Development of a Core Outcome Domain Set for Facial Aging

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.

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Publication Details

Journal
JAMA Dermatology
Published
2026-06-17
DOI
https://doi.org/10.1001/jamadermatol.2026.1697
Primary Topic
Skin Protection and Aging
Type
article
Field-Weighted Citation Impact
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article

Development of a Core Outcome Domain Set for Facial Aging

Lisa Donofrio, D T D Lacerda, Hovik J. Ashchyan, Rachel E. Christensen et al.
JAMA Dermatology
Skin Protection and Aging
article

Development of a Core Outcome Domain Set for Facial Aging

Lisa Donofrio, D T D Lacerda, Hovik J. Ashchyan, Rachel E. Christensen, Vince Bertucci, Sarah A. Ibrahim, Tina S. Alster, Karen Connolly, Doroteja Dragovic, Shlomit Halachmi, Sarah G. Chiren, Jae‐Joong Kim, Sebastian Cotofana, Nazanin Saedi, Joel Schlessinger, Noor Anvery, SJ Smith, Jason D. Bloom, Arianna F. Yanes, P Ogilvie, Omotara Sulyman, Miriam Emily Piansay‐Soriano, Kibbi Ag, JENNY KIM, Daniel P. Friedmann, L Mekokishvili, Jaishree Sharad, Shang I. Brian Jiang, G Lask, Matthew Franklin, Rolf‐Markus Szeimies, Jeremy B. Green, Bianca Y. Kang, Amy Forman Taub, J Schmitt, Jeffrey S. Orringer, Mary P. Lupo, Kavita Mariwalla, Kimberly J. Butterwick, Courtney Hanna, Luis Torezan, Anthony M Rossi, Rebecca Fitzgerald, Sue Ellen Cox, McKenzie A. Dirr, Daniel B. Eisen, Clarissa Wong, Mark B. Taylor, SuchitraM Shenoy, P. M. Patel, Koenraad De Boulle, J. Regan Thomas, Julie Karen, Sherrif F. Ibrahim, Shraddha Desai, Sanjana Iyengar, Elizabeth L. Tanzi, Umar A. Sheikh, Joycie Chang, C. William Hanke, Rd Sinclair, Thanvi Gullapalli, Elizabeth Zhang, Neil Sadick, Vanessa Lazaro-Camp, Jeffrey S. Dover, Jared Jagdeo, Tammy H. Osaki, Zoe Draelos, Raed Alhusayen, Gabriela Casabona, Shannon Humphrey, David Ozog, Hassan GALADARI, Yehia El-Garem, Cartier Hugues, Macrene Alexiades, Monica Darmanescu, Nowell Solish, Kenneth Beer, Antonella Tosti, Rhoda S. Narins, César A. Briceño, Hayes B. Gladstone, Arielle Kauvar, Moetaz El-Domyati, Daniel I. Schlessinger, Kristel Polder, Jill Cotseones, Greg J. Goodman, Grace M. Lopez, Mitchel P. Goldman, Facial Aging Core Outcome Domain Set Study Group, Seth Matarasso, Vivian Bucay, Murad Alam, Theresa Pacheco, Areeba Ahmed, John Fischer, Karina C. Furlan
article en

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.

JAMA Dermatology
Northwestern University (US), University of North Carolina at Chapel Hill (US), Tulane University (US), West Virginia University (US), Loyola University Medical Center (US), Sunnybrook Health Science Centre (CA), Memorial Sloan Kettering Cancer Center (US), University of Wisconsin–Madison (US), University of British Columbia (CA), Penn Presbyterian Medical Center (US), University of Miami (US), Thomas Jefferson University (US), Yenepoya University (IN), Jinan University (CN), University of California, Los Angeles (US), The University of Melbourne (AU), University of New Mexico (US), Universidade de São Paulo (BR), University of California, San Francisco (US), SUNY Downstate Health Sciences University (US), Georgetown University (US), University of Toronto (CA), United Arab Emirates University (AE), Chestnut Hill College (US), Cornell University (US), University of Michigan (US), Hospital of the University of Pennsylvania (US), Georgetown University Medical Center (US), VA NY Harbor Healthcare System (US), Blackstone (United States) (US), Henry Ford Hospital (US), Yale University (US), University of California San Diego (US), University of Illinois Chicago (US), University of Chicago (US), NYU Langone Health (US), Dermatology Consulting Services (US), East Avenue Medical Center (PH), BC Research (Canada) (CA), Urology San Antonio (US), Heska (United States) (US), Metropolitan Community College (US), Emergency University (US), Palm Beach Neurology (US), Central Military Hospital (NL), St. Vincent Hospital (US), American University of Beirut Medical Center (LB), Cosmetic Laser Dermatology (US), Facial Plastics Surgery Associates (US), Gateway Aesthetic Institute and Laser Center (US), Military University (RU), Knappschaftskrankenhaus Recklinghausen (DE), Dermatology Surgery & Laser Center (US), New York Laser and Skin Care (US), Wellcome / EPSRC Centre for Interventional and Surgical Sciences (GB), Mayo Clinic in Arizona (US), Duke Medical Center (US), Washington Institute of Dermatologic Laser Surgery (US), The Institute of Addiction Medicine (US), Washington University Medical Center (US), Petre Shotadze Tbilisi Medical Academy (GE), Dermatology Treatment & Research Center (US), Davao Medical School Foundation (PH), Skin Research Center (FR), DermSurgery Associates (US), Northwestern Medicine (US), Sociedade Brasileira de Oncologia Clínica (BR), Guangdong Provincial People's Hospital (CN), KPMG (United States) (US), University of California Davis Medical Center (US), University Hospital Carl Gustav Carus (DE), Advanced Dermatology (US), Dermatology Research Center (US), Sunnybrook Hospital (CA), University College London (GB), The University of Texas at San Antonio (US), University of Colorado Anschutz Medical Campus (US), Monash University (AU), New York University (US), University of Nebraska Medical Center (US), Technische Universität Dresden (DE), University of Pennsylvania (US), Penn State Milton S. Hershey Medical Center (US), Alexandria University (EG), The University of Texas Southwestern Medical Center (US), Michigan State University (US), Universidade Federal de São Paulo (BR), Minia University (EG), Vanderbilt University Medical Center (US), Marian University - Indiana (US), Philadelphia University (US)
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Skin Protection and Aging
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