Comparison of efficacy of application viable BCG vaccine paste versus placebo in the treatment of common wart: a double-blind and randomized placebo-control clinical trial
Comparison of efficacy of application viable BCG vaccine paste in the treatment of common wart versus placebo: a double-blind and randomized placebo-control clinical trial.
Abstract: Treatment of verrucae is difficult and may be painful or scaring especially by using traditional destructive methods .
The aim of current study is evaluation of the efficacy and safety of topical application of viable Bacillus Calmette-Guerine(BCG) in the form of paste as a new and safe immunotherapeutic modality in treatment of common warts.
Method and material: This double blind randomized clinical trial study is carried out in patients who were divided into two groups: patients in case group(40 patients) receive topical BCG paste (BCG+salicylic acid +glycerin) and patients in control group(40 patients) receive placebo (salicylic acid+glycerin) with similar shape and color of the BCG paste. Treatment protocols in two groups are topical weekly application for 8 consecutive weeks.patients who have no response in both group will be treat by cryotherapy.
Follow up will be done every 2 weeks during treatment and 8 weeks after the end of treatment for evaluation of recurrence .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014101419527N1
Registration date:2015-10-21, 1394/07/29
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-10-21, 1394/07/29
Registrant information
Name
Sedighe Tavakoli
Name of organization / entity
Jundishapur University of Medical Science,Ahvaz
Country
Iran (Islamic Republic of)
Phone
+98 29 21837
Email address
tavakoli.s@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapur University Sciences
Expected recruitment start date
2014-11-22, 1393/09/01
Expected recruitment end date
2015-11-22, 1394/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of efficacy of application viable BCG vaccine paste versus placebo in the treatment of common wart: a double-blind and randomized placebo-control clinical trial
Public title
Treatment of common wart with topical BCG vaccine
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with common wart without any limitation on patients age; patients sex; wart numbers; distribution of lesions; duration of disease.
Exclusion criteria: any treatment in the 3 months ago؛ no BCG immunization; no immune deficiency due to drug or chronic disease; hypersensitivity to BCG; presence of febrile disease; chronic disease induced immunodeficiency such as diabetes melitus; presence of allergic skin disease such as urticaria.
Age
From 1 year old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
40
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
Ahwaz Jundishapur Univercity of Medical Science
Street address
Department of Development Research and Technology ahwaz jundishapur University of Medical Sciences and Heaith care,University town,Ahwaz
City
Ahwaz
Postal code
61357-15794
Approval date
2014-10-04, 1393/07/12
Ethics committee reference number
13930210
Health conditions studied
1
Description of health condition studied
common wart
ICD-10 code
B07
ICD-10 code description
Viral warts
Primary outcomes
1
Description
Wart size change
Timepoint
Every 2 week
Method of measurement
With ruler
Secondary outcomes
1
Description
Erythema, Bleeding, Pain
Timepoint
Every week
Method of measurement
Questionaaire
Intervention groups
1
Description
interventional group:in this group 40 patients treat with topical BCG weekly for 8 consecutive week.1 cc BCG and 3cc glycerin combine and applicate on warts. dress with plastic and wash after 2hours.patients evaluate every 2week for complications, response to treatment and photography.patients also evaluate for recurrence 8 week after end of treatment.cryotherapy will be done if not response to BCG.
Category
Treatment - Drugs
2
Description
control group: in this group 40 patients treat with topical glycerin weekly for 8 consecutive week.3cc glycerin applicate on warts. dress with plastic and wash after 2hours.patients evaluate every 2week for complications, response to treatment and photography. patients also evaluate for recurrence 8 week after end of treatment.cryotherapy will be done if not response to glycerin.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahwaz Emam Khomeini hospital dermatology department