Development of a Core Outcome Domain Set for Facial Aging.

Summary

This Delphi-based consensus, grounded in a systematic evidence review and stakeholder input, defines six core outcome domains that should be reported in facial aging clinical trials. Adoption of these domains will standardize endpoints, enhance comparability across interventions, and better align outcomes with patient priorities.

Key Findings

• A six-domain core outcome set was defined for facial aging trials: convenience, time to social/work return, focused-area assessment at peak effect, duration of effect, severity of persistent adverse events, and patient satisfaction.
• Delphi surveys (two rounds) with patient and physician stakeholders plus consensus meetings drove domain selection after comprehensive database searches and patient interviews.
• The COS targets heterogeneity in outcomes to enable cross-trial comparability and patient-centered assessment.

Clinical Implications

Investigators and sponsors should incorporate these six domains into study protocols and reports for facial aging interventions; journals and regulators can encourage adherence to improve evidence synthesis.

Limitations

• Defines outcome domains but not standardized measurement instruments for each domain.
• English-language publication focus may introduce selection bias and limit global generalizability.

Future Directions

Develop validated, fit-for-purpose instruments for each domain; evaluate feasibility, uptake, and reporting compliance across industry and academic trials.