Cutaneous Leishmaniasis Clinical Trial
Official title:
Short Course of Intralesional Antimony for Bolivian Cutaneous Leishmaniasis
Verified date | July 2018 |
Source | Fundacion Nacional de Dermatologia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 90 |
Est. completion date | July 2012 |
Est. primary completion date | July 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years and older |
Eligibility | INCLUSION CRITERIA: - Gender: Male or female - Age: >12 yrs of age - Clinicla presentation: 1-2 ulcerative lesions, each < 30 mm in largest diameter, and with a total lesion area <900 mm2. - Parasitological confirmation of the lesion will be made by visualization or culture of leishmania from the biopsy or aspirate of the lesion. EXCLUSION CRITERIA: - Previous treatment for leishmaniasis: therapy with Sb, pentamidine, amphotericin B, miltefosine, imidazoles or allopurinol in the last 3 months - Concomitant diseases by history that would be likely in the PI's opinion to interact, either positively or negatively, with IL Sb treatment. |
Country | Name | City | State |
---|---|---|---|
Bolivia | CUNETROP - Universidad Mayor de San Simon | Cochabamba | CB |
Bolivia | Hospital Dermatologico de Jorochito | Jorochito | SC |
Lead Sponsor | Collaborator |
---|---|
Fundacion Nacional de Dermatologia | Hospital Dermatológico de Jorochito, Proyecto OSCAR, The Alfred Berman Foundation for Medical Research, Universidad Mayor de San Simón |
Bolivia,
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. French. — View Citation
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 Derm — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Complete clinical cure | 100% epithelization, complete resolution of swelling and infiltration | six months | |
Secondary | EKG changes associated with IL Sb, local reactions to cream and Cryo | Ealuation of clinical findings and changes in OKG, lipase and SGOT in patients receiving intralesional antimony | six months |
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