CLINICAL TRIAL article
Front. Pharmacol.
Sec. Ethnopharmacology
Volume 16 - 2025 | doi: 10.3389/fphar.2025.1546589
Efficacy and safety of indigo naturalis oil extract (Lindioil ointment) for the treatment of atopic dermatitis: a randomized, crossover, evaluator-blinded, controlled trial
Provisionally accepted
Chin-Yi Yang1
Chun-Bing Chen2
Chun-Wei Lu2Min-Hui Chi2Jennifer Wu2
Wen-Hung Chung2Be-Han Lee2
Yin-Ku Lin3*- 1New Taipei Municipal TuCheng Hospital, New Taipei City, Taiwan
- 2Chang Gung Memorial Hospital, Taipei, Changhua, Taiwan
- 3Keelung Chang Gung Memorial Hospital, Keelung, Taiwan
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Introduction: Lindioil ointment or its compound formulations are commonly used traditional Chinese medicine practitioners to treat adult eczema or localized dermatitis. This study aimed to determine the efficacy and safety of Lindioil ointment (indigo naturalis oil extract) for treating atopic dermatitis (AD).Methods: This was a prospective, randomized, crossover, evaluator-blinded, controlled study.Twenty-two patients with a median age of 26.5 (range, 20.8-44.3) years were treated with Lindioil or tacrolimus 0.1%. The primary outcome was change in the eczema areas severity index (EASI), body surface area (BSA), pruritus numeric rating scale (NRS) and dermatology life quality index (DLQI) after each 6-week treatment.Results: After 6 weeks of treatment, the EASI decreased significantly from 6.6 to 3.4 (P=0.017) in the Lindioil group, and from 6.7 to 1.9 (P<0.001) in the tacrolimus group. The BSA percentage change was significantly less in the tacrolimus group (-43.6% vs. -86.7%, P=0.002).Significant differences between the 2 groups were observed in NRS (-2.5 vs. -5.5, P=0.005) and DLQI median change (-5 vs. -10, P=0.005). After Lindioil or tacrolimus ointment therapy, AD lesions' skin microbiota shifted from Firmicutes dominance to Proteobacteria dominance, resembling non-lesion skin. The proportion of Staphylococcus aureus species in AD lesions significantly decreased after both treatments, and was not different from that of non-lesion skin.Discussion: Lindioil ointment is effective for the treatment of mild-to-severe AD and has less side effects compared to tacrolimus. Lindioil ointment may alleviate AD by altering skin microbiota.The study was registered in ClinicalTrials.gov, under the number NCT03614221.
Keywords: atopic dermatitis, Body surface area (BSA), dermatology life quality index (DLQI) eczema areas severity index (EASI), Indigo naturalis, Lindioil, pruritus numeric rating scale (NRS), Tacrolimus
Received: 17 Dec 2024; Accepted: 27 May 2025.
Copyright: © 2025 Yang, Chen, Lu, Chi, Wu, Chung, Lee and Lin. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Yin-Ku Lin, Keelung Chang Gung Memorial Hospital, Keelung, Taiwan
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