Yin-Ku Lin1, Shu-Han Chang2, Chin-Yi Yang3, Lai-Chu See4, Be-Han Lee5, I-Hsin Shih6. 1. Department of Traditional Chinese Medicine, Chang Gung Memorial Hospital, Keelung, 222, Maijin Road, Keelung, 20401, Taiwan; School of Traditional Chinese Medicine, College of Medicine, Chang Gung University, 259, Wenhua 1st Rd, Guishan Dist, Taoyuan, 33302, Taiwan. Electronic address: lin1266@cgmh.org.tw. 2. Department of Traditional Chinese Medicine, Chang Gung Memorial Hospital, Keelung, 222, Maijin Road, Keelung, 20401, Taiwan. Electronic address: B9605005@cgmh.org.tw. 3. Department of Dermatology, Chang Gung Memorial Hospital, Linkou, 5, Fuxing St, Guishan Dist, Taoyuan, 33305, Taiwan. Electronic address: sophiachinyi@cgmh.org.tw. 4. Department of Public Health, And Biostatistics Core Laboratory, Molecular Medicine Research Center, Chang Gung University, 259, Wenhua 1st Rd, Guishan Dist, Taoyuan, 33302, Taiwan; Department of Rheumatology and Allergy and Immunology, Chang Gung Memorial Hospital, Linkou, 5, Fuxing St, Guishan, Dist, Taoyuan, 33305, Taiwan. Electronic address: lichu@mail.cgu.edu.tw. 5. Department of Traditional Chinese Medicine, Chang Gung Memorial Hospital, Keelung, 222, Maijin Road, Keelung, 20401, Taiwan. Electronic address: abbylee@cgmh.org.tw. 6. Department of Dermatology, Chang Gung Memorial Hospital, Taipei, 199, Dunhua N. Rd, Taipei, 10507, Taiwan. Electronic address: ma1606@cgmh.org.tw.
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.
RCT Entities:
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.