Pharmacodynamic Effects of Topical Omiganan in Patients With Mild to Moderate Atopic Dermatitis in a Randomized, Placebo‐Controlled, Phase II Trial

Abstract

Omiganan is an indolicidin analog with antimicrobial properties that could be beneficial for patients with atopic dermatitis. In this randomized, double‐blind, placebo‐controlled, phase II trial we explored the efficacy, pharmacodynamics, and safety of topical omiganan once daily in 36 patients with mild to moderate atomic dermatitis. Patients were randomized to apply topical omiganan 1%, omiganan 2.5%, or vehicle gel to one target lesion once daily for 28 consecutive days. Small but significant improvements in local objective SCORing Atopic Dematitis index and morning itch were observed in the omiganan 2.5% group compared with the vehicle gel group (−18.5%; 95% confidence interval, −32.9 to −1.0; P = 0.04; and −8.2; 95% confidence interval, −16.3 to −0.2; P = 0.05, respectively). A shift from lesional to nonlesional skin microbiota was observed in both omiganan treatment groups, in contrast to the vehicle group. Thus, treatment with topical omiganan improved dysbiosis in patients with mild to moderate atopic dermatitis, and small but statistically significant improvements in clinical scores were detected. Our findings warrant further exploration in future clinical trials.

The infectious complications of atopic dermatitis

“… 69 , 70 Directly targeting S aureus is also an active area of investigation. These treatments include natural products with anti– S aureus activity, 71 synthetic antimicrobial peptides, 72 and S aureus lytic agents. 73 There is currently no approved S aureus vaccine.…”

The Influence of Microbiome Dysbiosis and Bacterial Biofilms on Epidermal Barrier Function in Atopic Dermatitis—An Update

“…Dawgul et al showed a significant anti-staphylococcal and anti-biofilm effect of two amphibian AMPs (citropin 1.1 and temporin A) [164]. Furthermore, a phase II trial of omiganan, an indolicidin analog, revealed its potential for improving microbial dysbiosis on AD skin and a small, but significant effect on clinical scores encouraging further research on the implementation of AMPs [165].…”

New treatments in atopic dermatitis

“…Omiganan gel is an AMP with broad-spectrum activity against gram-positive and gram-negative bacteria and fungi. 29 In a 28-day, phase 2, RDBVCT in adults with mild-to-moderate AD, 2.5% omiganan led to significant improvements in SCORAD (SCORing atopic dermatitis), body surface area, morning itch, and dybiosis when compared with the vehicle. No local AEs were reported.…”

“…No local AEs were reported. 29 Given the reduction in microbial diversity with AD flares and the recognized exacerbation of AD by S aureus, topical supplementation with commensal organisms that kill S aureus has been proposed as therapy. 13 Isolation of S hominis with antieS aureus activity, bacterial expansion, and application to lesional skin in adults with AD (targeted microbiome transplant) reduced S aureus within 24 hours of application.…”