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Background <p>Keloids disproportionately affect individuals with darker Fitzpatrick skin types; however, it is unclear whether this is reflected in clinical trial reporting. This systematic review evaluates current reporting practices of Fitzpatrick skin type in adult keloid clinical trials, including documentation of skin tone, quantification of Fitzpatrick skin type, and outcome stratification. </p> Methods <p>A systematic review was conducted in accordance with PRISMA guidelines using Ovid MEDLINE, PubMed, and Cochrane Library to identify adult keloid clinical trials published in English between 2015 and 2025. Two independent reviewers extracted study characteristics, Fitzpatrick skin type quantification, patient image representation, and outcome stratification, with a third reviewer consulted to resolve any disagreements. Reporting practices were summarized with descriptive statistics; associations with study characteristics were evaluated using Wilcoxon rank-sum tests and binary logistic regression. </p> Results <p>Seventy-one eligible trials were identified. 21.1% reported qualitative skin tone descriptors, and 16.9% quantified Fitzpatrick skin type. No study stratified outcomes by Fitzpatrick skin type. Patient images were included in 64.8% of studies, though representation was skewed toward Fitzpatrick type III, with limited depiction of types V and VI. Fitzpatrick quantification was not associated with publication year, cohort size, geographic region, or country income level. Studies with patient images demonstrated higher odds of Fitzpatrick quantification (OR = 7.5), though this was not statistically significant. Fitzpatrick skin type is inconsistently reported and not incorporated into outcome analyses in recent keloid clinical trials. Given the well-established association between keloids and darker skin types, this gap limits the generalizability of findings to the populations most affected.</p> Conclusions <p>Standardizing Fitzpatrick skin type documentation is a necessary step toward ensuring keloid research reflects the patients it most affects. Looking ahead, expanding the scale to capture the full diversity of human skin tone would also mark a meaningful stride toward more inclusive and equitable keloid clinical trials.</p>

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Representation of Fitzpatrick skin type in keloid clinical trials: a systematic review

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2026年8月4日

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  • Abygail Andebrhan,
  • Bronwyn Tollefson,
  • Athena Brooks,
  • Lana Kamel,
  • Martha Barnard,
  • Lauren Powell,
  • Umar Choudry

摘要

Background

Keloids disproportionately affect individuals with darker Fitzpatrick skin types; however, it is unclear whether this is reflected in clinical trial reporting. This systematic review evaluates current reporting practices of Fitzpatrick skin type in adult keloid clinical trials, including documentation of skin tone, quantification of Fitzpatrick skin type, and outcome stratification.

Methods

A systematic review was conducted in accordance with PRISMA guidelines using Ovid MEDLINE, PubMed, and Cochrane Library to identify adult keloid clinical trials published in English between 2015 and 2025. Two independent reviewers extracted study characteristics, Fitzpatrick skin type quantification, patient image representation, and outcome stratification, with a third reviewer consulted to resolve any disagreements. Reporting practices were summarized with descriptive statistics; associations with study characteristics were evaluated using Wilcoxon rank-sum tests and binary logistic regression.

Results

Seventy-one eligible trials were identified. 21.1% reported qualitative skin tone descriptors, and 16.9% quantified Fitzpatrick skin type. No study stratified outcomes by Fitzpatrick skin type. Patient images were included in 64.8% of studies, though representation was skewed toward Fitzpatrick type III, with limited depiction of types V and VI. Fitzpatrick quantification was not associated with publication year, cohort size, geographic region, or country income level. Studies with patient images demonstrated higher odds of Fitzpatrick quantification (OR = 7.5), though this was not statistically significant. Fitzpatrick skin type is inconsistently reported and not incorporated into outcome analyses in recent keloid clinical trials. Given the well-established association between keloids and darker skin types, this gap limits the generalizability of findings to the populations most affected.

Conclusions

Standardizing Fitzpatrick skin type documentation is a necessary step toward ensuring keloid research reflects the patients it most affects. Looking ahead, expanding the scale to capture the full diversity of human skin tone would also mark a meaningful stride toward more inclusive and equitable keloid clinical trials.