Objectives: To assess the effect of topical capsaicin versus cryotherapy on clinical signs in patients with verruca vulgaris.
Design: a randomized clinical trial.
Setting and conduct: The eligible patients with verruca vulgaris who will refer to Farshchian Hospital during the study period will be enrolled into the trial.
Inclusion criteria: (a) age between 5 to 70 years; (b) having at least one wart with 5 mm diameter on the dorsum of the hand.
Exclusion criteria: (a) immunodeficiency; (b) pregnancy.
Intervention group: Topical capsaicin three a day for 6 weeks
Control group: Cryotherapy every two weeks for 6 weeks
Primary outcome: Measuring diameter of wart using vernier ruler 6 weeks after beginning of treatment.
Secondary outcome: (a) assessing erythema through question 6 weeks after beginning of treatment; (b) assessing local pain or burning through question 6 weeks after beginning of treatment.
Randomization: The patients will be randomly assigned to intervention and control groups through drawing of lots.
Blinding: Not possible.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201601179014N89
Registration date:2016-01-21, 1394/11/01
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-01-21, 1394/11/01
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2015-11-22, 1394/09/01
Expected recruitment end date
2016-03-20, 1395/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of topical capsaicin versus cryotherapy on clinical sign in patients with verruca vulgaris: a randomized clinical trial
Public title
Effect of topical capsaicin versus cryotherapy on clinical sign in patients with verruca vulgaris
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: (a) age between 5 to 70 years; (b) having at least one wart with 5 mm diameter on the dorsum of the hand.
Exclusion criteria: (a) immunodeficiency; (b) pregnancy.
Age
From 5 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
108
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization: The patients will be randomly assigned to intervention and control groups through drawing of lots.
Blinding: Not possible.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Approval date
2015-12-26, 1394/10/05
Ethics committee reference number
IR.UMSHA.REC.1394.414
Health conditions studied
1
Description of health condition studied
Verruca vulgaris
ICD-10 code
B07
ICD-10 code description
Viral warts
Primary outcomes
1
Description
Diameter of wart
Timepoint
6 weeks after beginning of treatment
Method of measurement
using vernier ruler
Secondary outcomes
1
Description
Erythema
Timepoint
6 weeks after beginning of treatment
Method of measurement
through question
2
Description
Local pain or burning
Timepoint
6 weeks after beginning of treatment
Method of measurement
through question
Intervention groups
1
Description
Topical capsaicin three a day for 6 weeks
Category
Treatment - Drugs
2
Description
Cryotherapy every two weeks for 6 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Farshchian Hospital
Full name of responsible person
Leila Khezrian
Street address
Farshchian Hospital, Mirzadeh Eshghi Ave.
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Farshchian Hospital
Full name of responsible person
Leila Khezrian
Position
Medical Student
Other areas of specialty/work
Street address
Farshchian Hospital, Mirzadeh Eshghi Ave.
City
Hamadan
Postal code
Phone
+98 81 3827 4184
Fax
Email
khezrian.leila@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Farshchian Hospital
Full name of responsible person
Dr Gholamreza Eshghi
Position
Dermatologist
Other areas of specialty/work
Street address
Farshchian Hospital, Mirzadeh Eshghi Ave.
City
Hamadan
Postal code
Phone
+98 81 3827 4184
Fax
Email
gholamrezaeshghi58@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Epidemiology
Full name of responsible person
Dr Jalal Poorolajal
Position
Associate Professor
Other areas of specialty/work
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Fax
Email
poorolajal@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)