lidocaine has been researched along with Skin Aging in 77 studies
Lidocaine: A local anesthetic and cardiac depressant used as an antiarrhythmia agent. Its actions are more intense and its effects more prolonged than those of PROCAINE but its duration of action is shorter than that of BUPIVACAINE or PRILOCAINE.
lidocaine : The monocarboxylic acid amide resulting from the formal condensation of N,N-diethylglycine with 2,6-dimethylaniline.
Skin Aging: The process of aging due to changes in the structure and elasticity of the skin over time. It may be a part of physiological aging or it may be due to the effects of ultraviolet radiation, usually through exposure to sunlight.
Excerpt | Relevance | Reference |
---|---|---|
"Lidocaine/tetracaine 7%/7% peel cream (L/T-pC) is very effective in reducing pain in several dermatological procedures, such as hair or tattoo laser removal or conventional photodynamic therapy associated pain." | 9.51 | Assessment of clinical efficacy of lidocaine/tetracaine 7%/7% peel cream in fractional microablative laser procedure-associated pain for facial skin aging treatment. A randomized, controlled, single-blind trial. ( Caprari, E; Milani, M; Viciguerra, MT, 2022) |
"2% of subjects who were treated with HAF-Lidocaine reported reduced pain when compared with those who were treated with HAF and the mean VAS score difference was 38." | 9.34 | Reduced pain with injection of hyaluronic acid with pre-incorporated lidocaine for nasolabial fold correction: A multicenter, double-blind, randomized, active-controlled, split-face designed, clinical study. ( Choi, SY; Han, HS; Kim, BJ; Lee, JS; Lee, YW; Yoo, KH, 2020) |
"The investigators explored the severity of bruising and pain in patients treated with the cohesive polydensified matrix HA (CPMHA) in 3 different preparations: CPMHA (Belotero Balance [BEL]), CPMHA with lidocaine (BEL-L), and CPMHA with lidocaine and epinephrine (BEL-LE)." | 9.20 | A blinded, randomized, split-face pilot study of bruising and pain with hyaluronic acid for correction of perioral lines using no lidocaine, lidocaine alone, and lidocaine and epinephrine. ( Howell, DJ; Moradi, A; Moradi-Poehler, J; Shirazi, A; Turner, J, 2015) |
"The addition of lidocaine substantially reduces the pain of LGP-HA injection without altering safety." | 9.14 | A lidocaine-containing formulation of large-gel particle hyaluronic acid alleviates pain. ( Bank, D; Brandt, F; Cross, SL; Weiss, R, 2010) |
"Pain was evaluated using a visual analog scale." | 6.78 | The evaluation of hyaluronic acid, with and without lidocaine, in the filling of nasolabial folds as measured by ultrastructural changes and pain management. ( Cornejo, P; Cruz, I; Isarría, MJ; Moreno-Moraga, J; Muñoz, E; Pérez, G; Royo de la Torre, J, 2013) |
"Two randomized, double-blinded, split-face trials aimed to demonstrate noninferiority of specific hyaluronic acid fillers incorporating mepivacaine (RHA-M) versus their lidocaine controls, at providing pain relief." | 5.51 | Patient Comfort, Safety, and Effectiveness of Resilient Hyaluronic Acid Fillers Formulated With Different Local Anesthetics. ( Dayan, SH; Eaton, L; Joseph, JH; Kaufman-Janette, J; Maffert, P; Smith, S, 2022) |
"Lidocaine/tetracaine 7%/7% peel cream (L/T-pC) is very effective in reducing pain in several dermatological procedures, such as hair or tattoo laser removal or conventional photodynamic therapy associated pain." | 5.51 | Assessment of clinical efficacy of lidocaine/tetracaine 7%/7% peel cream in fractional microablative laser procedure-associated pain for facial skin aging treatment. A randomized, controlled, single-blind trial. ( Caprari, E; Milani, M; Viciguerra, MT, 2022) |
"2% of subjects who were treated with HAF-Lidocaine reported reduced pain when compared with those who were treated with HAF and the mean VAS score difference was 38." | 5.34 | Reduced pain with injection of hyaluronic acid with pre-incorporated lidocaine for nasolabial fold correction: A multicenter, double-blind, randomized, active-controlled, split-face designed, clinical study. ( Choi, SY; Han, HS; Kim, BJ; Lee, JS; Lee, YW; Yoo, KH, 2020) |
"The investigators explored the severity of bruising and pain in patients treated with the cohesive polydensified matrix HA (CPMHA) in 3 different preparations: CPMHA (Belotero Balance [BEL]), CPMHA with lidocaine (BEL-L), and CPMHA with lidocaine and epinephrine (BEL-LE)." | 5.20 | A blinded, randomized, split-face pilot study of bruising and pain with hyaluronic acid for correction of perioral lines using no lidocaine, lidocaine alone, and lidocaine and epinephrine. ( Howell, DJ; Moradi, A; Moradi-Poehler, J; Shirazi, A; Turner, J, 2015) |
"The dermal filler formulated with lidocaine is effective in reducing procedural pain during correction of facial wrinkles and folds while maintaining a similar safety and effectiveness profile to the filler without lidocaine." | 5.14 | A multi-center, double-blind, randomized controlled study of the safety and effectiveness of Juvéderm injectable gel with and without lidocaine. ( Bank, DE; Boyd, CM; Gold, MH; Murphy, DK; Thomas, JA; Weinkle, SH, 2009) |
"The addition of lidocaine substantially reduces the pain of LGP-HA injection without altering safety." | 5.14 | A lidocaine-containing formulation of large-gel particle hyaluronic acid alleviates pain. ( Bank, D; Brandt, F; Cross, SL; Weiss, R, 2010) |
"Although the benefits of adding lidocaine are recognized in terms of relieving the pain experienced upon injection, it would appear beneficial to establish the impact of lidocaine within the Stylage® range, the only one to incorporate both an anaesthetic (lidocaine) and an antioxidant in the form of mannitol in its crosslinked gel of HA." | 3.77 | Benefits of adding lidocaine to a hyaluronic gel - Stylage® M. ( Gozlan, L; Mole, B, 2011) |
"This study demonstrates that calcium hydroxylapatite is effective and safe for restoration and augmentation of the jawline using the unique needle and cannula technique." | 3.11 | A Randomized, Evaluator-Blind, Split-Face Study Evaluating the Safety and Efficacy of Calcium Hydroxylapatite for Jawline Augmentation. ( Alhaddad, M; Boen, M; Goldman, MP; Hoss, E; Kollipara, R; Wu, DC, 2022) |
" The study demonstrated a favorable safety profile, with no reported unexpected adverse events." | 3.01 | Effectiveness and Safety of Calcium Hydroxylapatite With Lidocaine for Improving Jawline Contour. ( Cohen, J; Dakovic, R; Green, J; Joseph, J; Moradi, A; Odena, G; Scher, R; Verma, A, 2021) |
" A total of 29 treatment related adverse events were reported by 16% of subjects, all were mild (79%) or moderate (21%) in intensity." | 2.94 | Safety and Effectiveness of Hyaluronic Acid Fillers With Lidocaine for Full-Face Treatment in Asian Patients. ( Huang, SH; Tsai, TF, 2020) |
"VYC-25L significantly improved glabella-subnasale-pogonion facial angle and was generally safe and well tolerated." | 2.90 | Safe, Effective Chin and Jaw Restoration With VYC-25L Hyaluronic Acid Injectable Gel. ( Abrams, S; Belhaouari, L; Chawla, S; Gaymans, F; Ogilvie, P; Sattler, G; Schumacher, A; Snow, S; Weichman, BM, 2019) |
" Both HA IDF plus and HA IDF were considerably tolerated and most adverse reactions were mild and transient." | 2.84 | The Efficacy and Safety of HA IDF Plus (with Lidocaine) Versus HA IDF (Without Lidocaine) in Nasolabial Folds Injection: A Randomized, Multicenter, Double-Blind, Split-Face Study. ( Kim, SH; Lee, JH; Park, ES, 2017) |
" Both fillers were well tolerated, and adverse reactions were mild." | 2.84 | A multicenter, randomized, double-blind clinical study to evaluate the efficacy and safety of a new monophasic hyaluronic acid filler with lidocaine 0.3% in the correction of nasolabial fold. ( Im, SI; Kim, BJ; Lee, JH; Lim, JS; Oh, CT; Suh, JH, 2017) |
" Most reported adverse events (80%) were mild in severity." | 2.82 | Effectiveness and Safety of Large Gel Particle Hyaluronic Acid With Lidocaine for Correction of Midface Volume Deficit or Contour Deficiency. ( Bank, D; Dover, J; Few, J; Joseph, J; Lin, X; Mashburn, J; Moradi, A; Nogueira, A; Weiss, RA, 2016) |
" Most common treatment-emergent adverse events (AEs) included lip bruising, swelling, and pain and were mostly mild and transient in nature, without anticipated device AEs." | 2.80 | A randomized, evaluator-blinded, controlled study of effectiveness and safety of small particle hyaluronic acid plus lidocaine for lip augmentation and perioral rhytides. ( Beer, K; Bulley, B; Dover, JS; Glogau, RG; Handiwala, L; Olin, JT; Shamban, A, 2015) |
" The second validity evaluation variable including the global aesthetic improvement scale (GAIS), the WSRS, and adverse event reporting at weeks 8, 16, and 24 were also performed." | 2.80 | The Efficacy and Safety of Lidocaine-Containing Hyaluronic Acid Dermal Filler for Treatment of Nasolabial Folds: A Multicenter, Randomized Clinical Study. ( Choi, WJ; Han, SW; Kang, H; Kim, HW; Kim, JE; Kim, MB, 2015) |
"Pain and potential adverse events (AE) remain challenges for patients being treated with calcium hydroxylapatite (CaHA; Radiesse), especially CaHA not mixed with an anesthetic." | 2.79 | Safety and effectiveness of injection of calcium hydroxylapatite via blunt cannula compared to injection by needle for correction of nasolabial folds. ( Beer, KR, 2014) |
"Pain was evaluated using a visual analog scale." | 2.78 | The evaluation of hyaluronic acid, with and without lidocaine, in the filling of nasolabial folds as measured by ultrastructural changes and pain management. ( Cornejo, P; Cruz, I; Isarría, MJ; Moreno-Moraga, J; Muñoz, E; Pérez, G; Royo de la Torre, J, 2013) |
"Data from this study demonstrate that topical anesthetic for facial rejuvenation can be enhanced with laser pretreatment while maintaining safe blood serum levels." | 2.78 | Topical lidocaine enhanced by laser pretreatment: a safe and effective method of analgesia for facial rejuvenation. ( Kenkel, J; Oni, G; Rasko, Y, 2013) |
" No adverse events related to systemic toxicity were observed or reported to the nurse." | 2.75 | Safety of lidocaine 15% and prilocaine 5% topical ointment used as local anesthesia for intense pulsed light treatment. ( Carruthers, JA; Carruthers, JD; Mordaunt, J; Oliff, HS; Poirier, J; Schreiber, WE, 2010) |
"Scarring was not observed." | 2.71 | Full-face laser resurfacing using a supplemented topical anesthesia protocol. ( Calkin, J; Chotzen, V; Kilmer, SL; McClaren, M; No, D; Silva, S; Zelickson, BD, 2003) |
" Adverse events were recorded." | 1.51 | Open-Label, Post-Marketing Study to Evaluate the Performance and Safety of Calcium Hydroxylapatite With Integral Lidocaine to Correct Facial Volume Loss ( Muti, GF, 2019) |
" These results show that CaHA (+) is an effective and safe option to correct temporal fossae volume loss associated with high patient satisfaction." | 1.48 | Pilot Study Examining the Safety and Efficacy of Calcium Hydroxylapatite Filler With Integral Lidocaine Over a 12-Month Period to Correct Temporal Fossa Volume Loss. ( Juhász, MLW; Levin, MK; Marmur, ES, 2018) |
