Cutaneous leishmaniasis is a protozoan disease with an annual incidence of almost 2 million new cases worldwide making it one of the most common infectious diseases globally. To compare the effect of topical nitric oxide 3% and Cryotherapy with Cryotherapy and placebo in the treatment of cutaneous leishmaniasis, 100 patients (50 patients in each group) with cutaneous leishmaniasis were randomized to receive either topical nitric oxide3% and cryotherapy or cryotherapy and placebo for 12 weeks. Patients received cryotherapy once a week and topical nitric oxide or placebo three times a day. They were visited every other week for evaluation of response rate with measuring the diameters of the largest lesion and probable side effects.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138710191535N1
Registration date:2009-07-05, 1388/04/14
Registration timing:retrospective
Last update:
Update count:0
Registration date
2009-07-05, 1388/04/14
Registrant information
Name
Farideh Dehghani
Name of organization / entity
Shiraz University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 77 1230 5410
Email address
dehghanifa@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Science
Expected recruitment start date
2007-09-20, 1386/06/29
Expected recruitment end date
2009-02-20, 1387/12/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of efficacy of topical nitric oxide 3% and cryotherapy with cryotherapy and placebo in cutaneous leishmaniasis
Public title
Evaluation of efficacy of topical nitric oxide in treatment of cutaneous leishmaniasis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age more than 12 years, less than 5 active lesion, no topical treatment from 2 weeks prior to study and no systemic treatment from 1 month prior to study,
Exclusion criteria: pregnancy and lactation, facial lesions, lesions with more than 4 months duration
Age
From 12 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ُSُhiraz University of Medical Science
Street address
Karim Khan Zand Boulevard.
City
Shiraz
Postal code
7134844119
Approval date
2007-04-09, 1386/01/20
Ethics committee reference number
ct-86-3665
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
Complete improvement
Timepoint
Baseline, every other week
Method of measurement
measurment of erythema and induration diameter with a ruler
Secondary outcomes
1
Description
Side effects
Timepoint
every other week
Method of measurement
medical history taking and physical examination
Intervention groups
1
Description
Intervention: topical nitric oxide 3 percent 3 times a day + cryotherapy once a week for 12 weeks
Category
Treatment - Drugs
2
Description
Control: placebo cream 3 times a day + cryotherapy once a week for 12 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Faghihi Hospital, dermatology clinic
Full name of responsible person
Farideh Jowkar, MD.
Street address
Shahid Faghihi hospital, Karimkhan Zand Boulevard
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
ُShiraz University of Medical Sciences
Full name of responsible person
Mohammad Hosein Dabaghmanesh,MD
Street address
Karim Khan Zand Boulevard, Shiraz University of Medical Sciences
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?