Skip to content

Core Outcome Set for Melasma




Melasma is a configurate, patchy brown to dark gray pigmentation of the face that is often mediated by sun exposure and hormonal effects. Prevalence is worldwide, and across age groups, particularly among patients with darker skin types.  While patients often find melasma distressing, disfiguring and stigmatizing, topical, oral and device treatments are variably effective, and assessment of treatment effects can be difficult to measure.   A standardized core outcome set for melasma would facilitate research on this condition by allowing comparability of study results across sub-populations and geographic regions.  Uniformity of study outcomes may also encourage meta-analyses of smaller studies, thereby enabling identification of better tolerated and more effective therapies.

Scope of the intended COS

  • Study types: e.g. RCTs: RCTs or Controlled Clinical Trials
  • Region, e.g. global scope: Global scope


We aim to develop a core outcome set by (1) identifying all current outcomes from a systematic review of literature; (2) involving other stakeholder groups such as other clinicians, and regulators to participate in identifying additional outcomes; (3) conducting Delphi consensus exercises on the identified outcomes; (4) presenting all results from the Delphi exercises during a face-to-face (if possible) consensus meeting to vote and agree upon a core set of outcomes important for melasma research.

Involvement of stakeholders

Stakeholders, or those invested in the development of a core outcome set, will also be included in the decision process, along with patients. Dermatologists, and industry scientists associated treatments for melasma are potential members that can provide input regarding what outcomes they feel should be represented. Nurses, physician assistants, and other health care practitioners may be included as well to enhance further discussion.

Current status

Protocol development


Departmental research funds

Involved Countries


Date of updates

  • 10/08/2020


  • Murad Alam, MD

Project team members

Steering Committee:

  • Murad Alam, MD
  • Joseph F. Sobanko, MD
  • Ian A. Maher, MD
  • Todd V. Cartee, MD

Responsible member of Methods group (as assigned by CS-COUSIN)

  • Jamie Kirkham, PhD


Murad Alam, MD (

Published references