Topical Cotton Boll Extract as an Adjunct to Standard Pentavalent Antimonial Therapy in Cutaneous Leishmaniasis Caused by Leishmania tropica: A Randomized Pilot Clinical Trial
-
Mehdi Shafiei_bafti
,
Iraj Sharifi
,
Maryam Taghavi Shirazi
,
Ali Ghobadi
,
Fatemeh Sharifi
,
Fariba Sharififar
,
Nouzar Nakhaee Amroudi
,
Ali Khamesipour
,
Alireza Keyhani
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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14. Mohebali M, Kazemirad E, Hajjaran H, et al. Gene expression analysis of antimony resistance in Leishmania tropica using quantitative real-time PCR focused on genes involved in trypanothione metabolism and drug transport. Arch Dermatol Res. 2019;311(1):9-17.
15. de Vries HJC, Schallig HD. Cutaneous Leishmaniasis: A 2022 Updated Narrative Review into Diagnosis and Management Developments. Am J Clin Dermatol. 2022;23(6):823-40.
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19. Sharifi F, Sharifi I, Keyhani A, et al. Leishmanicidal, cytotoxic and apoptotic effects of Gossypium hirsutum bulb extract and its separated fractions on Leishmania major. J Vector Borne Dis. 2019;56(4):330-8.
20. Sharifi F, Sharififar F, Pournamdari M, et al. Leishmanicidal potentials of Gossypium hirsutum extract and its fractions on Leishmania major in a murine model: parasite burden, gene expression, and histopathological profile. J Med Microbiol. 2021;70(6).
21. Serdar CC, Cihan M, Yücel D, Serdar MA. Sample size, power and effect size revisited: simplified and practical approaches in pre-clinical, clinical and laboratory studies. Biochem Med (Zagreb). 2021;31(1): 010502.
22. Julious SA. Sample size of 12 per group rule of thumb for a pilot study. Pharmaceutical Statistics. 2005;4(4):287-91.
23. Alves LL, Freire ML, Troian IL, Morais-Teixeira Ed, Cota G. Local amphotericin B therapy for Cutaneous Leishmaniasis: A systematic review. PLoS Negl Trop Dis. 2024;18(4):e0012127.
24. Mashayekhi Goyonlo V, Hassan Abadi H, Zandi H, et al. Efficacy of infrared thermotherapy for treatment of cutaneous leishmaniasis: A descriptive study of 39 cases in Mashhad, Iran. Iranian Journal of Dermatology. 2021;24(1):1-5.
25. Mohammadzadeh M, Behnaz F, Golshan Z. Efficacy of glucantime for treatment of cutaneous leishmaniasis in Central Iran. J Infecti Public Health. 2013;6(2):120-4.
26. Firooz A, Khatami A, Khamesipour A, et al. Intralesional injection of 2% zinc sulfate solution in the treatment of acute old world cutaneous leishmaniasis: a randomized, double-blind, controlled clinical trial. J Drugs Dermatol. 2005;4(1):73-9.
27. Maleki M, Karimi G, Tafaghodi M, Raftari S, Nahidi Y. Comparison of intralesional two percent zinc sulfate and glucantime injection in treatment of acute cutaneous leishmaniasis. Indian J Dermatol. 2012;57(2):118-22.
28. Meeting WECotCotL, Organization WH. Control of the leishmaniases: report of a meeting of the WHO Expert Committee on the Control of Leishmaniases, Geneva, 22-26 March 2010: World Health Organization; 2010.
29. Linquest LA, Hickham LC, Richardson BJ, Hickham PR, Hickham L, Richardson B. Successful treatment of cutaneous leishmaniasis with cryotherapy. Cureus. 2023;15(7): e41871.
2. team WE. Leishmaniasis geneva: World health organization; 2022 [Available from: https://www.who.int/news-room/fact-sheets/detail/leishmaniasis]
3. Steverding D. The history of leishmaniasis. Parasi Vectors. 2017;10(1):82.
4. Mathison BA, Bradley BT. Review of the clinical presentation, pathology, diagnosis, and treatment of leishmaniasis. Lab Med. 2023;54(4):363-71.
5. Ruiz-Postigo JA, Jain S, Madjou S, Agua JFV, et al. Global leishmaniasis surveillance, 2022: assessing trends over the past 10 years/Surveillance mondiale de la leishmaniose, 2022: evaluation des tendances des 10 dernieres annees. Weekly Epidemiological Record. 2023;98(40):471-87.
6. Murshidi MM, Hijjawi MQ, Jeriesat S, Eltom A. Syrian refugees and Jordan's health sector. Lancet. 2013;382(9888):206-7.
7. Alawieh A, Musharrafieh U, Jaber A, et al. Revisiting leishmaniasis in the time of war: the Syrian conflict and the Lebanese outbreak. Int J Infect Dis. 2014;29:115-9.
8. Inci R, Ozturk P, Mulayim MK, et al. Effect of the Syrian Civil War on Prevalence of Cutaneous Leishmaniasis in Southeastern Anatolia, Turkey. Med Sci Monit. 2015;21:2100-4.
9. Du R, Hotez PJ, Al-Salem WS, Acosta-Serrano A. Old World Cutaneous Leishmaniasis and Refugee Crises in the Middle East and North Africa. PLoS Negl Trop Dis. 2016;10(5):e0004545.