"The Safety of Microfocused Ultrasound with Visualization (MFU-V) has been well established in both controlled clinical studies and in clinical use, showing only mild and transient anticipated side effects and only rare unanticipated adverse events (AEs)." | 1.40 | Review of the safety profile for microfocused ultrasound with visualization. ( Dobke, MK; Hitchcock, TM, 2014) |
Timeframe | Studies, this research(%) | All Research% |
---|---|---|
pre-1990 | 0 (0.00) | 18.7374 |
1990's | 2 (2.60) | 18.2507 |
2000's | 12 (15.58) | 29.6817 |
2010's | 45 (58.44) | 24.3611 |
2020's | 18 (23.38) | 2.80 |
Authors | Studies |
---|---|
Jones, D | 2 |
Baumann, L | 2 |
Moradi, A | 4 |
Shridharani, S | 1 |
Palm, M | 2 |
Teller, C | 1 |
Taylor, M | 1 |
Kontis, TC | 1 |
Chapas, A | 2 |
Kaminer, MS | 1 |
Bank, D | 4 |
Beer, K | 2 |
Hooper, D | 1 |
Green, J | 1 |
Cohen, J | 1 |
Joseph, J | 2 |
Dakovic, R | 1 |
Odena, G | 1 |
Verma, A | 1 |
Scher, R | 1 |
Xie, Y | 1 |
Wu, W | 1 |
Xu, J | 1 |
Wang, X | 2 |
Hu, Z | 1 |
Li, Q | 1 |
Lin, JY | 1 |
Lin, CY | 1 |
Pavicic, T | 1 |
Sattler, G | 3 |
Fischer, T | 2 |
Dirschka, T | 1 |
Kerscher, M | 1 |
Gauglitz, G | 2 |
Dersch, H | 1 |
Kravtsov, M | 1 |
Heide, I | 1 |
Prager, W | 2 |
Wu, Y | 1 |
Li, B | 1 |
Mu, X | 1 |
Li, L | 1 |
Kaufman-Janette, J | 1 |
Joseph, JH | 1 |
Dayan, SH | 1 |
Smith, S | 1 |
Eaton, L | 1 |
Maffert, P | 1 |
Jones, DH | 1 |
Hessler, J | 1 |
Jonas, B | 1 |
Crider, J | 1 |
Chopra, R | 1 |
Borges, J | 1 |
Loureiro, F | 1 |
Choi, SY | 1 |
Han, HS | 1 |
Yoo, KH | 1 |
Lee, JS | 1 |
Kim, BJ | 3 |
Lee, YW | 1 |
Barbarino, SC | 1 |
Kopera, D | 1 |
Ivezic-Schoenfeld, Z | 1 |
Chang-Rodriguez, S | 1 |
Hoeller, S | 1 |
Grablowitz, D | 1 |
Bartsch, K | 1 |
Prinz, M | 1 |
Huang, SH | 1 |
Tsai, TF | 1 |
Baumann, K | 1 |
Alm, J | 1 |
Norberg, M | 1 |
Ejehorn, M | 1 |
Boen, M | 1 |
Alhaddad, M | 1 |
Goldman, MP | 2 |
Kollipara, R | 1 |
Hoss, E | 1 |
Wu, DC | 1 |
Shome, D | 1 |
Shah, RA | 1 |
Gowda, D | 1 |
Vadera, S | 1 |
Kumar, V | 1 |
Raj, M | 1 |
Atif, A | 1 |
Doshi, K | 1 |
Vekaria, M | 1 |
Pathak, M | 1 |
Kapoor, R | 1 |
Caprari, E | 1 |
Viciguerra, MT | 1 |
Milani, M | 1 |
Weinkle, S | 1 |
Cho, Y | 1 |
LaTowsky, B | 1 |
Prather, H | 1 |
Juhász, MLW | 1 |
Levin, MK | 1 |
Marmur, ES | 1 |
Lapatina, NG | 1 |
Pavlenko, T | 1 |
Fagien, S | 1 |
Monheit, G | 1 |
Sadick, N | 1 |
Nogueira, A | 3 |
Mashburn, JH | 2 |
Brown, L | 1 |
Taylor, D | 1 |
Weiss, E | 1 |
Weiss, RA | 2 |
Grekin, S | 1 |
Narins, R | 1 |
Gold, M | 1 |
Donofrio, L | 1 |
Shawcross, H | 1 |
Brown, S | 1 |
Palm, MD | 1 |
Misell, LM | 1 |
Li, CN | 1 |
Wang, CC | 1 |
Huang, CC | 1 |
Wang, HH | 1 |
Hsu, NJ | 1 |
Micheels, P | 3 |
Eng, MO | 1 |
Besse, S | 1 |
Sarazin, D | 1 |
Obamba, M | 1 |
Muti, GF | 1 |
Ogilvie, P | 1 |
Gaymans, F | 1 |
Belhaouari, L | 1 |
Weichman, BM | 1 |
Snow, S | 1 |
Chawla, S | 1 |
Abrams, S | 1 |
Schumacher, A | 1 |
Royo de la Torre, J | 1 |
Moreno-Moraga, J | 1 |
Isarría, MJ | 1 |
Muñoz, E | 1 |
Cruz, I | 1 |
Pérez, G | 1 |
Cornejo, P | 1 |
Dixit, S | 1 |
Lowe, P | 1 |
Fischer, G | 1 |
Lim, A | 1 |
Oni, G | 1 |
Rasko, Y | 1 |
Kenkel, J | 1 |
Fabi, SG | 1 |
Champagne, JP | 1 |
Nettar, KD | 1 |
Maas, CS | 1 |
Kim, A | 1 |
Jung, J | 1 |
Pak, A | 1 |
Gilbert, E | 1 |
Calvisi, L | 1 |
Beer, KR | 1 |
Hitchcock, TM | 1 |
Dobke, MK | 1 |
Nagar, R | 1 |
Glogau, RG | 1 |
Dover, JS | 1 |
Shamban, A | 1 |
Handiwala, L | 1 |
Olin, JT | 1 |
Bulley, B | 1 |
Flynn, TC | 1 |
Thompson, DH | 1 |
Hyun, SH | 1 |
Howell, DJ | 2 |
Wirtzer, A | 1 |
Shirazi, A | 1 |
Moradi-Poehler, J | 1 |
Turner, J | 1 |
Choi, WJ | 1 |
Han, SW | 1 |
Kim, JE | 2 |
Kim, HW | 1 |
Kim, MB | 1 |
Kang, H | 2 |
Joo, HJ | 1 |
Woo, YJ | 1 |
Few, J | 1 |
Dover, J | 1 |
Lin, X | 1 |
Mashburn, J | 1 |
Shi, XH | 1 |
Zhou, X | 1 |
Zhang, YM | 1 |
Lei, ZY | 1 |
Liu, T | 1 |
Fan, DL | 1 |
Pavlidis, L | 1 |
Spyropoulou, GA | 1 |
Terzidou, M | 1 |
Demiri, E | 1 |
Schachter, D | 1 |
Bertucci, V | 1 |
Solish, N | 1 |
Lee, JH | 2 |
Kim, SH | 1 |
Park, ES | 1 |
Suh, JH | 1 |
Oh, CT | 1 |
Im, SI | 1 |
Lim, JS | 1 |
Imhof, M | 1 |
Kühne, U | 1 |
Wahl, G | 1 |
Levy, PM | 2 |
De Boulle, K | 2 |
Raspaldo, H | 2 |
Weinkle, SH | 1 |
Bank, DE | 2 |
Boyd, CM | 1 |
Gold, MH | 1 |
Thomas, JA | 1 |
Murphy, DK | 1 |
Monheit, GD | 1 |
Campbell, RM | 1 |
Neugent, H | 1 |
Nelson, CP | 1 |
Prather, CL | 1 |
Bachtell, N | 1 |
Eng, D | 1 |
Holmdahl, L | 1 |
Martin, DB | 1 |
Mandy, SH | 1 |
Carruthers, JA | 1 |
Carruthers, JD | 1 |
Poirier, J | 1 |
Oliff, HS | 1 |
Mordaunt, J | 1 |
Schreiber, WE | 1 |
Cattin, TA | 1 |
Busso, M | 1 |
Brandt, F | 1 |
Cross, SL | 1 |
Weiss, R | 1 |
Mole, B | 1 |
Gozlan, L | 1 |
Iannitti, T | 1 |
Capone, S | 1 |
Palmieri, B | 1 |
Stephan, F | 1 |
Maatouk, I | 1 |
Moutran, R | 1 |
Obeid, G | 1 |
Segura, S | 1 |
Anthonioz, L | 1 |
Fuchez, F | 1 |
Herbage, B | 1 |
Wilder-Smith, E | 1 |
Chow, A | 1 |
Kilmer, SL | 2 |
Chotzen, V | 1 |
Zelickson, BD | 1 |
McClaren, M | 1 |
Silva, S | 1 |
Calkin, J | 1 |
No, D | 1 |
Touma, D | 1 |
Yaar, M | 1 |
Whitehead, S | 1 |
Konnikov, N | 1 |
Gilchrest, BA | 1 |
Rullan, PP | 1 |
Chotzen, VA | 1 |
Silva, SK | 1 |
McClaren, ML | 1 |
Kashkouli, MB | 1 |
Salimi, S | 1 |
Bakhtiari, P | 1 |
Parvaresh, MM | 1 |
Sanjari, MS | 1 |
Naseripour, M | 1 |
Goodman, G | 1 |
Khatri, KA | 1 |
Machado, A | 1 |
Magro, C | 1 |
Davenport, S | 1 |
Lauber, JS | 1 |
Abrams, HL | 1 |
Coleman, WP | 1 |
Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
---|---|---|---|---|---|---|---|
Evaluation of Effectiveness and Safety of Radiesse (+) to Improve the Contour of Jawline by Adding Volume to the Jawline[NCT03583359] | 180 participants (Actual) | Interventional | 2018-08-06 | Completed | |||
Open-label, Multicenter, Uncontrolled, Rater-blinded, Post-market Clinical Follow-up [PMCF] Study to Confirm Performance and Safety of RADIESSE® (+) Lidocaine in the Treatment of Nasolabial Folds, Marionette Lines, and/or Cheek Volume Loss[NCT03650387] | 207 participants (Actual) | Interventional | 2018-09-17 | Completed | |||
A Randomized, Multi-center, Evaluator-blinded, No-treatment Controlled Study to Evaluate the Efficacy and Safety of Restylane Perlane Lidocaine for Correction of Midface Volume Deficit and/or Midface Contour Deficiency[NCT03097783] | 169 participants (Actual) | Interventional | 2017-04-26 | Completed | |||
A Randomized, Controlled, Double-blinded, Within-subject (Split-face), Multicenter, Prospective Clinical Study to Compare the Level of Pain Using the Dermal Filler RHA® Redensity Formulated With Two Different Anesthetics in the Treatment of Perioral Rhyti[NCT04069585] | 30 participants (Actual) | Interventional | 2019-10-30 | Completed | |||
A Multicenter, Open-Label, Prospective Study of Cannula Injection of Restylane Lyft With Lidocaine for Cheek Augmentation and the Correction of Age Related Midface Contour Deficiencies[NCT03160716] | 60 participants (Actual) | Interventional | 2017-05-16 | Completed | |||
Effects of Calcium Hydroxylapatite on Cellulite Dimples in the Buttocks[NCT05885035] | Phase 1 | 25 participants (Actual) | Interventional | 2023-01-01 | Completed | ||
Treatment Prior to Injection and Biopsy of the Vulva[NCT03444727] | 13 participants (Actual) | Interventional | 2018-02-19 | Terminated (stopped due to Not enough enrollment) | |||
Fractional Carbon Dioxide Laser Assisted Delivery of Topical Anesthetics: a Randomized Controlled Pilot Study[NCT02246179] | Phase 4 | 10 participants (Actual) | Interventional | 2014-09-30 | Completed | ||
Parameters in Fractional Laser Assisted Delivery of Topical Anesthetics: Role of Anesthetic and Application Time[NCT03279757] | Phase 4 | 15 participants (Actual) | Interventional | 2016-10-01 | Completed | ||
Parameters in Fractional Laser Assisted Delivery of Topical Anesthetics: Role of Laser Type and Laser Settings[NCT02938286] | Phase 4 | 15 participants (Actual) | Interventional | 2016-03-31 | Completed | ||
Fractional CO2 Laser Assisted Topical Articaine Anesthesia vs. Topical EMLA Administration: a Randomized Controlled Study[NCT02548533] | Phase 4 | 3 participants (Actual) | Interventional | 2015-06-30 | Terminated (stopped due to Not enough patients eligible for recruitment.) | ||
A Study Evaluating Blended Belotero for the Treatment of Etched-in Fine Facial Lines[NCT02626598] | 30 participants (Anticipated) | Observational [Patient Registry] | 2015-12-31 | Enrolling by invitation | |||
Evaluation of Pain With the Use of Radiesse® With Lidocaine for the Treatment of Nasolabial Folds[NCT01069354] | 102 participants (Actual) | Interventional | 2012-11-30 | Completed | |||
Efficacy of Injected Local Anesthetic vs Topical Anesthetic in Cosmetic Injectable Fillers[NCT02379221] | 49 participants (Actual) | Interventional | 2014-09-30 | Completed | |||
[NCT00653861] | 72 participants (Actual) | Interventional | 2008-04-30 | Completed | |||
[information is prepared from clinicaltrials.gov, extracted Sep-2024] |
The participant assessed satisfaction using the Face-Q Satisfaction with Lower Face and Jawline module (Rasch transformed score 0-100; higher scores mean better outcome). (NCT03583359)
Timeframe: Baseline up to Week 12
Intervention | percent change (Mean) |
---|---|
Treatment With Radiesse (+) | 269.8 |
Control/Delayed Treatment With Radiesse (+) | -9.4 |
MJAS was a 5-point scale (0-4 scores; higher scores mean worse outcome). Responder rate was defined as percentage of participants with a greater than or equal to (>=) 1-point improvement. (NCT03583359)
Timeframe: At Week 12
Intervention | percentage of participants (Number) |
---|---|
Treatment With Radiesse (+) | 75.6 |
Control/Delayed Treatment With Radiesse (+) | 8.8 |
MJAS was a 5-point scale (0-4 scores; higher scores mean worse outcome). Responder rate was defined as percentage of participants with a >=1-point improvement. (NCT03583359)
Timeframe: At Week 12
Intervention | percentage of participants (Number) |
---|---|
Treatment With Radiesse (+) | 47.7 |
Control/Delayed Treatment With Radiesse (+) | 8.2 |
(NCT03583359)
Timeframe: Baseline up to end of study (Week 60)
Intervention | Participants (Count of Participants) | |
---|---|---|
Participants with Device and/or Injection Related TEAEs | Participants with Device and/or Injection Related Serious TEAEs | |
Control/Delayed Treatment With Radiesse (+) | 10 | 0 |
Treatment With Radiesse (+) | 36 | 0 |
(NCT03650387)
Timeframe: Baseline up to Week 72 (for participants with no touch-up) or Week 76 (for participants with touch-up)
Intervention | Participants (Count of Participants) |
---|---|
RADIESSE® (+) Lidocaine: Nasolabial Folds | 139 |
RADIESSE® (+) Lidocaine: Marionette Lines | 133 |
RADIESSE® (+) Lidocaine: Cheek Volume Loss | 129 |
RADIESSE® (+) Lidocaine: All Participants | 142 |
