Intralesional Cryotherapy Versus Excision with Corticosteroids or Brachytherapy for Keloid Treatment: Preliminary Results of a Randomised Controlled Trial

Background: Keloids are a burden for patients due to physical, aesthetic and social complaints. Treatment remains a challenge because of therapy resistance and high recurrence rates. The main goal of treatment is to improve the quality of life (QoL); this implies that, apart from surgical outcomes, patient-reported outcome measures (PROMs) need to be taken into account. Decision-making in keloid treatment is difficult due to heterogeneity of the condition and the lack of comparative studies.  

Methods: This is a multicentre randomized controlled open trial that compares intralesional cryotherapy versus excision with corticosteroids or brachytherapy. The primary outcome is the POSAS, a 12-item scar assessment scale. Secondary outcomes are recurrence rates, volume reduction, Skindex-29 scores, SF-36 scores and complication rates.¹ During the study we added an outcome measure ‘patient satisfaction’ defined as patients not seeking further medical treatment for their keloid.

Results: There were 179 keloid patients with surgical indication seen during the inclusion period. Seventy-four of them were eligible by our inclusion criteria, unfortunately only 26 gave informed consent for randomization. By October 2015 follow-up will be completed. Due to the small patient group statistical analysis of our outcome measures will not be possible. We did see much lower patient satisfaction with cryotherapy than with excision and additional treatment. Also, our results were less favorable than previously reported on intralesional cryotherapy.^2,3 Most patients undergoing cryotherapy asked for excision with additional brachytherapy afterwards.

Discussion: Intralesional cryotherapy is not as favorable as previously reported, at least not for all keloid patients. The previous studies (case series) probably selected patients with keloids well suitable for intralesional cryotherapy. Besides, in this randomized trial patients were eligible and informed about other treatment options, which might have influenced their search for further treatment. For future research on keloid treatment we advise to look for other study designs in order to improve inclusion and generalizability of the results.