Background
Clinical trials of melasma are difficult to compare due to variation in the outcomes reported.
Objective
The purpose of this study was to develop a core set of outcome domains to be assessed in all clinical trials of melasma.
Methods
Identification of outcomes was performed via a literature review. Thereafter, 2 rounds of Delphi surveys were conducted, followed by consensus meetings to determine which outcomes should be in the final core domain set.
Results
Seven core outcomes were recommended: relative intensity of representative area of pigmentation relative to baseline; color of dark spots; area and distribution of pigmentation; overall severity of melasma; patient satisfaction with treatment; quality of life; presence and severity of persistent versus transient treatment-related adverse events.
Limitations
Hormonal and intrinsic vascular factors were not included in the core outcome set due to limited feasibility and lack of routine measurement as outcomes in clinical trials and in clinical practice. Additionally, there were very few Hispanic individuals in the Delphi group, although melasma is very common in Hispanic individuals.
Conclusion
A core outcome set has been developed for melasma trials. Routine use of this may improve comparability and pooling of data emanating from such trials.
The purpose of this COS is to better detect clinical onset of melasma, and measure change in melasma associated with therapy.
ContributorsMcKenzie A Dirr, Areeba Ahmed, Daniel I Schlessinger, Sabrina S Smith, Rachel E Christensen, Thanvi Gullapalli, Joycie Chang, Doroteja Dragovic, Vanessa J Lazaro-Camp, Jennifer C Tang, Noor Anvery, Jochen Schmitt, Jamie J Kirkham, Ian A Maher, Joseph F Sobanko, Todd V Cartee, Brian A Cahn, Emily Poon, Elizabeth Zhang, Murad Alam; Melasma Core Outcome Set Working Group (Melasma COS Working Group)
Disease Category: Skin
Disease Name: Melasma
Age Range: 18 - 85
Sex: Either
Nature of Intervention: Any
- Clinical experts
- Consumers (patients)
- Families
- Governmental agencies
- Methodologists
- Pharmaceutical industry representatives
- COS for clinical trials or clinical research
- COS for practice
- Consensus conference
- Delphi process
- Focus group(s)
- Interview
- Nominal group technique (NGT)
- Systematic review
Systematic review of outcomes followed by involvement of key stakeholders using interview/focus group/Delphi process. Consolidation of results using NGT and consensus conference.