瘢痕疙瘩管理临床试验的现状：ClinicalTrials.gov上注册的试验分析

摘要(中文译文)

背景 瘢痕疙瘩的管理在临床上仍具有挑战性，而支撑瘢痕疙瘩治疗方法的临床试验整体格局尚未得到全面描述。目的 本研究旨在描述在ClinicalTrials.gov注册的瘢痕疙瘩干预性试验的结构特征，包括分期分布、入组规模、干预类别、申办方类型和地域代表性。方法 我们对ClinicalTrials.gov上列出的瘢痕疙瘩干预性试验进行了横断面注册库分析。纳入研究开始日期在2005年1月1日至2024年12月31日之间的试验。提取研究分期、入组规模、干预类别、申办方类型、地理区域、试验状态和注册库结果可及性，并进行描述性分析。对于已完成的试验，使用每项试验的国家临床试验（NCT）标识符在PubMed中检索，以评估注册库之外的成果传播情况。结果 共有84项瘢痕疙瘩干预性试验符合纳入标准。在56项已分期的试验中，早期研究（早期1期至2期）占62.5%，而晚期研究（2/3期至4期）占37.5%。在所有纳入试验中，仅6项研究（7.1%）为3期，65项试验（77.4%）的注册库报告入组人数低于50名受试者。药物类干预是最常见的类别（46.4%），而生物制剂和放射治疗方式很少出现。在ClinicalTrials.gov注册的试验中，研究地点集中在北美和欧洲。在时间分布方面，56项试验（66.7%）于2015年至2024年间启动。在84项试验中，52项（61.9%）被归类为已完成。其中，仅10项（19.2%）在ClinicalTrials.gov上发布了结果，PubMed检索识别出3篇瘢痕疙瘩特异性最终结果发表，使得13项已完成试验（25.0%）可通过任一来源获取结果。结论 如ClinicalTrials.gov注册试验所反映，当前瘢痕疙瘩干预性试验格局的特征为小型研究为主、早期阶段占主导、干预方式代表性不均衡以及地理多样性有限。已完成试验中结果可及性有限进一步凸显了证据传播方面的结构性缺口。这些发现强调需要更大规模、地域包容性更强、具有更清晰结局评估框架且结果报告更一致的试验。

Abstract

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.

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