Post-inflammatory hyperpigmentation (PIH) is the most common disorder and presents a complaint of pigmentation, especially in people with skin of color. PIH is associated with a significant psychological burden and decreasein the quality of life. The management options for post- inflammatory hyperpigmentation include topical lightening agents, photoprotection, lasers and energy devices. 

The clinical trials of melasma have reported a diversity of outcomes, often hindering the synthesis of results across the trials, or comparison of results that is associated with different modalities of treatment. The protocol defines the design of a consensus procedure culminating in the development of anessential set of outcomes to be evaluated in all clinical trials for post inflammatory hyperpigmentation. Anextended list of candidate outcomes is developed through a systematic review, and is combined with semi-structured interviews with several stakeholders, which includes patients, regulators, scientists, and health care professionals. This long list of outcomes is then reviewed and refined by a steering committee. There are two rounds of Delphi surveys of patient and physician groups and is used to reject the list, with short-term inclusion of those items and is deemed "important" by 70% of the respondents. 

A consensus meeting might be held virtually or in person for voting for these items, and also consider any changes that are necessary before acceptance of a final fundamental outcome set. Development of anessential outcome set for post-inflammatory hyperpigmentation is projected to improve and standardize the outcomes that were reported in present and future clinical trials. This mightenablethe accumulation of research results and also allow the comparison of outcomes throughoutthe multiple studies.

Source: Kang BY, Ibrahim SA, Shokeen D, et al. Postinflammatory hyperpigmentation: protocol for development of a core outcome set for clinical trials. Arch Dermatol Res. 2021 May 21. doi: 10.1007/s00403-021-02239-6. Epub ahead of print. PMID: 34019133.