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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