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Peer-reviewedCC BY-NCIranian journal of parasitology

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

8 affiliations
  1. 1Department of Traditional Medicine, School of Persian Medicine, Iran University of Medical Sciences, Tehran, Iran.
  2. 2Student Research Committee, Iran University of Medical Sciences, Tehran, Iran.
  3. 3Leishmaniasis Research Center, Kerman University of Medical Sciences, Kerman, Iran.
  4. 4Institute for Studies in Medical History, Persian and Complementary Medicine, Iran University of Medical Sciences, Tehran, Iran.
  5. 5Research Center of Tropical and Infectious Diseases, Kerman University of Medical Sciences, Kerman, Iran.
  6. 6Herbal and Traditional Medicines Research Center, Kerman University of Medical Sciences, Kerman, Iran.
  7. 7Health Services Management Research Center, Kerman University of Medical Sciences, Kerman, Iran.
  8. 8Center for Research and Training in Skin Disease and Leprosy, Tehran University of Medical Sciences, Tehran, Iran.

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.

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BibTeX
@article{bafti2026topical,
  title = {{Topical Cotton Boll Extract as an Adjunct to Standard Pentavalent Antimonial Therapy in Cutaneous Leishmaniasis Caused by Leishmania tropica: A Randomized Pilot Clinical Trial.}},
  author = {Mehdi Shafiei Bafti and Iraj Sharifi and Maryam Taghavi Shirazi and Ali Ghobadi and Fatemeh Sharifi and Fariba Sharififar and Nouzar Nakhaee Amroudi and Ali Khamesipour and Alireza Keyhani},
  journal = {Iranian journal of parasitology},
  year = {2026},
  month = jul,
  doi = {10.18502/ijpa.v21i3.22591},
  url = {https://europepmc.org/article/MED/42974457},
  note = {CC BY-NC},
}
RIS
TY  - JOUR
TI  - Topical Cotton Boll Extract as an Adjunct to Standard Pentavalent Antimonial Therapy in Cutaneous Leishmaniasis Caused by Leishmania tropica: A Randomized Pilot Clinical Trial.
AU  - Mehdi Shafiei Bafti
AU  - Iraj Sharifi
AU  - Maryam Taghavi Shirazi
AU  - Ali Ghobadi
AU  - Fatemeh Sharifi
AU  - Fariba Sharififar
AU  - Nouzar Nakhaee Amroudi
AU  - Ali Khamesipour
AU  - Alireza Keyhani
PY  - 2026
DA  - 2026/07/01
JO  - Iranian journal of parasitology
DO  - 10.18502/ijpa.v21i3.22591
UR  - https://europepmc.org/article/MED/42974457
AB  - 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.
SN  - 1735-7020
SN  - 2008-238X
ER  -