the REU and WEA respectively. At T1, Kendall-W coefficients of 0.83 and 0.58 were obtained for the REU and WEA respectively. Interclass correlation coefficient ranged from 0.87 to 0.90 for REU and from 0.58 to 0.87 for WEA. REU and WEA scores significantly decreased after therapy (p<0.000) as well as VAS (p<0.05). REU score showed correlation with VAS.. All the raters achieved comparable measures using REU whereas WEA and WEA-MOD seem less reproducible. REU seems to correlate to disease activity and pain.

Topics: Clobetasol; Female; Glucocorticoids; Humans; Lichen Planus, Oral; Male; Middle Aged; Pain; Pain Measurement; Severity of Illness Index

To evaluate topical treatment with clobetasol propionate and lidocaine in women with urethral pain syndrome (UPS) in a retrospective pilot study.. Urethral instillations of two ml clobetasol propionate cream and two ml lidocaine gel in 30 Caucasian women age 15-74 years with UPS between 1999 and 2006 were evaluated retrospectively. Instillations were given ap- proximately once a week until the patient improved. Between one and 15 (median three) instillations were given. In substudy I a review was undertaken of the medical records to register the treatment effect at the end of the treatment (the last instillation) and any relapses six months thereafter. Substudy II was a follow-up at least five years after last instillation based on medical records and a written ques- tionnaire.. Substudy I (n=30): By the end of the treatment 18 women had no symptoms and 12 were improved. Five patients had relapsed within six months. Substudy II (n=28): Twenty-eight women responded to the questionnaire. Four women remained with no symptoms, 18 remained improved, and six had the same symptoms as before treatment. Twenty women thought the treatment was very effective, five rather effective, and three women reported poor effect. Twenty-six women would ask for retreatment if a relapse oc- curred, two patients would not. No side effects, except transient pain, were reported.. This retrospective study and long- term follow-up suggests that urethral instillation of clobetasol propionate and lidocaine is effective in treating women with UPS. Randomized control studies are warranted.

Topics: Administration, Topical; Adolescent; Adult; Aged; Anesthetics, Local; Clobetasol; Female; Glucocorticoids; Humans; Lidocaine; Middle Aged; Pain; Pilot Projects; Retrospective Studies; Syndrome; Treatment Outcome; Urethra; Young Adult

Topics: Anesthetics, Local; Anti-Inflammatory Agents; Child; Clobetasol; Diagnosis, Differential; Female; Fever; Genital Diseases, Female; Genitalia, Female; Humans; Lidocaine; Pain; Ulcer

A man, 58 years of age, presented with a 4 year history of painful lesions of his nails. His previous history included hypertension, diabetes mellitus and hyperlipidaemia. These were treated with enalapril, metformin and simvastatin respectively. He also had asymptomatic skin lesions for over 15 years that had worsened in the past 4 years. His father had similar nail lesions that had been diagnosed as onychomycosis.

Topics: Clobetasol; Dermatologic Agents; Glucocorticoids; Humans; Male; Methotrexate; Middle Aged; Nail Diseases; Onycholysis; Pain; Psoriasis; PUVA Therapy

Acute generalized exanthematous pustulosis (AGEP) is a febrile pustular drug eruption. Terbinafine, an allylamine fungicidial agent, is the most common anti-mycotic associated with AGEP. Here, we report a case of terbinafine-induced AGEP that was recalcitrant to oral corticosteroid but responsive to high-dose intravenous corticosteroid.

Topics: Acute Generalized Exanthematous Pustulosis; Anti-Inflammatory Agents; Antifungal Agents; Clobetasol; Diphenhydramine; Fatigue; Female; Humans; Immunosuppressive Agents; Infusions, Intravenous; Methylprednisolone; Middle Aged; Naphthalenes; Onychomycosis; Pain; Prednisone; Terbinafine