Citations 2
Development of a Core Outcome Domain Set for Facial Aging
Dirr, McKenzie A. , Ahmed, Areeba, Schlessinger, Daniel I., Lazaro-Camp, Vanessa, Smith, SJ, Gullapalli, Thanvi, Dragovic, Doroteja, Chang, Joycie, Zhang, Elizabeth, Alam, Murad, Group, Facial Aging Core Outcome Domain Set Study, Anvery, Noor , Kang, Bianca Y. , Wong, Clarissa, Iyengar, Sanjana, Yanes, Arianna F. , Cotseones, Jill, Ashchyan, Hovik J. , Patel, P. M., Sheikh, Umar A., Franklin, Matthew , Hanna, Courtney, Chiren, Sarah G., Schmitt, J, Furlan, Karina C., Alexiades, Macrene, Alhusayen, Raed, Alster, Tina S. , Beer, Kenneth, Bertucci, Vince , Bloom, Jason D. , Briceño, César A., Bucay, Vivian, Butterwick, Kimberly J., Hugues, Cartier, Casabona, Gabriela, Connolly, Karen , Cox, Sue Ellen , Darmanescu, Monica, Boulle, Koenraad De , Desai, Shraddha, Donofrio, Lisa, Dover, Jeffrey S., Draelos, Zoe, Eisen, Daniel B. , El-Domyati, Moetaz, El-Garem, Yehia, Fischer, John, Fitzgerald, Rebecca, GALADARI, Hassan, Gladstone, Hayes B., Goldman, Mitchel P., Goodman, Greg J., Hanke, C. William , Humphrey, Shannon, Ibrahim, Sherrif F., Jagdeo, Jared, Karen, Julie, Kauvar, Arielle, Ag, Kibbi, KIM, JENNY, Lacerda, D T D, Lask, G, Lopez, Grace M., Lupo, Mary P. , Mariwalla, Kavita , Matarasso, Seth, Mekokishvili, L, Narins, Rhoda S., Ogilvie, P, Orringer, Jeffrey S. , Osaki, Tammy H. , Ozog, David, Pacheco, Theresa, Polder, Kristel, Rossi, Anthony M, Sadick, Neil, Saedi, Nazanin, Schlessinger, Joel, Sharad, Jaishree , Shenoy, SuchitraM, Sinclair, Rd, Solish, Nowell, Piansay‐Soriano, Miriam Emily , Sulyman, Omotara , Szeimies, Rolf‐Markus , Tanzi, Elizabeth L., Taub, Amy Forman , Taylor, Mark B., Thomas, J. Regan, Torezan, Luis, Tosti, Antonella, Touma, Dany, Almeida, Ada Regina Trindade de , Vedamurthy, Maya , Viana, Giovanni, Waldman, Abigail, Weinkle, Susan, Weiss, Robert, Poon, Emily, Cartee, Todd V. , Sobanko, Joseph F. , Eisen, Daniel B. , Ahmed, Areeba , Schlessinger, Daniel Isaac , Lazaro-Camp, Vanessa J, Christensen, Rachel E. , Ibrahim, Sarah A. , Cotseones, J.K., Umar, Sheikh Ahmad , Furlan, Karina Colossi , Alexiades, Macrene , Alhusayen, Raed , Beer, Kenneth Robert, Briceño, César Augusto , Bucay, Vivian , Casabona, Gabriela , Cotofana, Sebastian , Desai, Shraddha , Dover, Jeffrey S. , Draelos, Zoe Diana , Eisen, Daniel B., El-Domyati, Moetaz M. , El-Garem, Yehia, Fitzgerald, Rebecca, Friedmann, Daniel P. , Galadari, Hassan , Gladstone, Hayes B., Goldman, Mitchel P. , Goodman, Greg , Green, Jeremy B. , Halachmi, Shlomit , Humphrey, Shannon , Jagdeo, Jared R. , Jiang, Shang I. Brian , Kauvar, Arielle N.B. , Kibbi, Abdul‐Ghani , Kim, John V. S., LASK, GARY P., Matarasso, Seth L., Narins, Rhoda S., Ogilvie, Patricia , Osaki, Tammy H. , Pacheco, Theresa , Polder, Kristel D., Saedi, Nazanin, Shenoy, Manjunath , Sinclair, Rod, Solish, Nowell , Torezan, Luís , Tosti, Antonellá , Waldman, Abigail , Weiss, Robert, Maher, Ian A. , Kirkham, Jamie J
JAMA Dermatology | June 17, 2026 | Volume: 162 | Issue: 8 | Pages: 829
10.1001/jamadermatol.2026.1697
