Purpose: The comparison of efficacy and safety of topical potassium hydroxide 5% and topical retinoid 0.1% in the treatment of plane wart
Design of the study: randomized
The population of the study: patients with at least three lesions of plane wart
Sample size: 72 patients, 36 patients in each group
Interventions: application of topical 5% hydroxide potassium solution in one group and topical 0.1% retinoid lotion in another group
Time of intervention: 23-10-2009 until 06-08-2010
Outcome: both drugs have similar efficacy in the treatment of plane wart, adverse drug reaction was higher in KOH group than retinoid group.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201201038516N2
Registration date:2012-03-10, 1390/12/20
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-03-10, 1390/12/20
Registrant information
Name
Mahroo Tajalli
Name of organization / entity
Ahvaz Jundishapur University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 14 1322 0101
Email address
tajalli.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz jundishapur University of Medical Science
Expected recruitment start date
2009-10-23, 1388/08/01
Expected recruitment end date
2010-08-06, 1389/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of efficacy and safety of topical 5% potassium hydroxide solution and topical 0.1% retinoid lotion in the treatment of plane wart
Public title
Comparison of efficacy and safety of topical 5% potassium hydroxide solution and topical 0.1% retinoid lotion in the treatment of plane wart
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criterion: presence of at least three lesion
Exclusion criteria:
1-Pregnancy
2-Lactation
3-Patients that have received treatment in the recent four weeks
4-Secondary infection
5-Involvement of the genital area
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ahvaz Jundishapurl university of medical science
Street address
Ahvaz Jundishapurl university of medical science-Golestan Blvd-Ahvaz-Khuzestan-Iran
City
Ahvaz
Postal code
Approval date
2009-10-17, 1388/07/25
Ethics committee reference number
ETH-030
Health conditions studied
1
Description of health condition studied
plane wart
ICD-10 code
B00-B09
ICD-10 code description
Viral infections characterized by skin and mucous membrane lesions
Primary outcomes
1
Description
Improvement
Timepoint
2 weeks, 4 weeks, 6 weeks after initiation of the treatment and 2 weeks after the end of the treatment
Method of measurement
Based on the count of lesions
Secondary outcomes
1
Description
Adverse drug reaction
Timepoint
2 weeks, 4 weeks, 6 weeks after the initiation of the treatment and 2 weeks after the end of the treatment
Method of measurement
Based on occurrence of various adverse reaction
Intervention groups
1
Description
Topical 5% potassium hydroxide solution was applied on the lesions using cotton swap by patients or their parents, and then patients were evaluated regarding efficacy and safety of the drugs 2, 4, 6 weeks after the initiation of the treatment and 2 weeks after the end of the treatment.
Category
Treatment - Drugs
2
Description
In the other group topical 0.1 % retinoid lotion was applied on the wart lesions by the patient or their parents and the patients were evaluated regarding the efficacy and safety 2, 4, 6 weeks after the initiation of the treatment and 2 weeks after the end of treatment.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of dermatology-Imam Khomeini hospital-Ahvaz