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

Plain Language Summary

Simplified for easier understanding

This study is testing whether a cream containing terbinafine (an antifungal medication) applied to the skin can treat cutaneous leishmaniasis — a parasitic skin disease that causes long-lasting sores and can leave scars. The disease is common in developing countries. Half the participants will receive the active cream and half will receive a placebo (dummy) cream, and researchers will track whether the sores heal over time. The goal is to find a simpler, less painful treatment than the current standard injections. You may be eligible if: - You are 2 years of age or older (up to 60 years) - Your skin lesion is smaller than 3 cm - You have fewer than 4 lesions - You have not previously received glucantime (standard injections) for this condition - You have not received any leishmaniasis treatment in the past month You may NOT be eligible if: - You are pregnant or breastfeeding - Your sores are on or near a joint Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

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

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12609000113257