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Imiquimod in combination with meglumine antimoniate for cutaneous leishmaniasis: a randomized assessor-blind controlled trial.
Arch Dermatol. 2006 Dec; 142(12):1575-9.AD

Abstract

OBJECTIVE

To determine the efficacy and safety of imiquimod in combination with meglumine antimoniate in treating cutaneous leishmaniasis.

DESIGN

Prospective, randomized, assessor-blind, parallel-design, placebo-controlled trial.

SETTING

Two primary care health clinics.

PATIENTS

One hundred nineteen patients (59 patients in the imiquimod group and 60 in the placebo group) were included in the study.

INTERVENTIONS

Patients were randomly assigned to receive a combined 4-week course of imiquimod or placebo with meglumine antimoniate treatment (20 mg/kg of pentavalent antimony daily for 2 weeks) in an endemic area of Leishmania tropica.

MAIN OUTCOME MEASURES

The primary end point was clinical cure, defined as more than 75% reduction in the size of lesions compared with baseline at week 8.

RESULTS

At the end of the 4-week treatment period, clinical cure was similar in both groups (11 patients [18.6%] in the imiquimod-treated group vs 18 patients [30.0%] in the placebo group) (P = .15). Four weeks after the end of treatment, 26 patients (44.1%) and 29 patients (48.3%) in the imiquimod-treated and placebo groups, respectively, were cured (P = .64). Pruritus and burning sensation were reported by 3 patients treated with imiquimod and by no patients treated with placebo.

CONCLUSION

This study showed no beneficial effect of combining a 4-week course of treatment with 5% imiquimod cream and a standard course of treatment with meglumine antimoniate in patients with cutaneous leishmaniasis in an endemic area of L tropica.

TRIAL REGISTRATION

isrctn.org Identifier:ISRCTN77659407 and Cochrane Skin Group Identifier: CSG Trial No. 32.

Links

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Authors+Show Affiliations

Firooz A
Center for Research and Training in Skin Diseases and Leprosy, Tehran University of Medical Sciences, Iran. firozali@sina.tums.ac.ir
Khamesipour A
No affiliation info available
Ghoorchi MH
No affiliation info available
Nassiri-Kashani M
No affiliation info available
Eskandari SE
No affiliation info available
Khatami A
No affiliation info available
Hooshmand B
No affiliation info available
Gorouhi F
No affiliation info available
Rashighi-Firoozabadi M
No affiliation info available
Dowlati Y
No affiliation info available

MeSH

Adjuvants, ImmunologicAdolescentAdultAminoquinolinesAnimalsAntimonyAntiprotozoal AgentsChildDrug Therapy, CombinationFemaleFollow-Up StudiesHumansImiquimodLeishmania tropicaLeishmaniasis, CutaneousMaleMeglumineMeglumine AntimoniateMiddle AgedOrganometallic CompoundsProspective StudiesSingle-Blind MethodTreatment Outcome

Pub Type(s)

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

Language

eng

PubMed ID

17178983

Citation

Firooz, Alireza, et al. "Imiquimod in Combination With Meglumine Antimoniate for Cutaneous Leishmaniasis: a Randomized Assessor-blind Controlled Trial." Archives of Dermatology, vol. 142, no. 12, 2006, pp. 1575-9.
Firooz A, Khamesipour A, Ghoorchi MH, et al. Imiquimod in combination with meglumine antimoniate for cutaneous leishmaniasis: a randomized assessor-blind controlled trial. Arch Dermatol. 2006;142(12):1575-9.
Firooz, A., Khamesipour, A., Ghoorchi, M. H., Nassiri-Kashani, M., Eskandari, S. E., Khatami, A., Hooshmand, B., Gorouhi, F., Rashighi-Firoozabadi, M., & Dowlati, Y. (2006). Imiquimod in combination with meglumine antimoniate for cutaneous leishmaniasis: a randomized assessor-blind controlled trial. Archives of Dermatology, 142(12), 1575-9.
Firooz A, et al. Imiquimod in Combination With Meglumine Antimoniate for Cutaneous Leishmaniasis: a Randomized Assessor-blind Controlled Trial. Arch Dermatol. 2006;142(12):1575-9. PubMed PMID: 17178983.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Imiquimod in combination with meglumine antimoniate for cutaneous leishmaniasis: a randomized assessor-blind controlled trial. AU - Firooz,Alireza, AU - Khamesipour,Ali, AU - Ghoorchi,Mohammad H, AU - Nassiri-Kashani,Mansour, AU - Eskandari,S Ebrahim, AU - Khatami,Alireza, AU - Hooshmand,Badakhshan, AU - Gorouhi,Farzam, AU - Rashighi-Firoozabadi,Mehdi, AU - Dowlati,Yahya, PY - 2006/12/21/pubmed PY - 2007/1/26/medline PY - 2006/12/21/entrez SP - 1575 EP - 9 JF - Archives of dermatology JO - Arch Dermatol VL - 142 IS - 12 N2 - OBJECTIVE: To determine the efficacy and safety of imiquimod in combination with meglumine antimoniate in treating cutaneous leishmaniasis. DESIGN: Prospective, randomized, assessor-blind, parallel-design, placebo-controlled trial. SETTING: Two primary care health clinics. PATIENTS: One hundred nineteen patients (59 patients in the imiquimod group and 60 in the placebo group) were included in the study. INTERVENTIONS: Patients were randomly assigned to receive a combined 4-week course of imiquimod or placebo with meglumine antimoniate treatment (20 mg/kg of pentavalent antimony daily for 2 weeks) in an endemic area of Leishmania tropica. MAIN OUTCOME MEASURES: The primary end point was clinical cure, defined as more than 75% reduction in the size of lesions compared with baseline at week 8. RESULTS: At the end of the 4-week treatment period, clinical cure was similar in both groups (11 patients [18.6%] in the imiquimod-treated group vs 18 patients [30.0%] in the placebo group) (P = .15). Four weeks after the end of treatment, 26 patients (44.1%) and 29 patients (48.3%) in the imiquimod-treated and placebo groups, respectively, were cured (P = .64). Pruritus and burning sensation were reported by 3 patients treated with imiquimod and by no patients treated with placebo. CONCLUSION: This study showed no beneficial effect of combining a 4-week course of treatment with 5% imiquimod cream and a standard course of treatment with meglumine antimoniate in patients with cutaneous leishmaniasis in an endemic area of L tropica. TRIAL REGISTRATION: isrctn.org Identifier:ISRCTN77659407 and Cochrane Skin Group Identifier: CSG Trial No. 32. SN - 0003-987X UR - https://www.unboundmedicine.com/medline/citation/17178983/Imiquimod_in_combination_with_meglumine_antimoniate_for_cutaneous_leishmaniasis:_a_randomized_assessor_blind_controlled_trial_ L2 - https://jamanetwork.com/journals/jamadermatology/fullarticle/10.1001/archderm.142.12.1575 DB - PRIME DP - Unbound Medicine ER -