The MUCFS was used to assess the severity of volume loss of upper cheeks. The assessment was performed separately for the left and the right cheek by the blinded rater and the treating investigator (at baseline only prior to SMD injection) by live rating. MUCFS was a 5 point scale ranging as: 0 (full upper cheek), 1 (mildly sunken upper cheek), 2 (moderately sunken upper cheek), 3 (severely sunken upper cheek), 4 (very severely sunken upper cheek). Responders rate was defined as percentage of participants who achieved improvement of >=1 point in both cheeks (left and right) from Day 1 pre-injection to Week 12/16 (depending on touch-up). As planned, the cumulative data was collected for Week 12 or Week 16 based on the touch-up. (NCT03650387)
Timeframe: At Week 12 (for participants with no touch-up) or Week 16 (for participants with touch-up)
Intervention | percentage of participants (Number) |
---|---|
RADIESSE® (+) Lidocaine: Cheek Volume Loss | 81.9 |
The MMLS was used to assess the severity of marionette lines. The assessment was performed separately for the left and the right marionette line by the blinded rater and the treating investigator (at baseline only prior to SMD injection) by live rating. MMLS was a 5 point scale ranging as: 0 (no lines), 1 (mild lines), 2 (moderate lines), 3 (severe lines), 4 (very severe lines). Responders rate was defined as percentage of participants who achieved improvement of >=1 point in both marionette lines (left and right) from Day 1 pre-injection to Week 12/16 (depending on touch-up). As planned, the cumulative data was collected for Week 12 or Week 16 based on the touch-up. (NCT03650387)
Timeframe: At Week 12 (for participants with no touch-up) or Week 16 (for participants with touch-up)
Intervention | percentage of participants (Number) |
---|---|
RADIESSE® (+) Lidocaine: Marionette Lines | 88.7 |
The MNLFS was used to assess the severity of nasolabial folds. The assessment was performed separately for the left and the right nasolabial fold by the blinded rater and the treating investigator (at baseline only prior to SMD injection) by live rating. MNLFS was a 5 point scale ranging as: 0 (no folds), 1 (mild folds), 2 (moderate folds), 3 (severe folds), 4 (very severe folds). Responders rate was defined as percentage of participants who achieved improvement of greater than or equal to (>=) 1 point in both folds (left and right) from Day 1 pre-injection to Week 12/16 (depending on touch-up). As planned, the cumulative data was collected for Week 12 or Week 16 based on the touch-up. (NCT03650387)
Timeframe: At Week 12 (for participants with no touch-up) or Week 16 (for participants with touch-up)
Intervention | percentage of participants (Number) |
---|---|
RADIESSE® (+) Lidocaine: Nasolabial Folds | 93.6 |
The MUCFS was used to assess the severity of volume loss of upper cheeks. The assessment was performed separately for the left and the right cheek by the blinded rater and the treating investigator (at baseline only prior to SMD injection) by live rating. MUCFS was based on 5 point scale ranging from: 0 (full upper cheek), 1 (mildly sunken upper cheek), 2 (moderately sunken upper cheek), 3 (severely sunken upper cheek), 4 (very severely sunken upper cheek). Responders rate was defined as percentage of participants who achieved improvement of >=1 point in both cheeks (left and right) from Day 1 pre-injection to Week 4, Week 24/28, Week 48/52, and Week 72/76 (depending on touch-up). As planned, the cumulative data was collected for Week 24 or 28, Week 48 or 52, and Week 72 or 76 based on the touch-up. (NCT03650387)
Timeframe: At Week 4 (prior to optional touch-up); at Weeks 24, 48 and 72 (for participants with no touch-up) or at Weeks 28, 52 and 76 (for participants with touch-up)
Intervention | percentage of participants (Number) | |||
---|---|---|---|---|
Week 4 | Week 24/28 (Depending Upon Touch-up) | Week 48/52 (Depending Upon Touch-up) | Week 72/76 (Depending Upon Touch-up) | |
RADIESSE® (+) Lidocaine: Cheek Volume Loss | 84.6 | 72.9 | 51.6 | 30.9 |
The MMLS was to be used to assess the severity of marionette lines. The assessment was performed separately for the left and the right marionette line by the blinded rater and the treating investigator (at baseline only prior to SMD injection) by live rating. MMLS was a 5 point scale ranging from: 0 (no lines), 1 (mild lines), 2 (moderate lines), 3 (severe lines), 4 (very severe lines). Responders rate was defined as percentage of participants who achieved improvement of >=1 point in both marionette lines (left and right) from Day 1 pre-injection to Week 4, Week 24/28, Week 48/52, and Week 72/76 (depending on touch-up). As planned, the cumulative data was collected for Week 24 or 28, Week 48 or 52, and Week 72 or 76 based on the touch-up. (NCT03650387)
Timeframe: At Week 4 (prior to optional touch-up); and at Weeks 24, 48 and 72 (for participants with no touch-up) or at Weeks 28, 52 and 76 (for participants with touch-up)
Intervention | percentage of participants (Number) | |||
---|---|---|---|---|
Week 4 | Week 24/28 (Depending Upon Touch-up) | Week 48/52 (Depending Upon Touch-up) | Week 72/76 (Depending Upon Touch-up) | |
RADIESSE® (+) Lidocaine: Marionette Lines | 86.6 | 71.6 | 35.6 | 16.0 |
The MNLFS was used to assess the severity of nasolabial folds. The assessment was performed separately for the left and the right nasolabial fold by the blinded rater and the treating investigator (at baseline only prior to SMD injection) by live rating. MNLFS was a 5 point scale ranging as: 0 (no folds), 1 (mild folds), 2 (moderate folds), 3 (severe folds), 4 (very severe folds). Responders rate was defined as percentage of participants who achieved improvement of >=1 point in both folds (left and right) from Day 1 pre-injection to Week 4, Week 24/28, Week 48/52, and Week 72/76 (depending on touch-up). As planned, the cumulative data was collected for Week 24 or 28, Week 48 or 52, and Week 72 or 76 based on the touch-up. (NCT03650387)
Timeframe: At Week 4 (prior to optional touch-up); at Weeks 24, 48 and 72 (for participants with no touch-up) or at Weeks 28, 52 and 76 (for participants with touch-up)
Intervention | percentage of participants (Number) | |||
---|---|---|---|---|
Week 4 | Week 24/28 (Depending Upon Touch-up) | Week 48/52 (Depending Upon Touch-up) | Week 72/76 (Depending Upon Touch-up) | |
RADIESSE® (+) Lidocaine: Nasolabial Folds | 87.6 | 78.2 | 41.6 | 23.3 |
The Subject's Global Aesthetic Improvement Scale (sGAIS) was used to assess aesthetic improvement in the participants by the participant by live rating using baseline photographs for comparison. The participant was asked: 'What is your overall impression of change of your aesthetic result due to treatment, compared to the condition before the injection? Please tick the one option that best fits your overall impression of change based on your comparison of the baseline visit photographs.' Rating based on 7 point rating scale ranging from: +3 (very much improved), +2 (much improved), +1 (improved), 0 (no change), -1 (worse), -2 (much worse), -3 (very much worse). As planned, the cumulative data was collected at Week 4 (prior to optional touch-up), Week 12 or 16, Week 24 or 28, Week 48 or 52, and Week 72 or 76 based on the touch-up. (NCT03650387)
Timeframe: At Week 4 (prior to optional touch-up); at Weeks 12, 24, 48 and 72 (for participants with no touch-up) or at Weeks 16, 28, 52 and 76 (for participants with touch-up)
Intervention | Participants (Count of Participants) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Week 472383292 | Week 472383295 | Week 472383293 | Week 472383294 | Week 12/16 (Depending Upon Touch-up)72383293 | Week 12/16 (Depending Upon Touch-up)72383292 | Week 12/16 (Depending Upon Touch-up)72383295 | Week 12/16 (Depending Upon Touch-up)72383294 | Week 24/28 (Depending Upon Touch-up)72383295 | Week 24/28 (Depending Upon Touch-up)72383292 | Week 24/28 (Depending Upon Touch-up)72383293 | Week 24/28 (Depending Upon Touch-up)72383294 | Week 48/52 (Depending Upon Touch-up)72383292 | Week 48/52 (Depending Upon Touch-up)72383295 | Week 48/52 (Depending Upon Touch-up)72383293 | Week 48/52 (Depending Upon Touch-up)72383294 | Week 72/76 (Depending Upon Touch-up)72383292 | Week 72/76 (Depending Upon Touch-up)72383295 | Week 72/76 (Depending Upon Touch-up)72383293 | Week 72/76 (Depending Upon Touch-up)72383294 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Much Improved | Very Much Improved | Improved | No Change | Worse | Much Worse | Very Much Worse | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Nasolabial Folds | 9 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Marionette Lines | 7 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Cheek Volume Loss | 9 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: All Participants | 9 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Nasolabial Folds | 71 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Marionette Lines | 70 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Cheek Volume Loss | 71 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: All Participants | 75 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Nasolabial Folds | 102 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Marionette Lines | 98 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Cheek Volume Loss | 89 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: All Participants | 102 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Nasolabial Folds | 18 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Marionette Lines | 17 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Cheek Volume Loss | 17 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: All Participants | 18 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Marionette Lines | 19 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: All Participants | 20 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Nasolabial Folds | 84 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Marionette Lines | 80 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Cheek Volume Loss | 80 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: All Participants | 87 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Nasolabial Folds | 80 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Marionette Lines | 78 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Cheek Volume Loss | 73 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: All Participants | 81 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Marionette Lines | 10 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Cheek Volume Loss | 8 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Nasolabial Folds | 8 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Marionette Lines | 8 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Cheek Volume Loss | 7 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: All Participants | 8 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Marionette Lines | 59 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Nasolabial Folds | 90 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Marionette