Current State of Clinical Trials for Keloid Management: An Analysis of Trials Registered on ClinicalTrials.gov

Background Keloid management remains clinically challenging, and the clinical trial landscape underpinning keloid therapeutics has not been comprehensively characterized. Objective The objective of this study is to characterize the structural features of interventional keloid trials registered on ClinicalTrials.gov, including phase distribution, enrollment size, intervention category, sponsor type, and geographic representation. Methods We conducted a cross-sectional registry analysis of interventional keloid trials listed on ClinicalTrials.gov. Trials with study start dates between January 1, 2005, and December 31, 2024, were identified. Study phase, enrollment size, intervention category, sponsor type, geographic region, trial status, and registry results availability were extracted and descriptively analyzed. For completed trials, PubMed was searched using each trial's National Clinical Trial (NCT) identifier to assess dissemination outside the registry. Results A total of 84 interventional keloid trials met the inclusion criteria. Among the 56 phase-classified trials, early-phase studies (Early Phase 1 through Phase 2) accounted for 62.5%, whereas late-phase studies (Phase 2/3 through Phase 4) accounted for 37.5%. Across all included trials, only six studies (7.1%) were Phase 3, and registry-reported enrollment was below 50 participants in 65 trials (77.4%). Drug-based interventions were the most common category (46.4%), whereas biologic and radiation modalities were rarely represented. Within ClinicalTrials.gov-registered trials, study locations were concentrated in North America and Europe. Regarding temporal distribution, 56 trials (66.7%) were initiated between 2015 and 2024. Of the 84 trials, 52 (61.9%) were classified as completed. Among these, only 10 (19.2%) had results posted on ClinicalTrials.gov, and PubMed searching identified three keloid-specific final results publications, yielding results available through either source for 13 completed trials (25.0%). Conclusion As reflected in ClinicalTrials.gov-registered trials, the current interventional keloid trial landscape is characterized by small studies, early-stage predominance, uneven modality representation, and limited geographic diversity. Limited results accessibility among completed trials further underscores structural gaps in evidence dissemination. These findings highlight the need for larger, more geographically inclusive trials with clearer outcome assessment frameworks and more consistent reporting of results.