Tags

Type your tag names separated by a space and hit enter

Randomized, double-blind clinical trial of topical imiquimod 5% with parenteral meglumine antimoniate in the treatment of cutaneous leishmaniasis in Peru.
Clin Infect Dis. 2005 May 15; 40(10):1395-403.CI

Abstract

BACKGROUND

Current treatments for cutaneous leishmaniasis are limited by their toxicity, high cost, and discomfort and the emergence of drug resistance. New approaches, including combination therapies, are urgently needed. We performed a double-blind, randomized trial of therapy with parenteral antimony plus topical imiquimod, an innate immune-response modulator, versus therapy with antimony alone, in subjects with cutaneous leishmaniasis for whom an initial course of antimony therapy had failed.

METHODS

Forty subjects with clinical resistance to antimony were recruited in Lima, Peru, between February 2001 and December 2002. All subjects received meglumine antimoniate (20 mg/kg/day im or iv) and were randomized to receive either topical imiquimod 5% cream (Aldara; 3M Pharmaceuticals) or vehicle control every other day for 20 days. Lesions and adverse events were evaluated during treatment and at 1, 2, 3, 6, and 12 months after the treatment period.

RESULTS

The mean number of lesions was 1.2 per person; 71% of the lesions were facial and 76% were ulcerative. There were no major differences between the groups, and all but 2 subjects completed therapy. Mild adverse events were reported by 73% of the subjects, but only erythema occurred more commonly in the imiquimod group (P < or = .02). Lesions resolved more rapidly in the imiquimod group: 50% of the imiquimod group achieved cure at 1 month after the treatment period versus 15% of the vehicle cream group (P < or = .02); 61% of the imiquimod group at 2 months versus 25% of the vehicle cream group (P < or = .03); and 72% of the imiquimod group at 3 months versus 35% of the vehicle cream group (P < or = .02). Residual scarring in the imiquimod group was less prominent than in the vehicle cream group.

CONCLUSIONS

Combined antimony plus imiquimod treatment was well tolerated, accelerated healing of lesions, and improved scar quality. This therapy may have particular advantages for subjects with facial lesions.

Authors+Show Affiliations

Department of Microbiology and Immunology, McGill University, Montreal, Canada.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

15844060

Citation

Miranda-Verástegui, C, et al. "Randomized, Double-blind Clinical Trial of Topical Imiquimod 5% With Parenteral Meglumine Antimoniate in the Treatment of Cutaneous Leishmaniasis in Peru." Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America, vol. 40, no. 10, 2005, pp. 1395-403.
Miranda-Verástegui C, Llanos-Cuentas A, Arévalo I, et al. Randomized, double-blind clinical trial of topical imiquimod 5% with parenteral meglumine antimoniate in the treatment of cutaneous leishmaniasis in Peru. Clin Infect Dis. 2005;40(10):1395-403.
Miranda-Verástegui, C., Llanos-Cuentas, A., Arévalo, I., Ward, B. J., & Matlashewski, G. (2005). Randomized, double-blind clinical trial of topical imiquimod 5% with parenteral meglumine antimoniate in the treatment of cutaneous leishmaniasis in Peru. Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America, 40(10), 1395-403.
Miranda-Verástegui C, et al. Randomized, Double-blind Clinical Trial of Topical Imiquimod 5% With Parenteral Meglumine Antimoniate in the Treatment of Cutaneous Leishmaniasis in Peru. Clin Infect Dis. 2005 May 15;40(10):1395-403. PubMed PMID: 15844060.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Randomized, double-blind clinical trial of topical imiquimod 5% with parenteral meglumine antimoniate in the treatment of cutaneous leishmaniasis in Peru. AU - Miranda-Verástegui,C, AU - Llanos-Cuentas,A, AU - Arévalo,I, AU - Ward,B J, AU - Matlashewski,G, Y1 - 2005/04/07/ PY - 2004/09/10/received PY - 2004/12/10/accepted PY - 2005/4/22/pubmed PY - 2006/6/29/medline PY - 2005/4/22/entrez SP - 1395 EP - 403 JF - Clinical infectious diseases : an official publication of the Infectious Diseases Society of America JO - Clin Infect Dis VL - 40 IS - 10 N2 - BACKGROUND: Current treatments for cutaneous leishmaniasis are limited by their toxicity, high cost, and discomfort and the emergence of drug resistance. New approaches, including combination therapies, are urgently needed. We performed a double-blind, randomized trial of therapy with parenteral antimony plus topical imiquimod, an innate immune-response modulator, versus therapy with antimony alone, in subjects with cutaneous leishmaniasis for whom an initial course of antimony therapy had failed. METHODS: Forty subjects with clinical resistance to antimony were recruited in Lima, Peru, between February 2001 and December 2002. All subjects received meglumine antimoniate (20 mg/kg/day im or iv) and were randomized to receive either topical imiquimod 5% cream (Aldara; 3M Pharmaceuticals) or vehicle control every other day for 20 days. Lesions and adverse events were evaluated during treatment and at 1, 2, 3, 6, and 12 months after the treatment period. RESULTS: The mean number of lesions was 1.2 per person; 71% of the lesions were facial and 76% were ulcerative. There were no major differences between the groups, and all but 2 subjects completed therapy. Mild adverse events were reported by 73% of the subjects, but only erythema occurred more commonly in the imiquimod group (P < or = .02). Lesions resolved more rapidly in the imiquimod group: 50% of the imiquimod group achieved cure at 1 month after the treatment period versus 15% of the vehicle cream group (P < or = .02); 61% of the imiquimod group at 2 months versus 25% of the vehicle cream group (P < or = .03); and 72% of the imiquimod group at 3 months versus 35% of the vehicle cream group (P < or = .02). Residual scarring in the imiquimod group was less prominent than in the vehicle cream group. CONCLUSIONS: Combined antimony plus imiquimod treatment was well tolerated, accelerated healing of lesions, and improved scar quality. This therapy may have particular advantages for subjects with facial lesions. SN - 1537-6591 UR - https://www.unboundmedicine.com/medline/citation/15844060/Randomized_double_blind_clinical_trial_of_topical_imiquimod_5_with_parenteral_meglumine_antimoniate_in_the_treatment_of_cutaneous_leishmaniasis_in_Peru_ L2 - https://academic.oup.com/cid/article-lookup/doi/10.1086/429238 DB - PRIME DP - Unbound Medicine ER -