RecruitingPhase 1ACTRN12609000113257

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


Sponsor

Kerman medical university

Enrollment

88 participants

Start Date

Jan 1, 2009

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 2 YearssMax Age: 60 Yearss

Inclusion Criteria1

  • 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 Criteria1

  • pregnancy, lactation, the lesions of articular area.

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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 unt

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


Locations(1)

Kerman, Iran, Islamic Republic Of

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ACTRN12609000113257