Comparison of the therapeutic efficacy and safety of 10% Potassium hydroxide (KOH) solution versus 50% Trichloroacetic acid (TCA) solution in the treatment of plane warts
Comparison of the therapeutic efficacy and safety of 10% Potassium hydroxide (KOH) solution versus 50% Trichloroacetic acid (TCA) solution in the treatment of plane warts.
Design
In this interventional RCT, 64 patients that attending dermatology department of Emam hospital with diagnoses of plane warts are included in the study. Patients will be randomly assigned into two groups with 32 members that will be treated by KOH 10% and TCA 50% for 12 weeks and the results will be compared at the end of the study.
Settings and conduct
The study is triple blind. Patient, doctor and data analyzer are blind. The appearance of the drugs are similar and they are in A and B bottles and only one person in dermatology ward who is not involved in the project knows the type of drugs.
Participants/Inclusion and exclusion criteria
Inclusion criteria: being at the age of 4 years and over, number of warts between 3-30.
Exclusion criteria: Pregnancy; breast feeding; Patients with hypersensitivity to KOH or TCA; Patients who are currently using any other treatment for warts; Patients who are unable to return for follow up visits or comply with the protocol; patients with high wart count (>30).
Intervention groups
Patients are divided into two 32-member groups. One group is treated with KOH 10% and second group is treated with TCA 50%.
Main outcome variables
Wart number; wart size
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170829035976N2
Registration date:2018-02-05, 1396/11/16
Registration timing:registered_while_recruiting
Last update:2018-02-05, 1396/11/16
Update count:0
Registration date
2018-02-05, 1396/11/16
Registrant information
Name
Bahareh Maleki
Name of organization / entity
Dermatologist
Country
Iran (Islamic Republic of)
Phone
+98 61 3391 2191
Email address
maleki.b@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-08-23, 1396/06/01
Expected recruitment end date
2018-02-19, 1396/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the therapeutic efficacy and safety of 10% Potassium hydroxide (KOH) solution versus 50% Trichloroacetic acid (TCA) solution in the treatment of plane warts
Public title
Effect of 10% Potassium hydroxide and 50% Trichloroacetic acid on plane warts
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
being at the age of 4 years old and over
Number of warts 3-30
Exclusion criteria:
Pregnancy
Breast feeding
High wart count (more than 30)
Hypersensitivity to KOH or TCA
Unable to return for follow up
Other treatment in the previous one month
Age
From 4 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done through block randomization using blocks of size 4
Blinding (investigator's opinion)
Triple blinded
Blinding description
The study is triple blind. Patient, doctor and data analyzer are blind. The appearance of the drugs are similar and they are in A and B bottles and only one person in dermatology ward who is not involved in the project knows the type of drugs
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee Of Ahvaz Jundishapur University Of Medical Sciences
Street address
Ethics committee, Room number4, Ground flour, Ahvaz Jundishapur University Of Medical Sciences, Shahre Daneshgahi, Golestan, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2017-12-05, 1396/09/14
Ethics committee reference number
IR.AJUMS.REC.۱۳۹۶.۷۰۳
Health conditions studied
1
Description of health condition studied
plane wart
ICD-10 code
B07
ICD-10 code description
Verruca: simplex vulgaris
Primary outcomes
1
Description
Wart Number
Timepoint
Before intervention, 4, 8, 12 weeks after intervention, 1 month after full response
Method of measurement
Number
2
Description
Wart size
Timepoint
Before intervention, 4, 8, 12 weeks after intervention, 1 month after full response
Method of measurement
Ruller
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: The group which is treated with potassium hydroxide 10% (KOH) weekly for 12 weeks. The drug is produced by Merck company, Germany. The drug code is 1.05032.1000.
Category
Treatment - Drugs
2
Description
Intervention group 2: The group which is treated with trichloroacetic acid 50%, weekly for 12 weeks. The drug is produced by Merck company, Germany. The drug code is 1.00810.0250