10. Annajar B, Buffet P, Morizot G, et al. Manual for case management of cutaneous leishmaniasis in the WHO Eastern Mediterranean Region2014.
11. Vanessa Ngan SW. leishmaniasis UK2017 [Available from: https://dermnetnz.org/topics/leishmaniasis]
12. Hadighi R, Mohebali M, Boucher P, et al. Unresponsiveness to Glucantime treatment in Iranian cutaneous leishmaniasis due to drug-resistant Leishmania tropica parasites. PLoS Med. 2006;3(5):e162.
13. Kazemi-Rad E, Mohebali M, Khadem-Erfan MB, et al. Identification of antimony resistance markers in Leishmania tropica field isolates through a cDNA-AFLP approach. Exp Parasitol. 2013;135(2):344-9.
14. Mohebali M, Kazemirad E, Hajjaran H, et al. Gene expression analysis of antimony resistance in Leishmania tropica using quantitative real-time PCR focused on genes involved in trypanothione metabolism and drug transport. Arch Dermatol Res. 2019;311(1):9-17.
15. de Vries HJC, Schallig HD. Cutaneous Leishmaniasis: A 2022 Updated Narrative Review into Diagnosis and Management Developments. Am J Clin Dermatol. 2022;23(6):823-40.
16. Shahrajabian MH, Sun W, Cheng Q. Considering white gold, cotton, for its fiber, seed oil, traditional and modern health benefits. J Biol Environ Sci. 2020;14(40):25-39.
17. Egbuta MA, McIntosh S, Waters DL, et al. Biological Importance of Cotton By-Products Relative to Chemical Constituents of the Cotton Plant. Molecules. 2017;22(1):93.
18. Chaturvedi A, Nag T. Medicinal value of cotton. International Journal of MediPharm Research. 2015;1:147-9.
19. Sharifi F, Sharifi I, Keyhani A, et al. Leishmanicidal, cytotoxic and apoptotic effects of Gossypium hirsutum bulb extract and its separated fractions on Leishmania major. J Vector Borne Dis. 2019;56(4):330-8.
20. Sharifi F, Sharififar F, Pournamdari M, et al. Leishmanicidal potentials of Gossypium hirsutum extract and its fractions on Leishmania major in a murine model: parasite burden, gene expression, and histopathological profile. J Med Microbiol. 2021;70(6).
21. Serdar CC, Cihan M, Yücel D, Serdar MA. Sample size, power and effect size revisited: simplified and practical approaches in pre-clinical, clinical and laboratory studies. Biochem Med (Zagreb). 2021;31(1): 010502.
22. Julious SA. Sample size of 12 per group rule of thumb for a pilot study. Pharmaceutical Statistics. 2005;4(4):287-91.
23. Alves LL, Freire ML, Troian IL, Morais-Teixeira Ed, Cota G. Local amphotericin B therapy for Cutaneous Leishmaniasis: A systematic review. PLoS Negl Trop Dis. 2024;18(4):e0012127.
24. Mashayekhi Goyonlo V, Hassan Abadi H, Zandi H, et al. Efficacy of infrared thermotherapy for treatment of cutaneous leishmaniasis: A descriptive study of 39 cases in Mashhad, Iran. Iranian Journal of Dermatology. 2021;24(1):1-5.
25. Mohammadzadeh M, Behnaz F, Golshan Z. Efficacy of glucantime for treatment of cutaneous leishmaniasis in Central Iran. J Infecti Public Health. 2013;6(2):120-4.
26. Firooz A, Khatami A, Khamesipour A, et al. Intralesional injection of 2% zinc sulfate solution in the treatment of acute old world cutaneous leishmaniasis: a randomized, double-blind, controlled clinical trial. J Drugs Dermatol. 2005;4(1):73-9.
27. Maleki M, Karimi G, Tafaghodi M, Raftari S, Nahidi Y. Comparison of intralesional two percent zinc sulfate and glucantime injection in treatment of acute cutaneous leishmaniasis. Indian J Dermatol. 2012;57(2):118-22.
28. Meeting WECotCotL, Organization WH. Control of the leishmaniases: report of a meeting of the WHO Expert Committee on the Control of Leishmaniases, Geneva, 22-26 March 2010: World Health Organization; 2010.
29. Linquest LA, Hickham LC, Richardson BJ, Hickham PR, Hickham L, Richardson B. Successful treatment of cutaneous leishmaniasis with cryotherapy. Cureus. 2023;15(7): e41871.
| Files | ||
| Issue | Vol 21 No 3 (2026) | |
| Section | Original Article(s) | |
| Keywords | ||
| Cutaneous leishmaniasis Cotton boll Persian medicine Herbal remedy | ||
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How to Cite
1.
Shafiei_bafti M, Sharifi I, Taghavi Shirazi M, Ghobadi A, Sharifi F, Sharififar F, Nakhaee Amroudi N, Khamesipour A, Keyhani A. Topical Cotton Boll Extract as an Adjunct to Standard Pentavalent Antimonial Therapy in Cutaneous Leishmaniasis Caused by Leishmania tropica: A Randomized Pilot Clinical Trial. Iran J Parasitol. 2026;21(3):348-358.
