Cutaneous Leishmaniasis. Cutaneous leishmaniasis
Conditions
Interventions
Intervention 1: Intervention: Fluconazole 1 cap 50 mg for each 8kg body weight daily (maximum 400mg) for 6 weeks + Cryotherapy weekly till complete recovery. Intervention 2: Control: placebo1 cap 50
Treatment - Drugs
Placebo
Intervention: Fluconazole 1 cap 50 mg for each 8kg body weight daily (maximum 400mg) for 6 weeks + Cryotherapy weekly till complete recovery
Control: placebo1 cap 50 mg for each 8kg body weight daily (maximum 400mg) for 6 weeks + Cryotherapy weekly till complete recovery
Sponsors
Vice Chancellor for research of Fasa University of Medical Sciences
Eligibility
Sex/Gender
All
Age
5 Years to 100 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: New case of smear positive cutaneous leishmaniasis; Negative past history of leishmaniais; Weight above 10 kilogram; No treatment for leishmaniasis during the previous 3 months; Disease duration of less than 3 months. Exclusion criteria: Pregnancy and lactation; Skin lesions located on face and ear; More than 10 skin lesions; Present or past history of renal or cardiac diseases; Lupoid or sporotrichoid leishmaniasis; Clients with Immunedeficiency, HIV or Diabetes
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recovery rate. Timepoint: 6 weeks (at the end of drug therapy) and 10 weeks after the start of trial. Method of measurement: Degree of induration, Smear positivity, Ulcer area. | — |
Secondary
| Measure | Time frame |
|---|---|
| Leishmania Smear. Timepoint: at the begining and the end of 6th week of treatment. Method of measurement: Laboratory report.;Induration Severity. Timepoint: Weekly till 6th week and 4 weeks later. Method of measurement: palpation and measuring diameter and height of induration.;Area of ulceration. Timepoint: Weekly till 6th week and 4 weeks later. Method of measurement: observation measuring in centimetr square.;Lesion diameter. Timepoint: Weekly till 6th week and 4 weeks later. Method of measurement: observation measured in centimeter by ruler.;Type of cutaneous Leishmania. Timepoint: at the begining of the trial. Method of measurement: observation.;Number of skin lesions. Timepoint: at the start of the trial. Method of measurement: observation.;Time elapsed to present since the begining of the lesion. Timepoint: at the start of the trial. Method of measurement: Asking the participant.;Adverse events. Timepoint: Weekly till 6th week and 4 weeks later. Method of measurement: Asking the participant and examination. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr Ahmad Reza Parhizkar
Fasa Univaersity of Medical Sciences
Outcome results
None listed