Lines | 87 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Cheek Volume Loss | 86 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: All Participants | 92 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Nasolabial Folds | 27 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Marionette Lines | 26 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Cheek Volume Loss | 22 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: All Participants | 27 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Nasolabial Folds | 5 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Marionette Lines | 4 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Cheek Volume Loss | 5 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: All Participants | 5 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Marionette Lines | 1 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Marionette Lines | 0 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Nasolabial Folds | 26 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Marionette Lines | 24 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Cheek Volume Loss | 23 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: All Participants | 26 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Nasolabial Folds | 87 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Marionette Lines | 84 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Cheek Volume Loss | 82 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: All Participants | 89 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Nasolabial Folds | 47 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Marionette Lines | 46 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Cheek Volume Loss | 43 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: All Participants | 49 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Nasolabial Folds | 16 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Marionette Lines | 16 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Cheek Volume Loss | 15 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: All Participants | 16 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Marionette Lines | 2 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Nasolabial Folds | 1 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Cheek Volume Loss | 1 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: All Participants | 1 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Nasolabial Folds | 20 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Marionette Lines | 21 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Cheek Volume Loss | 20 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: All Participants | 21 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Nasolabial Folds | 63 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Marionette Lines | 60 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Cheek Volume Loss | 57 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Nasolabial Folds | 61 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Marionette Lines | 57 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Cheek Volume Loss | 56 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: All Participants | 63 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Nasolabial Folds | 11 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Marionette Lines | 11 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Cheek Volume Loss | 11 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: All Participants | 11 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Nasolabial Folds | 2 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Cheek Volume Loss | 2 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: All Participants | 2 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Nasolabial Folds | 0 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Cheek Volume Loss | 0 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: All Participants | 0 |
The Investigator's Global Aesthetic Improvement Scale (iGAIS) was used to assess aesthetic improvement in the participants by the treating investigator by live rating using baseline photographs for comparison. The treating investigator was asked: 'Based on your clinical experience, what is your overall impression of change of the participant's aesthetic result due to treatment, compared to the condition before the first treatment (baseline)? Please check the one option that best fits your overall impression of change based on your comparison of the baseline visit photographs.' Rating was based on 7 point rating scale ranging from: +3 (very much improved), +2 (much improved), +1 (improved), 0 (no change), -1 (worse), -2 (much worse), -3 (very much worse). As planned, the cumulative data was collected at Week 4 (prior to optional touch-up), Week 12 or 16, Week 24 or 28, Week 48 or 52, and Week 72 or 76 based on the touch-up. (NCT03650387)
Timeframe: At Week 4 (prior to optional touch-up); at Weeks 12, 24, 48 and 72 (for participants with no touch-up) or at Weeks 16, 28, 52 and 76 (for participants with touch-up)
Intervention | Participants (Count of Participants) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Week 472383289 | Week 472383294 | Week 472383292 | Week 472383293 | Week 12/16 (Depending Upon Touch-up)72383289 | Week 12/16 (Depending Upon Touch-up)72383292 | Week 12/16 (Depending Upon Touch-up)72383293 | Week 12/16 (Depending Upon Touch-up)72383294 | Week 24/28 (Depending Upon Touch-up)72383289 | Week 24/28 (Depending Upon Touch-up)72383293 | Week 24/28 (Depending Upon Touch-up)72383294 | Week 24/28 (Depending Upon Touch-up)72383292 | Week 48/52 (Depending Upon Touch-up)72383292 | Week 48/52 (Depending Upon Touch-up)72383293 | Week 48/52 (Depending Upon Touch-up)72383289 | Week 48/52 (Depending Upon Touch-up)72383294 | Week 72/76 (Depending Upon Touch-up)72383289 | Week 72/76 (Depending Upon Touch-up)72383292 | Week 72/76 (Depending Upon Touch-up)72383293 | Week 72/76 (Depending Upon Touch-up)72383294 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Improved | No Change | Worse | Much Worse | Very Much Worse | Very Much Improved | Much Improved | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Marionette Lines | 23 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Cheek Volume Loss | 24 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: All Participants | 26 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Marionette Lines | 102 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Cheek Volume Loss | 100 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: All Participants | 107 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Nasolabial Folds | 67 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Marionette Lines | 65 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Cheek Volume Loss | 60 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: All Participants | 68 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Nasolabial Folds | 4 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Marionette Lines | 3 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Cheek Volume Loss | 3 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: All Participants | 4 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Nasolabial Folds | 32 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Marionette Lines | 30 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Cheek Volume Loss | 30 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: All Participants | 32 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Nasolabial Folds | 115 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Marionette Lines | 113 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Cheek Volume Loss | 108 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: All Participants | 118 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Nasolabial Folds | 43 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Marionette Lines | 39 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Cheek Volume Loss | 40 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: All Participants | 44 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Nasolabial Folds | 7 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Marionette Lines | 7 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Cheek Volume Loss | 5 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: All Participants | 7 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Nasolabial Folds | 0 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Marionette Lines | 0 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Cheek Volume Loss | 0 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Nasolabial Folds | 6 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Marionette Lines | 4 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Cheek Volume Loss | 6 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Nasolabial Folds | 86 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Marionette Lines | 87 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Cheek Volume Loss | 85 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: All Participants | 89 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Nasolabial Folds | 76 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Marionette Lines | 70 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Cheek Volume Loss | 68 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: All Participants | 77 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Nasolabial Folds | 24 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Marionette Lines | 24 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Cheek Volume Loss | 19 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: All Participants | 24 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Nasolabial Folds | 1 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Cheek Volume Loss | 1 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Nasolabial Folds | 13 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Marionette Lines | 12 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Cheek Volume Loss | 13 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: All Participants | 13 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Nasolabial Folds | 106 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Marionette Lines | 105 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: All Participants | 109 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Nasolabial Folds | 58 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Marionette Lines | 55 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Cheek Volume Loss | 51 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: All Participants | 59 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Marionette Lines | 1 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: All Participants | 1 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: All Participants | 0 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Marionette Lines | 6 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: All Participants | 6 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Nasolabial Folds | 64 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Marionette Lines | 62 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Cheek Volume Loss | 61 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: All Participants | 65 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Nasolabial Folds | 88 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Marionette Lines | 84 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: Cheek Volume Loss | 80 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
