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Development of a Core Outcome Domain Set for Facial Aging
McKenzie A Dirr1, Areeba Ahmed1, Daniel I Schlessinger2,3
1Department of Dermatology, Northwestern University Feinberg School of Medicine, Chicago, Illinois.
JAMA Dermatology
|June 17, 2026
Summary
Standardized outcome measures for facial aging clinical trials are lacking. A new core outcome set (COS) with 6 domains, including patient satisfaction and treatment convenience, is recommended for future studies.
Area of Science:
- Aesthetics and Regenerative Medicine
- Clinical Trial Methodology
- Dermatology
Background:
- Clinical trials for facial aging interventions lack standardized outcome domains and measures.
- This heterogeneity hinders direct comparison of treatments, identification of superior therapies, and development of high-quality meta-analyses.
Purpose of the Study:
- To develop a core outcome set (COS) of essential domains for reporting in clinical trials evaluating facial aging interventions.
- To ensure consistency and comparability in assessing the efficacy and safety of treatments for facial aging.
Main Methods:
- Comprehensive literature search of multiple databases (PubMed/Medline, Embase, Cochrane, CINAHL) from 2005 to 2026.
- Inclusion of randomized clinical trials and controlled clinical trials assessing facial aging interventions in human participants.
- Utilized two rounds of Delphi surveys with patient and physician stakeholders, followed by consensus meetings, to identify key outcome domains.
Main Results:
- A core outcome set (COS) comprising 6 essential domains was established.
- The domains include: overall treatment convenience, return to normal activities, overall assessment of treatment benefit, duration of effect, adverse event severity, and patient satisfaction.
Conclusions:
- The recommended 6 outcome domains provide a standardized framework for future facial aging clinical trials.
- Implementing this COS will ensure that outcomes most important to patients and clinicians are consistently measured, enhancing result comparability across studies.
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