Yang Chin-Yi, Chen Chun-Bing, Lu Chun-Wei, Chi Min-Hui, Wu Jennifer, Chung Wen-Hung, Lee Be-Han, Lin Yin-Ku
Department of Dermatology, New Taipei Municipal Tucheng Hospital, New Taipei City, Taiwan.
Department of Dermatology, Drug Hypersensitivity Clinical and Research Center, Chang Gung Memorial Hospital, Keelung, Taiwan.
Front Pharmacol. 2025 Jul 8;16:1546589. doi: 10.3389/fphar.2025.1546589. eCollection 2025.
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).
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.
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 species in AD lesions significantly decreased after both treatments, and was not different from that of non-lesion skin.
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.
硫黄软膏或其复方制剂是中医治疗成人湿疹或局限性皮炎常用的药物。本研究旨在确定硫黄软膏（青黛油提取物）治疗特应性皮炎（AD）的疗效和安全性。
这是一项前瞻性、随机、交叉、评估者盲法、对照研究。22例年龄中位数为26.5岁（范围20.8 - 44.3岁）的患者接受硫黄软膏或0.1%他克莫司治疗。主要结局是每次6周治疗后湿疹面积和严重程度指数（EASI）、体表面积（BSA）、瘙痒数字评定量表（NRS）和皮肤病生活质量指数（DLQI）的变化。
治疗6周后，硫黄软膏组EASI从6.6显著降至3.4（P = 0.017），他克莫司组从6.7降至1.9（P < 0.001）。他克莫司组的BSA百分比变化显著更小（-43.6%对-86.7%，P = 0.002）。两组在NRS（-2.5对-5.5，P = 0.005）和DLQI中位数变化（-5对-10，P = 0.005）方面观察到显著差异。在硫黄软膏或他克莫司软膏治疗后，AD皮损的皮肤微生物群从以厚壁菌门为主转变为以变形菌门为主，类似于非皮损皮肤。两种治疗后AD皮损中物种的比例均显著下降，且与非皮损皮肤无差异。
硫黄软膏对轻至重度AD有效，且与他克莫司相比副作用更少。硫黄软膏可能通过改变皮肤微生物群来缓解AD。
该研究已在ClinicalTrials.gov注册，注册号为NCT03614221。
