Randomized clinical trial comparing removal followed by topical imiquimod versus removal followed by topical methylprednisolone in the treatment of keloids.

Abstract

Purpose: Keloids are unaesthetic benign dermatosis characterized by a disorganized proliferation of collagen. Treatment of keloids constitutes a therapeutic challenge. The aim of this study was to evaluate the efficacy and effectiveness of topical imiquimod associated with surgical excision in the treatment of keloid.

Methods: A randomized, double blind, matching-lesion (self-paired manner) clinical trial. Ten patients with two keloid lesions each in similar anatomical and contralateral areas (paired lesions) had their keloids excised, and the operative site treated with the application of 5% imiquimod cream or 0.1% methylprednisolone aceponate cream (gold standard) for eight weeks.

Results: Eight patients (total = 16 lesions) completed the study. Four of the total eight keloids (50%) in the methylprednisolone group vs. 3/8 keloids (37.5%) in the imiquimod group recurred in the first post-treatment year (p 0.05).

Conclusion: Surgical removal plus application of topical imiquimod was shown as safe, and its efficacy was not statistically inferior for the treatment of keloids as compared to methylprednisolone. Due to the lack of efficacy in most therapeutic modalities, surgical removal plus topical imiquimod could be recommended as an additional first line therapy and especially for recurrent keloids. Studies with larger samples are necessary to evaluatre therapies for keloids.