Evaluation of sensitization by Candida antigen in comparison with cryotherapy in treatment of wart lesions in patients referring to dermatology clinic of Quaem hospital
This study was conducted from December 2013 through February 2014 among patients aged more than 15 years old with verruca vulgaris and plantar warts. They were neither pregnant, lactating nor have any evidence of known immunodeficiency. Cases were referred to dermatology clinic of Quaem Hospital. After giving information about methodology and objectives, those people who were qualified enrolled and written consent was taken. They randomly divided into two groups of 30 peoples (Group A and B) based on the day of referral. Group A was given 0.1 ml of Candidate antigen intralesionally into the greatest lesions each 3 weeks apart for a total of three doses and group B was under treatment with liquid nitrogen cryotherapy weekly till 10 weeks or otherwise complete improvement in less sessions. Then improvement response and side effects was compared between two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015012016955N5
Registration date:2015-11-26, 1394/09/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-11-26, 1394/09/05
Registrant information
Name
Pouran Layegh
Name of organization / entity
department of dermatology, Ghaem hospital, Mashhad, Iran
Country
Iran (Islamic Republic of)
Phone
+98 51 1801 2861
Email address
momenzadeha1@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Mashhad University of Medical Sciences
Expected recruitment start date
2013-12-22, 1392/10/01
Expected recruitment end date
2014-02-19, 1392/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of sensitization by Candida antigen in comparison with cryotherapy in treatment of wart lesions in patients referring to dermatology clinic of Quaem hospital
Public title
Treatment response of wart lesions to sensitization by Candida antigen in comparison with cryotherapy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients older than 15 years that have verucca vulgaris and plantar warts whom referred to dermatology clinic of Quaem hospital;
no prior allergic response to mumps or Candida antisera; not be pregnant or lactating; no primary or iatrogenic immuno-supression; no infection with human immunodeficiency virus type 1( HIV1); no hypersensitivity to lidocaine; no previous treatment for wart during 1 month ago
Exclusion criteria:Taking any treatment for wart during study
Age
From 15 years old to 75 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
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
Ethics Committee of Mashhad University of Medical Sciences
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi),Daneshgah 16, Daneshgah Street
City
Mashhad
Postal code
Approval date
2011-09-23, 1390/07/01
Ethics committee reference number
911047
Health conditions studied
1
Description of health condition studied
wart
ICD-10 code
A18.4
ICD-10 code description
common wart
Primary outcomes
1
Description
Lesion improvement rate
Timepoint
Weekly for cryotherapy until 10 weeks, every 3 weeks for Candida antigen until three doses
Method of measurement
Measuring the size of two largest perpendicular diameter of lesion in millimeter
Secondary outcomes
1
Description
Side effects
Timepoint
Weekly for cryotherapy group and each 3 weeks for candida antigen group
Method of measurement
Clinical evaluation
Intervention groups
1
Description
Use of 1.1000 purified candida antigen solution (Greer, USA) intralesionally into greatest wart lesions every 3 weeks for 3 doses in intervention group.
Category
Treatment - Drugs
2
Description
Use of cryotherapy with liquid nitrogen weekly for 10 weeks in control group.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dermatology clinic, Quaem Hospital
Full name of responsible person
Dr Pouran Layegh
Street address
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah street
City
Mashhad
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 of Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Dr Pouran Layegh
Position
Associate professor of Dermatology
Other areas of specialty/work
Street address
Dermatology clinic, Quaem hospital, Ahmad Abad Street
City
Mashhad
Postal code
Phone
+98 51 3801 2851
Fax
Email
layeghpo@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Pouran Layegh
Position
Associate professor of Dermatology
Other areas of specialty/work
Street address
Dermatology clinic, Mashhad University of Medical Sciences
City
Mashhad
Postal code
Phone
+98 51 3801 2851
Fax
Email
layeghpo@mums.ac.i; src@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Zahra Montazer Abadi
Position
Bachelor of Biology
Other areas of specialty/work
Street address
Cutaneous Leishmaniasis Research Center, Mashhad University of Medical Sciences
City
Mashhad
Postal code
Phone
+98 51 3841 0135
Fax
Email
src@mums.ac.ir; MontazerZ911@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)