RADIESSE® (+) Lidocaine: All Participants | 90 |
"The primary objective is to demonstrate superiority of Perlane-Lido relative to no-treatment in the treatment of Midface volume Deficit and/or Midface Contour Deficiency by comparing the percent responders, defined by at least 1 point improvement from baseline on the MMVS on both sides of the face, as measured by blinded evaluator at 6 months.~Medicis Midface Volume Scale (MMVS) is a 4-grade scale assesses the fullness of the midface from Fairly Full (1) to Substantial Loss of Fullness (4) as described below. The blinded evaluator and treating investigator will rate the subject's right and left midface for severity of volume deficiency using the MMVS at all applicable study visits.~Fairly full midface~Mild loss of fullness in midface area~Moderate loss of fullness with slight hollowing below malar prominence~Substantial loss of fullness in the midface area, clearly apparent hollowing below malar prominence" (NCT03097783)
Timeframe: 6 month
Intervention | Participants (Count of Participants) |
---|---|
Restylane Perlane Lidocaine | 67 |
No Intervention Arm | 8 |
"Injection pain during injection was measured on the 100 mm Visual Analog Scale (VAS), as assessed by subjects immediately after injection of each upper perioral quadrant.~VAS is a 100 mm Visual Analog Scale with 0 meaning no pain and 100 meaning intolerable pain" (NCT04069585)
Timeframe: Visit 1 - During Injection
Intervention | mm (Mean) |
---|---|
RHA® Redensity With Lidocaine | 22.4 |
RHA® Redensity With New Anesthetic Agent | 25.0 |
"Global Aesthetic Improvement (GAI) is a subjective 5-grade scale comprised of much improved, improved, no change, worse, and much worse.~GAI was assessed using the baseline photograph. Subjects were instructed as follows: Use a mirror to compare your face to the photograph provided to you and rate the degree of aesthetic improvement by using the following scale.~Each side of the face was assessed independently." (NCT04069585)
Timeframe: Visit 1 (post-injection) and Visit 2 (Day 30)
Intervention | Participants (Count of Participants) | |
---|---|---|
Visit 1 (post-injection) | Visit 2 (Day 30) | |
RHA® Redensity With Lidocaine | 30 | 30 |
RHA® Redensity With New Anesthetic Agent | 30 | 30 |
"Global Aesthetic Improvement (GAI) is a subjective 5-grade scale comprised of much improved, improved, no change, worse, and much worse.~GAI will bewas assessed using the baseline photograph. Each side of the mouth were assessed independently." (NCT04069585)
Timeframe: Visit 1 (post-injection) and Visit 2 (Day 30)
Intervention | Participants (Count of Participants) | |
---|---|---|
Visit 1 (post-injection) | Visit 2 (Day30) | |
RHA® Redensity With Lidocaine | 30 | 30 |
RHA® Redensity With New Anesthetic Agent | 30 | 30 |
"PR-SRS (Perioral Rhytids Severity Rating Scale) is a validated 4-grade scale with 0 being Absent and 3 being Severe" (NCT04069585)
Timeframe: Visit 1 (Baseline, pre-injection) - Visit 1 (post-injection), Visit 2 (Day 30)
Intervention | units on a scale (Mean) | |
---|---|---|
Visit 1 (Post-injection) | Visit 2 (Day 30) | |
RHA® Redensity With Lidocaine | -1.5 | -1.4 |
RHA® Redensity With New Anesthetic Agent | -1.5 | -1.4 |
"Injection pain was measured on the 100 mm Visual Analog Scale (VAS), as assessed by subjects in each side of the mouth.~VAS is a 100 mm Visual Analog Scale with 0 meaning no pain and 100 meaning intolerable pain" (NCT04069585)
Timeframe: Visit 1 - 15, 30, 45 and 60 minutes post-injection
Intervention | mm (Mean) | |||
---|---|---|---|---|
15 Min | 30 Min | 45 Min | 60 Min | |
RHA® Redensity With Lidocaine | 6.3 | 1.0 | 0.3 | 0.0 |
RHA® Redensity With New Anesthetic Agent | 6.8 | 1.0 | 0.4 | 0.0 |
"The subjects will receive a diary booklet and instructions for recording his/her observations of the Common Treatment Responses to the study treatments within 30 days following the treatment. The diary will be discussed during follow-up phone-call and visit. Subjects were instructed to complete the diary at approximately the same time each day (i.e., am or pm).~The subject diary captured the following Common Treatment Responses (CTR) that occur following the injection of a dermal filler; specifically, redness, pain, tenderness, firmness, swelling, lumps/bumps, bruising, itching, discoloration, and other.~The 30-day patient CTR diary included a detailed glossary describing all signs/symptoms listed in the diary; an option was provided to report other reactions if the subject experienced a sign/symptom that was not listed." (NCT04069585)
Timeframe: During 30 days after injection
Intervention | Participants (Count of Participants) | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Bruising | Discoloration | Firmness | Itching | Lumps/Bumps | Pain | Redness | Swelling | Tenderness | Needle track marks | Injection Site Soreness | |
RHA® Redensity With Lidocaine | 16 | 10 | 19 | 2 | 17 | 4 | 15 | 19 | 12 | 1 | 1 |
RHA® Redensity With New Anesthetic Agent | 12 | 10 | 14 | 4 | 15 | 3 | 16 | 21 | 13 | 1 | 1 |
"The FACE-Q measures the experience and outcomes of aesthetic facial procedures from the patient's perspective.~FACE-Q questionnaire is composed of 6 questions with a score linked to answers (1 being 'Not at all' and 4 being 'Extremely').~The subject will be instructed as follows: These questions ask about how you look right now. For each question, circle only one answer. With the area around your lips in mind, in the past week, how much have you been bothered by:, and will provide response.~To calculate the FACE-Q, outcomes from all 6 questions were pooled, data were transformed so that higher scores reflected a superior outcome, and adapted to a scale of 100 units (i.e. lowest score = 0, highest score = 100)." (NCT04069585)
Timeframe: Visit 1 (Baseline) and Visit 2 (Day 30)
Intervention | score on a scale (Mean) | ||
---|---|---|---|
Baseline Face-Q Score | Day 30 Face-Q Score | Face-Q Change from Baseline to Day 30 | |
RHA® Redensity With Lidocaine | 13.0 | 73.9 | 60.9 |
RHA® Redensity With New Anesthetic Agent | 12.5 | 77.2 | 64.7 |
"The Subject Satisfaction Scale is a subjective, balanced, 5-point scale assessing subject satisfaction with study treatment. Possible scores range from with 1 (very satisfied) to 5 (very dissatisfied).~Proportion of subjects who were Satisfied (i.e., 1-Very Satisfied + 2-Satisfied) was compared to the proportion of subjects who were Not Satisfied (i.e., 3-Neither Satisfied nor dissatisfied + 4-Dissatisfied + 5-Very Dissatisfied)" (NCT04069585)
Timeframe: Visit 1 (post-injection) and Visit 2 (Day 30)
Intervention | Participants (Count of Participants) | |||||||
---|---|---|---|---|---|---|---|---|
Visit 1 (post-injection)72557804 | Visit 1 (post-injection)72557805 | Visit 2 (Day 30)72557804 | Visit 2 (Day 30)72557805 | |||||
Satisfied (i.e., 1-Very Satisfied + 2-Satisfied) | Not Satisfied (i.e., 3-Neither Satisfied nor dissa | |||||||
RHA® Redensity With Lidocaine | 29 | |||||||
RHA® Redensity With New Anesthetic Agent | 29 | |||||||
RHA® Redensity With Lidocaine | 1 | |||||||
RHA® Redensity With New Anesthetic Agent | 1 |
A responder corresponds to a subject with an intra-individual improvement of at least one grade on the PR-SRS compared to Baseline (NCT04069585)
Timeframe: Visit 1 - Baseline (pre-injection), Visit 1 (post-injection), Visit 2 (Day 30)
Intervention | Participants (Count of Participants) | |||||||
---|---|---|---|---|---|---|---|---|
Visit 1 - post-injection72557804 | Visit 1 - post-injection72557805 | Visit 2 - day 3072557804 | Visit 2 - day 3072557805 | |||||
Responder | Not responder | |||||||
RHA® Redensity With Lidocaine | 29 | |||||||
RHA® Redensity With New Anesthetic Agent | 28 | |||||||
RHA® Redensity With Lidocaine | 1 | |||||||
RHA® Redensity With New Anesthetic Agent | 2 | |||||||
RHA® Redensity With New Anesthetic Agent | 29 | |||||||
RHA® Redensity With New Anesthetic Agent | 1 |
To assess effectiveness using the 4-point Midface Volume Scale. Responder defined as at least a one point improvement from the baseline score at 2 weeks after week 16 re-treatment (visit only required for participants who received re-treatment at week 16). (NCT03160716)
Timeframe: 16 weeks
Intervention | Participants (Count of Participants) |
---|---|
Treatment | 43 |
"To assess effectiveness using the Global Aesthetic Improvement Scale (GAIS). Responders defined as Improved or better on the GAIS as assessed by the investigator and participant at 2 weeks after week 16 re-treatment (visit only required for participants who received re-treatment at week 16)." (NCT03160716)
Timeframe: 16 weeks
Intervention | Participants (Count of Participants) |
---|---|
Treatment | 43 |
To assess the adverse events (incidence, intensity, and duration) of Restylane® Lyft with Lidocaine in conjunction with the use of a cannula. (NCT03160716)
Timeframe: 16 weeks
Intervention | Participants (Count of Participants) |
---|---|
Treatment | 5 |
To assess subject satisfaction with the treatment using the FACE-Q. Score range 1-100. The higher total score indicate greater subject satisfaction. (NCT03160716)
Timeframe: 8 weeks
Intervention | score on a scale (Mean) |
---|---|
Treatment | 77.3 |
"In this split-face study, a clinically meaningful difference in pain was defined as a 2-cm reduction (i.e., subject reports at least 2-cm less pain on a 10-cm VAS) in the Radiesse® Mixed with Lidocaine NLF when compared to the Radiesse® without Lidocaine NLF." (NCT01069354)
Timeframe: Immediately after injection (Time 0)
Intervention | participants (Number) |
---|---|
Radiesse® Mixed With Lidocaine and Radiesse® Without Lidocaine | 91 |
"Assessment of whether a statistically significant reduction in pain score in the Radiesse® Mixed with Lidocaine nasolabial fold was observed when compared to the Radiesse® without Lidocaine nasolabial fold using a 10-cm visual analog pain scale (0 = no pain, 10 = very severe pain).~In the study protocol, the assessment of achieving a statistically significant reduction in pain at time zero was selected a priori to be analyzed using a paired t-test to test the null hypothesis that the mean of the differences in VAS scores between the Treatment and Control folds is equal to zero." (NCT01069354)
