Comparison between the Efficacy of Photodynamic Therapy and Topical Paromomycin in the Treatment of Old World Cutaneous Leishmaniasis: A Placebo-controlled, Randomized Clinical Trial

Document Type : Original Article(s)

Authors

1 Professor, Skin Disease and Cutaneous Leishmaniasis Research Center And Department of Dermatology, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran

2 Resident, Skin and Stem Cell Research Center, Tehran University of Medical Sciences, Tehran And Department of Dermatology, School of Medicine And Student Research Committee, Isfahan University of Medical Sciences, Isfahan, Iran

Abstract

Background: The optimal treatment for cutaneous leishmaniasis (CL) has not been established. Topical paromomycin is one of the many drugs that have been suggested for the treatment of CL caused by leishmania major. Recently, photodynamic therapy (PDT) has been reported to be effective in the treatment of CL. The aim of the present study was to compare the parasitological and clinical efficacy of PDT versus topical paromomycin in patients with old world CL caused by leishmania major in Iran.Methods: In this trial, 60 patients with the clinical and parasitological diagnosis of CL were recruited and were randomly divided in to three treatment groups of 20 subjects each. Group 1 was treated with weekly topical PDT, and groups 2 and 3 received twice-daily topical paromomycin and placebo, respectively. The duration of treatment was 4 weeks for all groups. These groups were followed for 2 months after termination of treatment.Findings: In total, 57 patients with 95 lesions completed the study. At the end of thestudy, complete improvement was seen in 29 out of 31 (93.5%), 14 out of 34 (41.2%) and 4 out of 30 lesions (13.3%) in groups 1, 2 and 3, respectively (P < 0.001). At the same timepoint, 100%, 64.7%, and 20% of the lesions had parasitological cure in groups 1, 2 and 3, respectively (P < 0.001). Conclusion: Topical PDT can be used safely as a rapid and highly effective alternative treatment choice for old world CL in selected patients.

Keywords


  1. Azmoudeh M. Report on Leishmaniasis in Iran. Tehran, Iran: Ministry of Health, Treatment and Medication Education; 1990.
  2. Dowlati Y. Cutaneous leishmaniasis: clinical aspect. Clin Dermatol 1996; 14(5): 425-31.
  3. UNDP WBW. Tropical disease research: progress 1995-96 Thirteenth Programme Report of the UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases. Geneva: WHO; 1997.
  4. Enk CD, Fritsch C, Jonas F, Nasereddin A, Ingber A, Jaffe CL, et al. Treatment of Cutaneous Leishmaniasis With Photodynamic Therapy. Arch Dermatol 2003; 139(4): 432-4.
  5. Gardlo K, Horska Z, Enk CD, Rauch L, Megahed M, Ruzicka T, et al. Treatment of cutaneous leishmaniasis by photodynamic therapy. J Am Acad Dermatol 2003; 48(6): 893-6.
  6. Gardlo K, Hanneken S, Ruzicka T, Neumann NJ. Photodynamic therapy of cutaneous leishmaniasis. A promising new therapeutic modality. Hautarzt 2004; 55(4): 381-3. [In German].
  7. Iraji F, Sadeghinia A. Efficacy of paromomycin ointment in the treatment of cutaneous leishmaniasis: results of a double-blind, randomized trial in Isfahan, Iran. Ann Trop Med Parasitol 2005; 99(1): 3-9.
  8. El-On J, Halevy S, Grunwald MH, Weinrauch L. Topical treatment of Old World cutaneous leishmaniasis caused by Leishmania major: a double-blind control study. J Am Acad Dermatol 1992; 27(2 Pt 1): 227-31.
  9. Ibbotson SH. Topical 5-aminolaevulinic acid photodynamic therapy for the treatment of skin conditions other than non-melanoma skin cancer. Br J Dermatol 2002; 146(2): 178-88.
  10. Abok K, Cadenas E, Brunk U. An experimental model system for leishmaniasis. Effects of porphyrin-compounds and menadione on Leishmania parasites engulfed by cultured macrophages. APMIS 1988; 96(6): 543-51.
  11. Stojiljkovic I, Evavold BD, Kumar V. Antimicrobial properties of porphyrins. Expert Opin Investig Drugs 2001; 10(2): 309-20.
  12. Stender IM, Lock-Andersen J, Wulf HC. Recalcitrant hand and foot warts successfully treated with photodynamic therapy with topical 5-aminolaevulinic acid: a pilot study. Clin Exp Dermatol 1999; 24(3): 154-9.
  13. Calzavara-Pinton PG, Venturini M, Sala R. A comprehensive overview of photodynamic therapy in the treatment of superficial fungal infections of the skin. J Photochem Photobiol B 2005; 78(1): 1-6.