The study is designed to compare the efficacy of topical gentian violet accompanied with cryotherapy and cryotherapy alone in the treatment of cutaneous leishmaniasis. The study is a randomized, single-blind, controlled with standard treatment, unicenter, phase II clinical trial. Inclusion criteria include clinical diagnosis of cutaneous leishmaniasis and confirmation of diagnosis by direct smear or Polymerase chain reaction test. Exclusion criteria include pregnancy or Lactation, history of consumption of topical or systemic anti-leishmania medications or cryotherapy in the recent 1 month before enrolling in study, patients with more than 10 lesions, patients with lesions lasting more than 4 months, and lesions on the cartilages (Ear or nose). The patients were selected by convenient sampling from cutaneous leishmaniasis patients referred to dermatology clinic of Faghihi hospital in Shiraz and 60 patients were enrolled in the study. The patients were divided into two groups with 25 patients in each by block randomization. Intervention group applied gentian violet 1% ointment two times a day for 8 weeks besides weekly cryotherapy and control group underwent cryotherapy alone once weekly for 8 weeks. Primary outcome measures was clinical cure defined as reduction in lesion size which was assessed in the 4th, and 8th week of the study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017071316557N2
Registration date:2017-08-13, 1396/05/22
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-08-13, 1396/05/22
Registrant information
Name
Mozhdeh Sepaskhah
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 712125239
Email address
sepaskhah@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research grant number 94-01-01-9107 of Research Council of Shiraz University of Medical Sciences
Expected recruitment start date
2015-10-02, 1394/07/10
Expected recruitment end date
2016-02-29, 1394/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of the efficacy of Gentian violet accompanied with cryotherapy in the treatment of old world cutaneous leishmaniasis
Public title
Effect of Gentian violet ointment and cryotherapy on cutaneous leishmaniasis treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Clinical diagnosis of cutaneous leishmaniasis; Confirmation of diagnosis by direct smear or Polymerase chain reaction test
Exclusion criteria: Pregnancy or Lactation; History of consumption of topical or systemic anti-leishmania medications or cryotherapy in the recent 1 month before enrolling in study; Patients with more than 10 lesions; Patients with lesions lasting more than 4 months; Lesions on the cartilages (Ear or nose)
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences, Zand St., Shiraz. Iran
City
Shiraz
Postal code
Approval date
2015-06-10, 1394/03/20
Ethics committee reference number
IR.SUMS.med.REC.1394.29
Health conditions studied
1
Description of health condition studied
Cutaneous leishmaniasis
ICD-10 code
B55.1
ICD-10 code description
Cutaneous leishmaniasis
Primary outcomes
1
Description
Clinical cure
Timepoint
4th and 8th weeks of the study
Method of measurement
complete response defined as more than 75% reduction, partial response defined as 50%–75% reduction, and no response to treatment defined as less than 50% reduction in the size of the lesion compared with baseline. Size is measured by multiplying the longest and shortest diameters of the lesion.
Secondary outcomes
1
Description
Side effects
Timepoint
8th week of the study
Method of measurement
Asking the patient
Intervention groups
1
Description
Intervention: Applying gentian violet 1% ointment twice daily for 8 weeks besides liquid nitrogen cryospray cryotherapy weekly for 8 weeks
Category
Treatment - Drugs
2
Description
Control: Only liquid nitrogen cryospray cryotherapy weekly for 8 weeks