Timeframe: Immediately after injection (Time 0)
Intervention | units on a scale (Mean) |
---|---|
Radiesse® Mixed With Lidocaine | 2.32 |
Radiesse® Without Lidocaine | 6.73 |
A 10-cm VAS (with 21 total circles, marked at 0.5 cm intervals) was used in which 0 = no pain and 10 = very severe pain. (NCT01069354)
Timeframe: 1 week post injection
Intervention | units on a scale (Mean) |
---|---|
Radiesse® Mixed With Lidocaine | 0.05 |
Radiesse® Without Lidocaine | 0.04 |
A 10-cm VAS (with 21 total circles, marked at 0.5 cm intervals) was used in which 0 = no pain and 10 = very severe pain. (NCT01069354)
Timeframe: 15 minutes post injection
Intervention | units on a scale (Mean) |
---|---|
Radiesse® Mixed With Lidocaine | 1.06 |
Radiesse® Without Lidocaine | 3.45 |
A 10-cm VAS (with 21 total circles, marked at 0.5 cm intervals) was used in which 0 = no pain and 10 = very severe pain. (NCT01069354)
Timeframe: 2 weeks post injection
Intervention | units on a scale (Mean) |
---|---|
Radiesse® Mixed With Lidocaine | 0.01 |
Radiesse® Without Lidocaine | 0 |
A 10-cm VAS (with 21 total circles, marked at 0.5 cm intervals) was used in which 0 = no pain and 10 = very severe pain. (NCT01069354)
Timeframe: 30 minutes post injection
Intervention | units on a scale (Mean) |
---|---|
Radiesse® Mixed With Lidocaine | 0.73 |
Radiesse® Without Lidocaine | 2.52 |
A 10-cm VAS (with 21 total circles, marked at 0.5 cm intervals) was used in which 0 = no pain and 10 = very severe pain. (NCT01069354)
Timeframe: 4 weeks post injection
Intervention | units on a scale (Mean) |
---|---|
Radiesse® Mixed With Lidocaine | 0 |
Radiesse® Without Lidocaine | 0 |
A 10-cm VAS (with 21 total circles, marked at 0.5 cm intervals) was used in which 0 = no pain and 10 = very severe pain. (NCT01069354)
Timeframe: 45 minutes post injection
Intervention | units on a scale (Mean) |
---|---|
Radiesse® Mixed With Lidocaine | 0.48 |
Radiesse® Without Lidocaine | 1.78 |
A 10-cm VAS (with 21 total circles, marked at 0.5 cm intervals) was used in which 0 = no pain and 10 = very severe pain. (NCT01069354)
Timeframe: 60 minutes post injection
Intervention | units on a scale (Mean) |
---|---|
Radiesse® Mixed With Lidocaine | 0.31 |
Radiesse® Without Lidocaine | 1.09 |
"2 questions were asked of 101 subjects: 1) Was one treatment less painful than the other? and 2) Was the difference in pain levels significant enough to affect your preference for one treatment over the other?~Only those participants responding yes to these 2 questions about pain and preference for treatment are reported in the table below." (NCT01069354)
Timeframe: Immediately after injection (Time 0)
Intervention | "participants responding yes" (Number) | |
---|---|---|
Was One Treatment Less Painful Than the Other? | Pain Significant Enough to Affect Preference? | |
Radiesse® Mixed With Lidocaine and Radiesse® Without Lidocaine | 98 | 87 |
Participant will complete a questionnaire to evaluate his/her pain level perception using a Visual Analog Scale (VAS) during injection of HA filler to the upper lip. The Visual Analog scale uses a 10 cm horizontal line with 'no pain' labeled on the left end of line and 'worst pain' on the right end of line. Participant marks their pain level at any point on the line from no pain to worst pain. No pain= 0 cm, Worst pain=10cm (NCT02379221)
Timeframe: 5-10 minutes post procedure
Intervention | units on a scale (Mean) |
---|---|
Injectable | 0.89 |
Topical | 3.67 |
A mean level of pain for all participants completing the Visual Analog Scale (VAS) during injection of HA filler to the lower lip. The Visual Analog scale uses a 10 cm horizontal line with 'no pain' labeled on the left end of line and 'worst pain' on the right end of line. Participant marks their pain level at any point on the line from no pain to worst pain. No pain= 0 cm, Worst pain=10cm. The total score was divided by 48. (NCT02379221)
Timeframe: 5-10 minutes post procedure
Intervention | units on a scale (Mean) |
---|---|
Injectable | 1.47 |
Topical | 4.38 |
Participant will complete a questionnaire to evaluate his/her pain level perception using a Visual Analog Scale (VAS) during injection of HA filler to the nasolabial fold. The Visual Analog scale uses a 10 cm horizontal line with 'no pain' labeled on the left end of line and 'worst pain' on the right end of line. Participant marks their pain level at any point on the line from no pain to worst pain. No pain= 0 cm, Worst pain=10cm (NCT02379221)
Timeframe: 5-10 minutes post procedure
Intervention | units on a scale (Mean) |
---|---|
Injectable | 0.76 |
Topical | 2.82 |
Participant will complete a questionnaire to evaluate his/her pain level perception using a Visual Analog Scale (VAS) during injection to the upper and lower lip. The Visual Analog scale uses a 10 cm horizontal line with 'no pain' labeled on the left end of line and 'worst pain' on the right end of line. Participant marks their pain level at any point on the line from no pain to worst pain. No pain= 0 cm, Worst pain=10cm (NCT02379221)
Timeframe: 5-10 minutes post-procedure
Intervention | unit on a scale (Mean) |
---|---|
Upper Lip | 2.14 |
Lower Lip | 1.89 |
Participant will complete a questionnaire to evaluate his/her pain level perception using a Visual Analog Scale (VAS) during application of topical anesthesia to the upper and lower lip. The Visual Analog scale uses a 10 cm horizontal line with 'no pain' labeled on the left end of line and 'worst pain' on the right end of line. Participant marks their pain level at any point on the line from no pain to worst pain. No pain= 0 cm, Worst pain=10cm (NCT02379221)
Timeframe: 5-10 min post procedure
Intervention | units on a scale (Mean) |
---|---|
Upper Lip | 0.05 |
Lower Lip | 0.11 |
Patient will complete a questionnaire to evaluate his/her preference of anesthetic modality. (NCT02379221)
Timeframe: one week post treatment
Intervention | participant preference selection (Number) |
---|---|
Injectable | 32 |
Topical | 16 |
Evaluate pain on an 11-point scale, where 0 is no pain and 10 is the worst pain imaginable. (NCT00653861)
Timeframe: 1 day
Intervention | Units on a scale (Mean) |
---|---|
Juvéderm Lidocaine Nasolabial Folds (NLFs) | 2.0 |
Juvéderm Nasolabial Folds (NLFs) | 5.4 |
A 5-point scale (-2 = Right NLF more painful than Left NLF; -1 = Right NLF slightly more painful than Left NLF; 0 = No difference; 1 = Left NLF slightly more painful than Right NLF; 2 = Left NLF more painful than Right NLF). Subjects selected one category from the scale; the percentage of subjects that selected each category is presented. (NCT00653861)
Timeframe: 1 day
Intervention | Percent of Participants (Number) | ||||
---|---|---|---|---|---|
Juvéderm Lidocaine is Less Painful than Juvéderm | Juvéderm Lidocaine is Slightly Less Painful | No Difference | Juvéderm Lidocaine is Slightly More Painful | Juvéderm Lidocaine is More Painful than Juvéderm | |
Total Study Participants | 64 | 29 | 0 | 4 | 3 |
Determination of improvement in NLF severity score on 5-point NLF Severity Scale (0 = None; 1 = Mild; 2 = Moderate; 3 = Severe; 4 = Extreme) two weeks after treatment with Juvederm with Lidocaine (either Ultra or Ultra Plus) in one nasolabial fold and Juvederm (either Ultra or Ultra Plus) in the other nasolabial fold. (NCT00653861)
Timeframe: 2 weeks
Intervention | Units on a scale (Mean) | |
---|---|---|
Improvement using Juvederm Ultra | Improvement using Juvederm Ultra Plus | |
Juvéderm Lidocaine NLFs | 1.6 | 1.8 |
Juvéderm NLFs | 1.6 | 1.8 |
1 review available for lidocaine and Skin Aging
Article | Year |
---|---|
Complications from Nasolabial Fold Injection of Calcium Hydroxylapatite for Facial Soft-Tissue Augmentation: A Systematic Review and Meta-Analysis.
Topics: Anesthetics, Local; Biocompatible Materials; Cosmetic Techniques; Durapatite; Humans; Injections; Li | 2016 |
35 trials available for lidocaine and Skin Aging
Article | Year |
---|---|
A Randomized, Comparator-Controlled Study of HARC for Cheek Augmentation and Correction of Midface Contour Deficiencies.
Topics: Adult; Aged; Aged, 80 and over; Cheek; Cosmetic Techniques; Dermal Fillers; Esthetics; Female; Human | 2021 |
Effectiveness and Safety of Calcium Hydroxylapatite With Lidocaine for Improving Jawline Contour.
Topics: Calcium; Cosmetic Techniques; Durapatite; Esthetics; Humans; Lidocaine; Patient Satisfaction; Skin A | 2021 |
A randomized, multicenter study on a flexible hyaluronic acid filler in treatment of moderate-to-severe nasolabial folds in a Chinese population.
Topics: Adult; China; Cosmetic Techniques; Dermal Fillers; Double-Blind Method; Excipients; Humans; Hyaluron | 2022 |
Lifting the midface using a hyaluronic acid filler with lidocaine: A randomized multi-center study in a Chinese population.
Topics: Adult; Cosmetic Techniques; Dermal Fillers; East Asian People; Humans; Hyaluronic Acid; Lidocaine; P | 2022 |
Patient Comfort, Safety, and Effectiveness of Resilient Hyaluronic Acid Fillers Formulated With Different Local Anesthetics.
Topics: Anesthetics, Local; Cosmetic Techniques; Dermal Fillers; Double-Blind Method; Humans; Hyaluronic Aci | 2022 |
Reduced pain with injection of hyaluronic acid with pre-incorporated lidocaine for nasolabial fold correction: A multicenter, double-blind, randomized, active-controlled, split-face designed, clinical study.
Topics: Cosmetic Techniques; Dermal Fillers; Double-Blind Method; Humans; Hyaluronic Acid; Lidocaine; Nasola | 2020 |
Safety and Effectiveness of Hyaluronic Acid Fillers With Lidocaine for Full-Face Treatment in Asian Patients.
Topics: Adult; Asian People; Dermal Fillers; Drug Combinations; Esthetics; Female; Humans; Hyaluronic Acid; | 2020 |
A Randomized, Evaluator-Blind, Split-Face Study Evaluating the Safety and Efficacy of Calcium Hydroxylapatite for Jawline Augmentation.
Topics: Adult; Aged; Cannula; Dermal Fillers; Durapatite; Esthetics; Female; Healthy Volunteers; Humans; Inj | 2022 |
Assessment of clinical efficacy of lidocaine/tetracaine 7%/7% peel cream in fractional microablative laser procedure-associated pain for facial skin aging treatment. A randomized, controlled, single-blind trial.
Topics: Adult; Anesthetics, Local; Emollients; Female; Humans; Lidocaine; Male; Middle Aged; Pain; Prospecti | 2022 |
A Randomized Study on PLLA Using Higher Dilution Volume and Immediate Use Following Reconstitution.
Topics: Cosmetic Techniques; Dermal Fillers; Female; Humans; Hyaluronic Acid; Indicator Dilution Techniques; | 2021 |
Hyaluronic Acid Gel With (HARRL) and Without Lidocaine (HAJU) for the Treatment of Moderate-to-Severe Nasolabial Folds: A Randomized, Evaluator-Blinded, Phase III Study.
Topics: Adult; Aged; Anesthetics, Local; Cosmetic Techniques; Dermal Fillers; Female; Gels; Humans; Hyaluron | 2018 |
Comparison of Hyaluronic Acid Gel With (HARDL) and Without Lidocaine (HAJUP) in the Treatment of Moderate-To-Severe Nasolabial Folds: A Randomized, Evaluator-Blinded Study.