Importance Currently, there are no standardized outcome domains or measures in clinical trials for facial aging. Heterogeneity in outcome domains and measurement instruments across clinical trials creates difficulty in directly comparing interventions, determining superior therapies, and developing high-quality meta-analyses. Objective To develop a core outcome set (COS) of essential domains to be reported in clinical trials evaluating the efficacy of interventions for facial aging. Evidence Review PubMed/Medline, Embase, Cochrane Central Register of Controlled Trials, and CINAHL were searched from September 2005 to September 2015. An updated search of the same databases was performed from September 2015 to February 2026. Studies were included if (1) they were randomized clinical trial or controlled clinical trial in design, (2) they assessed the efficacy or safety of an intervention for facial aging, (3) they were published in English, and (4) they involved human participants. Complementary sources, including patient interviews, were used to capture further relevant outcomes. Two rounds of Delphi surveys, followed by consensus meetings, were used to identify outcome domains considered most important by both patient and physician stakeholders. Findings The final COS consists of 6 outcome domains: (1) overall convenience of treatment; (2) time to return to normal work and social activity; (3) overall assessment of focused area of treatment (at the point in time when treatment is expected to provide peak benefit); (4) duration of treatment effect; (5) severity of persistent local or systemic adverse events, including pigmentary change, skin texture change, delayed healing, scarring, and serious adverse events; and (6) patient satisfaction with treatment. Conclusions and Relevance The 6 outcome domains identified through a Delphi consensus are recommended for reporting in future facial aging trials to ensure that outcomes that matter most to patients and clinicians are measured and that results are comparable across interventions.
Efficacy and Safety of RelabotulinumtoxinA Liquid Botulinum Toxin in the Treatment of Lateral Canthal Lines: Results From the Phase 3 READY-2 Study
Ablon, Glynis , Bank, David, Kontis, Theda C., Ibrahim, Sherrif F., Palm, Melanie D., Cox, Sue Ellen , Grunebaum, Lisa D., Goldman, Mitchel P. , Humphrey, Shannon , Coquis-Knezek, Sarah, Grunebaum, Lisa, Rivers, Jason Keller
Dermatologic Surgery | December 18, 2024 | Volume: 51 | Issue: 3 | Pages: 277-283
BACKGROUND RelabotulinumtoxinA (RelaBoNT-A) is a complex-free, ready-to-use, liquid botulinum toxin A. OBJECTIVE Efficacy/safety of RelaBoNT-A treatment for lateral canthal lines (LCL). METHODS Randomized adults received RelaBoNT-A (30 U/side; n = 230) or placebo (n = 73) during a 6-month, double-blind, Ph3 study (Relabotulinumtoxin Aesthetic Development Study-2 [READY-2]). Primary end points (Month 1, maximum smile) comprised: composite ≥2-grade responder rate using concurrent LCL severity investigator live assessment (LCL-ILA) and subject live assessment (LCL-SLA); LCL-ILA 0 (none)/1 (mild) responder rate. Subject satisfaction and adverse events were also reported. RESULTS Month 1 composite ≥2-grade responder rates were 51.8% (RelaBoNT-A) and 1.4% (placebo; (p < .001). Month 1 none/mild LCL-ILA responder rates were 87.2% (RelaBoNT-A) and 11.9% (placebo; p < .001). Onset was reported Day 1 by 34%. At Month 6, LCL-ILA responder rates for RelaBoNT-A remained at 23.3% (none/mild) and 35.9% (≥1-grade improvement). Median return to baseline severity was 24.7 weeks; 64% (RelaBoNT-A group) had not returned to baseline at Month 6. RelaBoNT-A satisfaction was high through Month 6 (71%). Mild/moderate treatment-related adverse events occurred in 6.1% (RelaBoNT-A) and 5.5% (placebo). CONCLUSION RelaBoNT-A (60 U) treatment provided statistically significant improvement of moderate-to-severe LCL. One-third of subjects reported onset within 1 day and improvements were maintained through Month 6. Treatment satisfaction was high. RelaBoNT-A was well tolerated.