Development of a Core Outcome Domain Set for Facial Aging.
Recommended Citation
Dirr MA, Ahmed A, Schlessinger DI, Lazaro-Camp V, Smith S, Gullapalli T, Dragovic D, Chang J, Zhang E, Alam M, Anvery N, Christensen RE, Ibrahim SA, Kang BY, Wong C, Iyengar S, Yanes AF, Cotseones J, Ashchyan HJ, Patel PM, Sheikh UA, Franklin MJ, Hanna CC, Chiren SG, Schmitt J, Furlan KC, Alexiades M, Alhusayen R, Alster TS, Beer K, Bertucci V, Bloom JD, Briceño CA, Bucay V, Butterwick KJ, Hugues C, Casabona G, Connolly KL, Cotofana S, Council ML, Cox SE, Darmanescu M, De Boulle K, Desai S, Donofrio LM, Dover JS, Draelos Z, Eisen DB, El-Domyati M, El-Garem Y, Fischer J, Fitzgerald R, Friedmann DP, Galadari H, Gladstone HB, Goldman MP, Goodman GJ, Green JB, Halachmi S, Hanke CW, Humphrey S, Ibrahim SF, Jagdeo J, Jiang SIB, Karen JK, Kauvar A, Kibbi AG, Kim JVS, Kim J, de Lacerda D, Lask G, Lopez GM, Lupo MP, Mariwalla K, Matarasso S, Mekokishvili L, Narins RS, Ogilvie P, Orringer JS, Osaki TH, Ozog D, Pacheco T, Polder K, Rossi AM, Sadick N, Saedi N, Schlessinger J, Sharad J, Shenoy MM, Sinclair R, Solish N, Piansay-Soriano ME, Sulyman O, Szeimies RM, Tanzi EL, Taub AF, Taylor MB, Thomas JR, Torezan L, Tosti A, Touma D, Trindade de Almeida AR, Vedamurthy M, Viana G, Waldman A, Weinkle SH, Weiss R, Poon E, Maher IA, Cartee TV, Sobanko JF, Kirkham JJ. Development of a Core Outcome Domain Set for Facial Aging. JAMA Dermatol. 2026;162(8):829-836.
Document Type
Article
Publication Date
8-1-2026
Publication Title
JAMA Dermatol
Keywords
Humans, Skin Aging, Face, Delphi Technique, Randomized Controlled Trials as Topic, Cosmetic Techniques, Treatment Outcome, Outcome Assessment, Health Care, Patient Satisfaction, Consensus
Abstract
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.
Medical Subject Headings
Humans; Skin Aging; Face; Delphi Technique; Randomized Controlled Trials as Topic; Cosmetic Techniques; Treatment Outcome; Outcome Assessment, Health Care; Patient Satisfaction; Consensus
PubMed ID
42307924
Volume
162
Issue
8
First Page
829
Last Page
836