Topics: Adult; Aged; Anesthetics, Local; Cosmetic Techniques; Dermal Fillers; Double-Blind Method; Drug Ther | 2018 |
Topical Transdermally Delivered Lidocaine and Benzocaine Compared to Compounded Lidocaine/Tetracaine During Microfocused Ultrasound With Visualization Treatment.
Topics: Administration, Cutaneous; Adult; Anesthetics, Local; Benzocaine; Double-Blind Method; Drug Combinat | 2018 |
Safe, Effective Chin and Jaw Restoration With VYC-25L Hyaluronic Acid Injectable Gel.
Topics: Adult; Aged; Chin; Cosmetic Techniques; Dermal Fillers; Drug Combinations; Esthetics; Female; Humans | 2019 |
The evaluation of hyaluronic acid, with and without lidocaine, in the filling of nasolabial folds as measured by ultrastructural changes and pain management.
Topics: Adult; Aged; Anesthetics, Local; Cosmetic Techniques; Double-Blind Method; Female; Follow-Up Studies | 2013 |
Topical lidocaine enhanced by laser pretreatment: a safe and effective method of analgesia for facial rejuvenation.
Topics: Administration, Cutaneous; Analgesia; Analysis of Variance; Anesthetics, Combined; Anesthetics, Loca | 2013 |
Topical lidocaine enhanced by laser pretreatment: a safe and effective method of analgesia for facial rejuvenation.
Topics: Administration, Cutaneous; Analgesia; Analysis of Variance; Anesthetics, Combined; Anesthetics, Loca | 2013 |
Topical lidocaine enhanced by laser pretreatment: a safe and effective method of analgesia for facial rejuvenation.
Topics: Administration, Cutaneous; Analgesia; Analysis of Variance; Anesthetics, Combined; Anesthetics, Loca | 2013 |
Topical lidocaine enhanced by laser pretreatment: a safe and effective method of analgesia for facial rejuvenation.
Topics: Administration, Cutaneous; Analgesia; Analysis of Variance; Anesthetics, Combined; Anesthetics, Loca | 2013 |
Topical lidocaine enhanced by laser pretreatment: a safe and effective method of analgesia for facial rejuvenation.
Topics: Administration, Cutaneous; Analgesia; Analysis of Variance; Anesthetics, Combined; Anesthetics, Loca | 2013 |
Topical lidocaine enhanced by laser pretreatment: a safe and effective method of analgesia for facial rejuvenation.
Topics: Administration, Cutaneous; Analgesia; Analysis of Variance; Anesthetics, Combined; Anesthetics, Loca | 2013 |
Topical lidocaine enhanced by laser pretreatment: a safe and effective method of analgesia for facial rejuvenation.
Topics: Administration, Cutaneous; Analgesia; Analysis of Variance; Anesthetics, Combined; Anesthetics, Loca | 2013 |
Topical lidocaine enhanced by laser pretreatment: a safe and effective method of analgesia for facial rejuvenation.
Topics: Administration, Cutaneous; Analgesia; Analysis of Variance; Anesthetics, Combined; Anesthetics, Loca | 2013 |
Topical lidocaine enhanced by laser pretreatment: a safe and effective method of analgesia for facial rejuvenation.
Topics: Administration, Cutaneous; Analgesia; Analysis of Variance; Anesthetics, Combined; Anesthetics, Loca | 2013 |
Topical lidocaine enhanced by laser pretreatment: a safe and effective method of analgesia for facial rejuvenation.
Topics: Administration, Cutaneous; Analgesia; Analysis of Variance; Anesthetics, Combined; Anesthetics, Loca | 2013 |
Topical lidocaine enhanced by laser pretreatment: a safe and effective method of analgesia for facial rejuvenation.
Topics: Administration, Cutaneous; Analgesia; Analysis of Variance; Anesthetics, Combined; Anesthetics, Loca | 2013 |
Topical lidocaine enhanced by laser pretreatment: a safe and effective method of analgesia for facial rejuvenation.
Topics: Administration, Cutaneous; Analgesia; Analysis of Variance; Anesthetics, Combined; Anesthetics, Loca | 2013 |
Topical lidocaine enhanced by laser pretreatment: a safe and effective method of analgesia for facial rejuvenation.
Topics: Administration, Cutaneous; Analgesia; Analysis of Variance; Anesthetics, Combined; Anesthetics, Loca | 2013 |
Topical lidocaine enhanced by laser pretreatment: a safe and effective method of analgesia for facial rejuvenation.
Topics: Administration, Cutaneous; Analgesia; Analysis of Variance; Anesthetics, Combined; Anesthetics, Loca | 2013 |
Topical lidocaine enhanced by laser pretreatment: a safe and effective method of analgesia for facial rejuvenation.
Topics: Administration, Cutaneous; Analgesia; Analysis of Variance; Anesthetics, Combined; Anesthetics, Loca | 2013 |
Topical lidocaine enhanced by laser pretreatment: a safe and effective method of analgesia for facial rejuvenation.
Topics: Administration, Cutaneous; Analgesia; Analysis of Variance; Anesthetics, Combined; Anesthetics, Loca | 2013 |
Safety and effectiveness of injection of calcium hydroxylapatite via blunt cannula compared to injection by needle for correction of nasolabial folds.
Topics: Aged; Anesthetics, Local; Catheters; Contusions; Cosmetic Techniques; Durapatite; Edema; Erythema; F | 2014 |
A randomized, evaluator-blinded, controlled study of effectiveness and safety of small particle hyaluronic acid plus lidocaine for lip augmentation and perioral rhytides.
Topics: Adolescent; Aged; Anesthetics, Local; Contusions; Cosmetic Techniques; Edema; Female; Gels; Humans; | 2015 |
A blinded, randomized, split-face pilot study of bruising and pain with hyaluronic acid for correction of perioral lines using no lidocaine, lidocaine alone, and lidocaine and epinephrine.
Topics: Adult; Aged; Anesthetics, Local; Contusions; Cosmetic Techniques; Double-Blind Method; Epinephrine; | 2015 |
The Efficacy and Safety of Lidocaine-Containing Hyaluronic Acid Dermal Filler for Treatment of Nasolabial Folds: A Multicenter, Randomized Clinical Study.
Topics: Adult; Aged; Cosmetic Techniques; Dermal Fillers; Double-Blind Method; Female; Humans; Hyaluronic Ac | 2015 |
A Randomized Clinical Trial to Evaluate the Efficacy and Safety of Lidocaine-Containing Monophasic Hyaluronic Acid Filler for Nasolabial Folds.
Topics: Adult; Aged; Confidence Intervals; Dermal Fillers; Double-Blind Method; Drug Combinations; Esthetics | 2016 |
Effectiveness and Safety of Large Gel Particle Hyaluronic Acid With Lidocaine for Correction of Midface Volume Deficit or Contour Deficiency.
Topics: Anesthetics, Local; Cosmetic Techniques; Esthetics; Face; Female; Gels; Humans; Hyaluronic Acid; Lid | 2016 |
Calcium Hydroxylapatite With Integral Lidocaine Provides Improved Pain Control for the Correction of Nasolabial Folds.
Topics: Adult; Aged; Double-Blind Method; Drug Carriers; Drug Implants; Durapatite; Female; Follow-Up Studie | 2016 |
The Efficacy and Safety of HA IDF Plus (with Lidocaine) Versus HA IDF (Without Lidocaine) in Nasolabial Folds Injection: A Randomized, Multicenter, Double-Blind, Split-Face Study.
Topics: Adult; Anesthetics, Local; Dermal Fillers; Double-Blind Method; Female; Humans; Hyaluronic Acid; Lid | 2017 |
A multicenter, randomized, double-blind clinical study to evaluate the efficacy and safety of a new monophasic hyaluronic acid filler with lidocaine 0.3% in the correction of nasolabial fold.
Topics: Anesthetics, Local; Cosmetic Techniques; Dermal Fillers; Double-Blind Method; Female; Humans; Hyalur | 2017 |
A split-face comparison of a new hyaluronic acid facial filler containing pre-incorporated lidocaine versus a standard hyaluronic acid facial filler in the treatment of naso-labial folds.
Topics: Anesthetics, Local; Cosmetic Techniques; Drug Combinations; Face; Female; Humans; Hyaluronic Acid; I | 2009 |
A multi-center, double-blind, randomized controlled study of the safety and effectiveness of Juvéderm injectable gel with and without lidocaine.
Topics: Adult; Aged; Aged, 80 and over; Anesthetics, Local; Double-Blind Method; Female; Functional Laterali | 2009 |
A multi-center, double-blind, randomized controlled study of the safety and effectiveness of Juvéderm injectable gel with and without lidocaine.
Topics: Adult; Aged; Aged, 80 and over; Anesthetics, Local; Double-Blind Method; Female; Functional Laterali | 2009 |
A multi-center, double-blind, randomized controlled study of the safety and effectiveness of Juvéderm injectable gel with and without lidocaine.
Topics: Adult; Aged; Aged, 80 and over; Anesthetics, Local; Double-Blind Method; Female; Functional Laterali | 2009 |
A multi-center, double-blind, randomized controlled study of the safety and effectiveness of Juvéderm injectable gel with and without lidocaine.
Topics: Adult; Aged; Aged, 80 and over; Anesthetics, Local; Double-Blind Method; Female; Functional Laterali | 2009 |
Reduced pain with use of proprietary hyaluronic acid with lidocaine for correction of nasolabial folds: a patient-blinded, prospective, randomized controlled trial.
Topics: Adult; Aged; Anesthetics, Local; Cosmetic Techniques; Dermatologic Agents; Female; Humans; Hyaluroni | 2010 |
Longevity of effects of hyaluronic acid plus lidocaine facial filler.
Topics: Adult; Aged; Dermatologic Agents; Double-Blind Method; Drug Combinations; Europe; Face; Female; Foll | 2010 |
Safety of lidocaine 15% and prilocaine 5% topical ointment used as local anesthesia for intense pulsed light treatment.
Topics: Administration, Cutaneous; Adult; Aged; Anesthesia, Local; Anesthetics, Local; Cosmetic Techniques; | 2010 |
A lidocaine-containing formulation of large-gel particle hyaluronic acid alleviates pain.
Topics: Anesthetics, Local; Dose-Response Relationship, Drug; Double-Blind Method; Drug Combinations; Face; | 2010 |
Short review on face rejuvenation procedures: focus on preoperative antiseptic and anesthetic delivery by JetPeel™-3 (a high pressure oxygen delivery device).
Topics: Administration, Cutaneous; Adult; Aged; Anesthesia, Local; Anesthetics, Local; Chemexfoliation; Chlo | 2011 |
Full-face laser resurfacing using a supplemented topical anesthesia protocol.
Topics: Acne Vulgaris; Administration, Topical; Anesthetics, Local; Cicatrix; Face; Female; Follow-Up Studie | 2003 |
A trial of short incubation, broad-area photodynamic therapy for facial actinic keratoses and diffuse photodamage.
