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

J Ethnopharmacol. 2020 Mar 25;250:112477. doi: 10.1016/j.jep.2019.112477. Epub 2019 Dec 12.

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. ClinicalTrials.gov identifier: NCT02669888.

Keywords: Atopic dermatitis; EASI; Indigo naturalis; Indirubin.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Administration, Cutaneous
  • Adolescent
  • Adult
  • Aged
  • Child
  • Dermatitis, Atopic / drug therapy*
  • Dermatitis, Atopic / pathology
  • Dermatologic Agents / administration & dosage*
  • Dermatologic Agents / adverse effects
  • Double-Blind Method
  • Drugs, Chinese Herbal / administration & dosage*
  • Drugs, Chinese Herbal / adverse effects
  • Female
  • Humans
  • Male
  • Middle Aged
  • Severity of Illness Index
  • Treatment Outcome
  • Young Adult

Substances

  • Dermatologic Agents
  • Drugs, Chinese Herbal
  • Qingdai compound

Associated data

  • ClinicalTrials.gov/NCT02669888