ORIGINAL RESEARCH article
Front. Pharmacol.
Sec. Ethnopharmacology
Volume 16 - 2025 | doi: 10.3389/fphar.2025.1595019
Efficacy of Indigo Naturalis nanofibrous patches in the treatment of chronic plaque psoriasis: a 4-week prospective, randomized, semi-compartmental paired, positive drug-controlled trial
Provisionally accepted
- Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, China
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Background: Indigo Naturalis (IN) has been traditionally used for psoriasis treatment. We developed an IN-poly( ε -caprolactone, PCL)/poly(ethylene oxide, PEO) nanofibrous patch using electrospinning technology. Preliminary studies demonstrated its potential to reduces keratinocyte proliferation, inflammation, and neovascularization, addressing limitations of conventional IN formulations such as poor absorption and skin staining. Aims: To evaluate the safety and efficacy of the IN-PCL/PEO patch for chronic plaque psoriasis. Methods: The clinical trial included 36 patients diagnosed with chronic plaque psoriasis. Two symmetrical psoriatic lesions from each eligible patient were selected by dermatologists and randomly assigned to receive either calcipotriol ointment (control group) or IN-PCL/PEO nanofibrous patch (test group) for 4 weeks. Primary outcomes included Psoriasis Area and Severity Index (PASI), while secondary outcomes assessed Patient Global Assessment (PGA), skin irritation, and patient satisfaction. Safety was monitored via blood, urine, and liver/kidney function tests. Results: 30 subjects completed the treatment trial with both IN and CA. In the test group (n = 30), PASI scores decreased from 6.30 ± 2.23 to 2.13 ± 1.57 (p < 0.001). Within this group, 90.0% (27/30) achieved PASI 50 and 43.3% (13/30) achieved PASI 75. No skin irritation cases were reported (0.0%). While PASI scores decreased from 6.23 ± 2.27 to 2.23 ± 1.50 (p < 0.001) in the control group, 86.7% (26/30) achieved PASI 50 and 33.3% (10/30) achieved PASI 75, with 6.7% (2/30) experiencing irritation. All safety parameters remained within standard reference ranges. Conclusions: The IN-PCL/PEO patch demonstrated efficacy comparable to calcipotriol ointment, with improved safety and tolerability, suggesting its potential as an alternative psoriasis treatment.
Keywords: Psoriasis, Indigo naturalis, Clinical Trial, nanofibrous patch, Calcipotriol
Received: 17 Mar 2025; Accepted: 22 May 2025.
Copyright: © 2025 Zhao, Li, Zhang, Liu, Pengyu, LI, Xu and Song. 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: Ping Song, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, China
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