Topical Cotton Boll Extract As an Adjunct to Standard Pentavalent Antimonial Therapy in Cutaneous Leishmaniasis Caused by Leishmania Tropica: A Randomized Pilot Clinical Trial



Bafti M S ; Sharifi I ; Shirazi M T ; Ghobadi A ; Sharifi F ; Sharififar F ; Amroudi N N ; Khamesipour A ; Keyhani A
Source: Iranian Journal of Parasitology Published:2026

Abstract

Background: Cutaneous leishmaniasis (CL) is a widespread disease with a serious global public health concern. Although pentavalent antimonial (MAT) drugs remain the standard treatment, their painful administration, incomplete responses, and poor patient adherence highlight the need for alternative or adjunctive therapies. Herbal and Traditional medicines are increasingly investigated as affordable and accessible options. This research aimed to assess how well a topical herbal treatment made from cotton boll extract worked and how safe. Methods: This randomized, open-label clinical study evaluated the efficacy of a topical herbal formulation derived from cotton boll extract as an adjunct to MAT therapy. This study was conducted in 2025 at the CL Treatment Center in Kerman and included 58 patients with PCR-confirmed Leishmania tropica infection. Volunteer participants were randomly assigned to receive either intralesional MAT plus topical cotton boll extract or MAT combined with cryotherapy. Outcomes included time to lesion healing, changes in lesion size and induration. Results: Results showed a reduction in lesion diameter and induration in both groups throughout the follow-up assessments. By week 12, complete lesion healing was detected in 95.2% of cases in the experimental group and 83.3% in the control arm; there was no meaningful difference between treatments. No significant adverse effects were observed. Conclusion: Topical cotton boll extract can be considered as a non-invasive adjunctive therapy in the management of CL. © 2026. Shafiei Bafti et al.