Comparison of the efficacy of cryotherapy and 0.1 % acnalen gel vs. cryotherapy alone in the treatment of actinic keratoses: a randomized, double-blind clinical trial
The purpose of this study is to evaluate the efficacy of cryotherapy followed by Acnalene 0.1% gel. This study is a randomized, double-blind clinical trial. Cryotherapy is performed for 100 patients with single freeze-thaw cycle which forms a 2mm ring around the lesions, then patients receive either Acnalene gel and placebo from 10th day to 3 months (90 days). Drugs are applied twice daily on entire affected area of skin. Patients are evaluated on days 10, 40, 70, and 100 of the study. The outcome measure is estimated by reducing the number of lesions in the treated areas.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201010104901N1
Registration date:2010-10-31, 1389/08/09
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-10-31, 1389/08/09
Registrant information
Name
Hmideh Azimi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1331 1819
Email address
azimihamideh@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Aburaihan company
Expected recruitment start date
2010-01-05, 1388/10/15
Expected recruitment end date
2011-01-20, 1389/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of cryotherapy and 0.1 % acnalen gel vs. cryotherapy alone in the treatment of actinic keratoses: a randomized, double-blind clinical trial
Public title
Comparison of the efficacy of cryotherapy and 0.1 % acnalen gel vs. cryotherapy alone in the treatment of actinic keratoses: a randomized, double-blind clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Clinical diagnosis of actinic keratosis, At least 5 lesions, Willing to participate in the study
Exclusion criteria: Pregnancy (first trimester), Previous history of allergy to drugs of study, Use of destructive methods or drugs for treatment of lesions over the last month, Use of Isotretinoine over the last 2 months, Use of peeling methods over the last month, Participation in the other clinical studies over the past month
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
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
Tabriz University Of Medical Sciences
Street address
Golgasht Ave
City
Tabriz
Postal code
Approval date
2010-06-24, 1389/04/03
Ethics committee reference number
54/1745
Health conditions studied
1
Description of health condition studied
Actinic keratoses
ICD-10 code
ICD-10 code description
Actinic keratoses
Primary outcomes
1
Description
Clearance of lesions
Timepoint
Baseline and then monthly
Method of measurement
Number of lesions
Secondary outcomes
1
Description
Side effects
Timepoint
Monthly
Method of measurement
Medical history and physical examination
Intervention groups
1
Description
Cryotherapy at the beginning + Acnalene 0.1% gel twice daily for 3 months
Category
Treatment - Drugs
2
Description
Control group: Cryotherapy at the begining + placebo twice daily for 3 months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina hospital
Full name of responsible person
Street address
Azadi Ave
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Aburaihan Company
Full name of responsible person
Dr M.Hakimi
Street address
No 1, Tirandaz Ave, Tehranpars threeway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Aburaihan Company
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
Tabriz University of Medical Sciences
Full name of responsible person
Mahnaz Jaberian
Position
Resident of dermatology
Other areas of specialty/work
Street address
Golgasht Ave
City
Tabriz
Postal code
Phone
+98 44 1331 1819
Fax
Email
jaberian_m@hotmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hamideh Azimi
Position
Dermatologist, Assistant Professor
Other areas of specialty/work
Street address
Golgasht Ave
City
Tabriz
Postal code
Phone
+98 44 1541 2101
Fax
Email
azimihamideh@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mahnaz Jaberian
Position
Resident of dermatology
Other areas of specialty/work
Street address
City
Tabriz
Postal code
Phone
Fax
Email
jaberian_m@hotmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)