Topics: Administration, Topical; Adult; Aged; Aminolevulinic Acid; Anesthetics, Local; Facial Dermatoses; Fe | 2004 |
EMLA cream application without occlusive dressing before upper facial botulinum toxin injection: a randomized, double-blind, placebo-controlled trial.
Topics: Adult; Anesthetics, Local; Botulinum Toxins, Type A; Double-Blind Method; Face; Female; Humans; Lido | 2008 |
41 other studies available for lidocaine and Skin Aging
Article | Year |
---|---|
Nonsurgical lower eyelid rejuvenation using injectable poly-d,l-lactic acid in Asian patients.
Topics: Cosmetic Techniques; Eyelids; Humans; Hyaluronic Acid; Lidocaine; Rejuvenation; Skin Aging | 2022 |
Calcium Hydroxyapatite Filler With Integral Lidocaine CaHA (+) for Soft Tissue Augmentation: Results from an Open-Label Multicenter Clinical Study.
Topics: Calcium; Cosmetic Techniques; Dermal Fillers; Durapatite; Humans; Hyaluronic Acid; Lidocaine; Nasola | 2022 |
Microcannula Injection of Large Gel Particle Hyaluronic Acid for Cheek Augmentation and the Correction of Age-Related Midface Contour Deficiencies.
Topics: Adult; Aged; Cannula; Cheek; Cosmetic Techniques; Dermal Fillers; Esthetics; Female; Gels; Humans; H | 2020 |
Minilifting technique for treatments of the lower third of the face and anterior cervical neck with tumescent anesthesia.
Topics: Anesthesia, Local; Anesthetics, Local; Face; Female; Humans; Lidocaine; Middle Aged; Minimally Invas | 2020 |
Correction of temporal wasting using calcium hydroxylapatite with integral lidocaine: An underused procedure for enhancing overall facial appearance.
Topics: Adult; Aged; Calcium; Child, Preschool; Cosmetic Techniques; Durapatite; Humans; Lidocaine; Middle A | 2021 |
A prospective, open label, multicenter, postmarket study evaluating Princess VOLUME Lidocaine for the correction of nasolabial folds.
Topics: Cosmetic Techniques; Female; Humans; Hyaluronic Acid; Lidocaine; Middle Aged; Nasolabial Fold; Prosp | 2020 |
Immediate Use After Reconstitution of a Biostimulatory Poly-L-Lactic Acid Injectable Implant.
Topics: Cellulose; Cosmetic Techniques; Dermal Fillers; Drug Implants; Drug Stability; Excipients; Humans; I | 2020 |
A prospective, open-label, multicentric, single-arm, post-marketing clinical study to evaluate effectiveness and safety of Cross-Linked Sodium Hyaluronate 24mg with Lidocaine 3mg Injection in subjects undergoing treatment for facial wrinkles and lip augme
Topics: Adolescent; Adult; Aged; Cosmetic Techniques; Dermal Fillers; Humans; Hyaluronic Acid; Lidocaine; Li | 2021 |
Pilot Study Examining the Safety and Efficacy of Calcium Hydroxylapatite Filler With Integral Lidocaine Over a 12-Month Period to Correct Temporal Fossa Volume Loss.
Topics: Anesthetics, Local; Cosmetic Techniques; Dermal Fillers; Durapatite; Esthetics; Female; Humans; Inje | 2018 |
Diluted Calcium Hydroxylapatite for Skin Tightening of the Upper Arms and Abdomen.
Topics: Abdomen; Adult; Arm; Biocompatible Materials; Collagen; Cosmetic Techniques; Durapatite; Elasticity; | 2017 |
Predictive Techniques for Neurotoxin Outcomes.
Topics: Adult; Anesthetics, Local; Botulinum Toxins, Type A; Cosmetic Techniques; Face; Humans; Injections, | 2018 |
A Novel, Optimized Method to Accelerate the Preparation of Injectable Poly-L-Lactic Acid by Sonication.
Topics: Absorbable Implants; Anesthetics, Local; Cellulose; Cosmetic Techniques; Humans; Injections, Subcuta | 2018 |
Rheological Properties of Several Hyaluronic Acid-Based Gels: A Comparative Study.
Topics: Cosmetic Techniques; Drug Combinations; Gels; Humans; Hyaluronic Acid; Lidocaine; Rheology; Skin Agi | 2018 |
Hyaluronic acid gel based on CPM
Topics: Anesthetics, Local; Cosmetic Techniques; Dermal Fillers; Dermis; Gels; Humans; Hyaluronic Acid; Lido | 2019 |
Open-Label, Post-Marketing Study to Evaluate the Performance and Safety of Calcium Hydroxylapatite With Integral Lidocaine to Correct Facial Volume Loss
Topics: Adult; Aged; Anesthetics, Local; Dermal Fillers; Drug Combinations; Durapatite; Facial Dermatoses; F | 2019 |
Ice anaesthesia in procedural dermatology.
Topics: Adult; Aluminum; Anesthesia, Local; Australia; Botulinum Toxins, Type A; Cryoanesthesia; Dermatology | 2013 |
Efficacy and safety of and patient satisfaction with injectable hyaluronic acid with 0.3% lidocaine hydrochloride for the treatment of superficial perioral lines or superficial lateral canthal lines.
Topics: Adult; Aged; Biocompatible Materials; Cosmetic Techniques; Dermatologic Agents; Female; Gels; Granul | 2013 |
Botulinum toxin type A reconstituted in lidocaine with epinephrine for facial rejuvenation: results of a participant satisfaction survey.
Topics: Adult; Aged; Botulinum Toxins, Type A; Epinephrine; Facial Muscles; Feasibility Studies; Female; Fol | 2013 |
Midface and perioral volume restoration: a conversation between the US and Italy.
Topics: Adult; Aged; Aged, 80 and over; Cosmetic Techniques; Dermatologic Agents; Face; Female; Humans; Hyal | 2014 |
Review of the safety profile for microfocused ultrasound with visualization.
Topics: Anesthetics, Local; Clinical Trials as Topic; Contusions; Edema; Erythema; Humans; Lidocaine; Produc | 2014 |
Wrinkling over finger tip.
Topics: Child; Fingers; Humans; Lidocaine; Lidocaine, Prilocaine Drug Combination; Male; Prilocaine; Skin; S | 2015 |
Ultrastructural analysis of 3 hyaluronic acid soft-tissue fillers using scanning electron microscopy.
Topics: Anesthetics, Local; Cosmetic Techniques; Gels; Humans; Hyaluronic Acid; Injections, Intradermal; Lid | 2015 |
The use of nontraditional fillers and neuromodulators to improve patient satisfaction.
Topics: Botulinum Toxins; Cosmetic Techniques; Esthetics; Face; Humans; Lidocaine; Neurotransmitter Agents; | 2015 |
A prospective, comparative survey to investigate practitioners' satisfaction with a cohesive, polydensified-matrix(®) , hyaluronic acid-based filler gel with and without lidocaine for the treatment of facial wrinkles.
Topics: Adult; Aged; Aged, 80 and over; Anesthetics, Local; Attitude of Health Personnel; Cosmetic Technique | 2015 |
[Lidocaine-containing hyaluronic acid filler on a CPM® basis for lip augmentation : Experience from clinical practice].
Topics: Adult; Anesthetics, Local; Cosmetic Techniques; Cosmetics; Dermal Fillers; Drug Combinations; Facial | 2016 |
A Randomized Clinical Trial to Evaluate the Efficacy and Safety of Lidocaine-Containing Monophasic Hyaluronic Acid Filler for Nasolabial Folds.
Topics: Cosmetic Techniques; Humans; Hyaluronic Acid; Lidocaine; Nasolabial Fold; Skin Aging | 2016 |
[Tissue augmentation with hyaluronic acid fillers--practical procedure].
Topics: Aftercare; Anesthetics, Local; Biocompatible Materials; Gels; Humans; Hyaluronic Acid; Injections, I | 2008 |
European evaluation of a new hyaluronic acid filler incorporating lidocaine.
Topics: Adjuvants, Immunologic; Anesthetics, Local; Cosmetic Techniques; Drug Combinations; Europe; Face; Fe | 2008 |
A novel approach to treatment of the aging hand with Radiesse.
Topics: Cosmetic Techniques; Durapatite; Hand; Humans; Lidocaine; Skin Aging | 2009 |
Letter: fine rhytides treated with porcine collagen-derived filler mixed with anesthetic.
Topics: Animals; Collagen; Epinephrine; Humans; Injections, Subcutaneous; Lidocaine; Rhytidoplasty; Skin Agi | 2010 |
A single injection technique for midface rejuvenation.
Topics: Face; Female; Humans; Hyaluronic Acid; Injections; Lidocaine; Maxilla; Patient Care Planning; Rejuve | 2010 |
Additional commentary on "addition of lidocaine to fillers".
Topics: Anesthetics, Local; Biocompatible Materials; Cosmetic Techniques; Drug Combinations; Durapatite; Hum | 2010 |
Benefits of adding lidocaine to a hyaluronic gel - Stylage® M.
Topics: Adult; Aged; Anesthetics, Local; Dermatologic Agents; Drug Combinations; Esthetics; Female; Humans; | 2011 |
[Facial angioedema following hyaluronic acid injection].
Topics: Angioedema; Anti-Inflammatory Agents; Dermatologic Agents; Drug Eruptions; Drug Therapy, Combination | 2012 |
A complete range of hyaluronic acid filler with distinctive physical properties specifically designed for optimal tissue adaptations.
Topics: Calibration; Cosmetic Techniques; Cross-Linking Reagents; Gels; Humans; Hyaluronic Acid; Lidocaine; | 2012 |
Water immersion and EMLA cause similar digit skin wrinkling and vasoconstriction.
Topics: Adult; Female; Humans; Immersion; Lidocaine; Lidocaine, Prilocaine Drug Combination; Male; Ointments | 2003 |
Soft tissue augmentation using artecoll: a personal experience.
Topics: Biocompatible Materials; Collagen; Female; Humans; Injections, Intradermal; Lidocaine; Male; Microsp | 2004 |
Safe and effective carbon dioxide laser skin resurfacing of the neck.
Topics: Anesthetics, Combined; Anesthetics, Local; Carbon Dioxide; Dermatologic Surgical Procedures; Humans; | 2006 |
Dermabrasion using tumescent anesthesia.
Topics: Acne Vulgaris; Adult; Anesthesia, Local; Anesthetics, Local; Bicarbonates; Cicatrix; Dermabrasion; D | 1994 |
Laser peel: facial rejuvenation with a superficial erbium:YAG laser treatment.
Topics: Adult; Aged; Anesthetics, Local; Erbium; Erythema; Female; Humans; Laser Therapy; Lidocaine; Lidocai | 2000 |
Application of the tumescent technique to hand augmentation.
Topics: Adipose Tissue; Anesthesia, Local; Bicarbonates; Catheterization; Hand; Humans; Lidocaine; Lipectomy | 1990 |