A randomised clinical trial study assessing the efficacy of 5% losartan potassium loaded in ethosomal gel based on POSAS 3.0 score, degree of erythema and pigmentation, surface area, thickness and pliability of human keloids: a study protocol

Abstract

Background: Keloid is a skin disorder that results from excessive fibrous tissue growth in the area of the initial trauma. Treating keloids can be challenging since the success of various treatments varies from one study to another. Triamcinolone acetonide injection, a standard treatment, can cause undesirable side effects. Meanwhile, the effectiveness of existing topical therapies for keloids is not always reliable. The pro-inflammatory, pro-proliferative, and pro-fibrotic effects of angiotensin II in human skin contribute to keloid formation. Losartan potassium, an angiotensin II blocker, has the potential to act as an anti-keloid agent. Due to the thicker skin structure of a keloid and ease of application, ethosome gel is chosen as a safe and comfortable carrier for losartan potassium, making it a good choice for treating keloids. Methods: In this randomised clinical trial, 46 adults with keloids were divided into two treatment groups. One group of 23 participants received 5% losartan potassium loaded in ethosomal gel, while the other group of 23 participants received intralesional injections of 10% triamcinolone acetonide. Over 12 weeks, changes in POSAS 3.0 scores, erythema and pigmentation, surface area, thickness, and pliability of the keloids will be measured at four different times: baseline, four weeks, eight weeks, and twelve weeks. Statistical analysis will be conducted using SPSS software version 24, with a significance level of p<0.05. Discussion: Losartan potassium is believed to be beneficial for keloid management because it inhibits the angiotensin II receptor, which plays a role in inflammation, proliferation, and fibrosis. This study aims to examine the efficacy of 5% losartan potassium loaded in ethosomal gel for human keloids. Trial registration: Clinicaltrial.gov identifier NCT05893108. Registered on 7 June 2023.