Efficacy and safety of indigo naturalis ointment in Treating Atopic Dermatitis: A randomized clinical trial

Authors Lin, Yin-Ku; Chang, Shu-Han; Yang, Chin-Yi; See, Lai -Chu; Lee, Be-Han; Shih, I-Hsin

Journal JOURNAL OF ETHNOPHARMACOLOGY , MAR 25 2020,:250

DOI 10.1016/j.jep.2019.112477 PubMed 31838180

Abstract Ethnopharmacological relevance: Indigo naturalis, a herbal medicine with a history of use dating back to ancient times, may be a good alternative topical treatment for atopic dermatitis (AD).Aim of the study: To provide empirical evidence of the efficacy and safety of Indigo naturalis ointment in treating AD.Materials and methods: In this randomized double-blind clinical trial, participants aged 6 to 65 years with AD affecting less than 40% of their body surface area (BSA) and an Investigator''s Global Assessment (IGA) score of 2 to 4 were randomized (2:1) to receive either Lindioil ointment or a vehicle ointment twice daily for 6 weeks. The primary endpoint was the percentage change in the Eczema Area Severity Index (EASI) from baseline to week 6. Secondary endpoints were as follows: EASI improvement 50%, 75%, and 90%; IGA score; BSA affected by AD; pruritus severity; and Dermatology Life Quality Index. The safety assessment included adverse events (AEs), laboratory tests, and physical examinations.Results: The Lindioil group (32 participants) and vehicle group (16 participants) achieved mean percentage EASI reductions of 49.9% +/- 36.5% (95% CI 36.8%-63.1%) and 19.6% +/- 52.2% (95% CI -8.2%-47.4%), respectively (P = 0.0235). The Lindioil group also showed greater improvement in every secondary assessment category. No significant AEs occurred.Conclusion: Indigo naturalis ointment is effective for treating mild to severe AD topically, and appears to be safe. This is the first clinical trial to provide evidence supporting topical indigo-based AD treatment.