drugset / Trial / NCT01300975
Intralesional Antimony for Bolivian Cutaneous Leishmaniasis
Phase 2
Completed
90 enrolled
Fundacion Nacional de Dermatologia
Hospital Dermatológico de Jorochito · collabProyecto OSCAR · collabThe Alfred Berman Foundation for Medical Research · collabUniversidad Mayor de San Simón · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
Intralesional injection of antimony has been used for L major from Iran with a modest cure rate \[56%: Asilian 2004\]. However, this therapeutic approach has been used for L braziliensis from Brazil, with an attractive cure rate after 3 months of 80% \[Oliveira-Neto 1997\]. Because intralesional Sb injections is the local therapy with the best reported cure rate for South American L braziliensis disease, the species that causes disease in Bolivia, this pilot study of local therapy for bolivian L braziliensis disease will evaluate intralesional Sb therapy.
Timeline
- Start
- 2011-01
- Primary completion
- 2012-07
- Completion
- 2012-07
Publications
- Background Chaabane H, Masmoudi A, Dammak A, Kchaou W, Akrout F, Zribi M, Boudaya S, Turki H. [Cryotherapy with or without intralesional antimony in the treatment of cutaneous leishmaniasis]. Ann Dermatol Venereol. 2009 Mar;136(3):278-9. doi: 10.1016/j.annder.2008.09.016. Epub 2008 Dec 3. No abstract available. French.
- Results Ranawaka RR, Weerakoon HS. Randomized, double-blind, comparative clinical trial on the efficacy and safety of intralesional sodium stibogluconate and intralesional 7% hypertonic sodium chloride against cutaneous leishmaniasis caused by L. donovani. J Dermatolog Treat. 2010 Sep;21(5):286-93. doi: 10.3109/09546630903287445.
- Soto J, Rojas E, Guzman M, Verduguez A, Nena W, Maldonado M, Cruz M, Gracia L, Villarroel D, Alavi I, Toledo J, Berman J. Intralesional antimony for single lesions of bolivian cutaneous leishmaniasis. Clin Infect Dis. 2013 May;56(9):1255-60. doi: 10.1093/cid/cit049. Epub 2013 Feb 6.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | pentavalent antimony | Unknown | — | Other |