Related Experiment Video
Updated: Dec 5, 2025
Isolation, Culture, and Characterization of Primary Dermal Fibroblasts from Human Keloid Tissue
Published on: July 28, 2023
Methodological quality of clinical trials of keloid scars
Martha A Morales-Sánchez1, Andrea De Villafranca-Dugelby1, Fermín Jurado-Santa Cruz1
1Unidad de Investigación del Centro Dermatológico Dr. Ladislao de la Pascua, Servicios de Salud Pública de la Ciudad de México, Ciudad de México, México.
Background:
There is heterogeneity in the design of clinical trials (CT) for the treatment of keloid scars that compromises the validity of their results.
Objective:
To assess the methodological quality of the CT published on keloid scars, mainly the outcomes used in them.
Method:
Articles of CT for keloid scars were analyzed, their methodological quality was evaluated following the CONSORT guidelines and the risk of bias based on the Cochrane tool. All the clinical outcomes measured in CT were identified.
Results:
Fifty-two full-text articles were evaluated, of which, only 3.84% of the CT mentioned important changes in the methodology after starting patient recruitment. Fifty-nine percent of the CT were assessed as high risk of performance bias due to mistakes in blinding participants and personnel. The most frequent outcome was the height or thickness of the keloids.
Conclusions:
We recommend that participants with hypertrophic scars should be excluded from keloids' clinical trials, and that the main outcome must be the scar height and flattening. The pain and quality of life of patients should also be measured.
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