Protocol summary

Summary
Study of efficacy intralesional injection tuberculin antigen in the treatment of multiple common warts. A randomized, double-blind, placebo-controlled clinical trial. Patients and researchers were blinded. Inclusion criteria: Patients with multiple common warts with past history of BCG vaccination or positive tuberculin test PPD greater than 5 millimeter or obviously scar in the upper left arm, Multiple warts equally or more than three wart. Exclusion criteria: Pregnancy or lactation, Immunosuppressive patients, Past history of TB disease, Sever reaction such as anaphylaxis to tuberculin antigen, Any generalized dermatitis, receiving other treatments for wart, receiving first and second generation anti TB drugs. The study was carried out in dermatologic outpatient clinic, Ahvaz University Hospital, after obtaining the informed consent from all patients and parents of children. Our study included 54 patients with multiple common warts. Patient was classified into 2 groups: First group included 27 patients treated with IL (intra wart) tuberculin antigen with a dose of 0.1 ml by insulin syringe. Second group included 27 patients treated with IL saline with a dose of 0.1 ml. In both groups, injections were made into the largest one of the multiple common warts. Injections were repeated for all patients every one week for a total of six injections or less in cases of resolution of warts. At the first visit, the duration, location, number, diameter of all warts were reported. Response of distant, anatomically distinct, untreated warts was also noted. Response to treatment was evaluated by the decrease in size of warts and by photographic comparison. The response was considered complete if there was disappearance of 75-100% warts and return of normal skin marking , partial if the warts had regressed in size and number by 50-74% , minimal response if the was regressed in size and number by 25-49% and no response if the warts had regressed in size and number by leaser than 25%. Immediate and late adverse effects of tuberculin antigen were evaluated after each treatment session. After the sixth injection, if wart was not completely healed, the patient refer for cryotherapy. Follow up was made every two months for six months to detect any recurrence.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015080323486N1
Registration date: 2015-12-02, 1394/09/11
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-12-02, 1394/09/11
Registrant information
Name
Farzaneh Alamshahi
Name of organization / entity
Ahvaz JundiShapur of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 639 2961
Email address
alamshahi.f@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapur University of Medical Sciences, Vice chancellor for research
Expected recruitment start date
2014-09-23, 1393/07/01
Expected recruitment end date
2015-10-22, 1394/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison study of efficacy intralesional injection of tuberculin antigen and placebo in the treatment of multiple common warts
Public title
Study of efficacy injection tuberculin in the treatment of warts
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with multiple common warts with past history of BCG vaccination or positive tuberculin test PPD greater than 5 millimeter or obviously scar in the upper left arm, Multiple warts equally or more than three wart. Exclusion criteria: Pregnancy or lactation, Immunosuppressive patients, Past history of TB disease, Sever reaction such as anaphylaxis to tuberculin antigen, Any generalized dermatitis, receiving other treatments for wart, receiving first and second generation anti TB drugs.
Age
From 15 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 54
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
Ethics committee of Ahvaz Jundishpur University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd
City
Ahvaz
Postal code
Approval date
2014-10-11, 1393/07/19
Ethics committee reference number
ajums.REC.1393.229

Health conditions studied

1

Description of health condition studied
Multiple common warts
ICD-10 code
B07
ICD-10 code description
Viral warts

Primary outcomes

1

Description
size and number of wart
Timepoint
at start of the study and at each episode of treatment
Method of measurement
measurement diameter of wart with ruler and by photographic comparison

Secondary outcomes

1

Description
side effect
Timepoint
at each treatment session
Method of measurement
history and physical examination

2

Description
recurrence of wart
Timepoint
Every two months for 6 months after complete response
Method of measurement
physical examination

Intervention groups

1

Description
Intervention group:Injection of 0.1 ml PPD antigen into the largest one of warts at one week intervals for a maximum of six treatments
Category
Treatment - Drugs

2

Description
Control groups:Injection of 0.1 ml normal saline into the largest one of the warts at one-week intervals for a maximum of six treatments.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Ahvaz Imam khomeini hospital-Dermatology clinic
Full name of responsible person
Street address
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences, Vice chancellor for research
Full name of responsible person
Nader saki
Street address
Ahvaz University of Medical Sciences , University Town, Ahvaz
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz Jundishapur University of Medical Sciences, Vice chancellor for research
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
Ahvaz jundishapur University of Medical Sciences, Vice chancellor for research
Full name of responsible person
Farzaneh Alamshahi
Position
Resident of Dermatology
Other areas of specialty/work
Street address
Golestan high way, the main gait of Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
City
Ahvaz
Postal code
61357-15794
Phone
+98 613336754360
Fax
Email
info@ajums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences, Vice chancellor for research
Full name of responsible person
Dr Reza yaghoubi
Position
full professor
Other areas of specialty/work
Street address
Department of Dermatology, Emam Khomeini Hospital, 61335-4156, Ahvz,Iran
City
Ahvaz
Postal code
Phone
+98 61 3338 5488
Fax
Email
Yaghoobi_RZ@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences, Vice chancellor for research
Full name of responsible person
Farzaneh Alamshahi
Position
Resident of Dermatology
Other areas of specialty/work
Street address
City
Khuzestan
Postal code
Phone
+98 912 639 2961
Fax
Email
Dr.alamshahi@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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