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The comparison between topical terbinafine and placebo in the treatment of cutaneous leishmaniasis

The comparison between topical terbinafine and placebo in the treatment of cutaneous leishmaniasis

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12609000113257
Enrollment
88
Registered
2009-02-18
Start date
2009-01-01
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). Other treatment for cutaneous leishmaniasis are intralesinal injection of meglomine antimonate, terbinafine , paramonycin ointment , and physical treatment including cryotherapy .the aim of this atudy is to determine the efficacy of topical terbinafine in the treatment of cutaneous leishmaniasis.

Interventions

Topical terbinafine 2% cream twice daily until 10 weeks was applied on the cutaneous leishmaniasis lesions + intralesional injection of glucantime (435 mg of sb5+, active antimony) once per week until 10 weeks

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

age>2 years, the size of lesion<3cm, the number of lesions<4, the patients whom did not injected glucantim, the patinets whom did not receive any treatment for leishmaniasis within last month.

Exclusion criteria

pregnancy, lactation, the lesions of articular area.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026