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The efficacy of oral terbinafine in the treatment of cutaneous leishmaniasis

A comparison between combination therapy of oral terbinafine and cryotherapy with systemic glucantime and cryotherapy in the treatment of cutaneous leishmaniasis

Status
Not yet recruiting
Phases
Phase 1
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12609000114246
Enrollment
40
Registered
2009-02-18
Start date
2008-12-08
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Leishmaniasis is a parasitic disease that is endemic in developing countries. The incidence of leishmaniasis is more than 400,000 cases annually and the prevalence of all form of leishmaniasis is more than twelve millions. Although cutaneous leishmaniasis (CL) is a self- healing disease , the duration of the disease is long and requeries several months and somtimes years before complete recovery , depending on the species of the infecting parasite . After recovery, a disfiguring scar can be left , which may destroy underlying structures like the nose or ear or cause psychological suffering of patients . The first line drug for treatment of CL., according to WHO recommendation , is the pentavalent comounds such as meglomine antimoniate (Glucantime [ sb] Other treatment for cutaneous leishmaniasis are intralesinal injection of meglomine antimonate, terbinafine , paramonycin ointment , and physical treatment including cryotherapy (cryosurgery) and therapy .Total clearance or marked improvement by systmic glucantime is reported in 30%. In 1997a pilot study was performed on 27 cutaneous leishmaniasis lesions with terbinafine and 71.5% improvement (28.5% complate recovery and 43% partial recovery) was reported in the pilat study, efficacy of oral terbinafine used for cutaneous leishmaniasis was high and worthy . The present trial was designed to evaluat the efficacy of combination therapy by terbinafine and cryotherapy in the treatment of CL. Compared with systemic glocantime and criyotherapy.

Interventions

oral terbinafine for 4 weeks in a dose of 62.5 mg twice daily for those weighted less than 20 kg, 125 mg twice daily for those weighted 20-40 kg and 250 mg twice daily for those above 40 kg plus cryotherapy at -196 celsius ( liqiud nitrogen) once every other week for 4 weeks; and applied per treated site (infected site) for 5-10 sec

Sponsors

kerman medical university
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
2 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

all of the patients with cutaneous leishmaniasis

Exclusion criteria

pregnancy,lactation,cardio-vascular diseases,renal disease,liver disease

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026