To compare the efficacy of topical adapalene 0.1% gel versus a combined formula of topical tretinoin 0.025% and erythromycin 4% gel in the treatment of mild to moderate inflammatory acne vulgaris. Patients and Methods.Thirty six patients with inflammatory acne vulgaris (papules and pustules) will enrolled in the study. A split face method was used in which each patient was instructed to use a combined gel formula (tretinoin 0.025% and erythromycin 4%) on the right side of the face and adapalene 0.1% gel on the left side. Each patient must use the same amount of both gels at night. The duration of therapy is 6 weeks
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013040812758N2
Registration date:2013-05-01, 1392/02/11
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-05-01, 1392/02/11
Registrant information
Name
Amar Hameed
Name of organization / entity
Baghdad medical college
Country
Iraq
Phone
7702475782- 00964
Email address
amar@uobaghdad.edu.iq
Recruitment status
Recruitment complete
Funding source
Iraqi Board for Medical specializations
Expected recruitment start date
2009-10-01, 1388/07/09
Expected recruitment end date
2010-10-01, 1389/07/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Topical Adapalene 0.1% Gel versus Topical Combination of (Tretinoin 0.025% and Erythromycin 4%) Gel in Treatment of AcneVulgaris
Public title
Treatment of acne vulgaris
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: All patients with mild to moderate acne vulgaris will enrolled in the study. All patients must without any systemic and / or topical treatment for at least 2 months before starting the study.
Exclusion criteria: Patients excluded from the study were those with severe acne, nodulocystic acne, patients with systemic diseases, pregnant and lactating women.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
36
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iraqi Board for Medical specializations
Street address
Medical Collection Office, P.O. Box 61080 Postal Code 12114,
City
Baghdad
Postal code
12114
Approval date
2009-08-02, 1388/05/11
Ethics committee reference number
1966
Health conditions studied
1
Description of health condition studied
Acne vulgaris
ICD-10 code
L70.0
ICD-10 code description
Acne vulgaris
Primary outcomes
1
Description
Change in acne scoring.(mild,moderate,severe)Mild acne in which the count of pustules is less than 20 and the count of papules is less than 10.
Timepoint
Each patient was instructed to use the same amount of both gels (finger tip method), ½ hour in the 1st night then wash and increase the time by ½ hour in the successive nights till reach 8 hours; thereafter to keep the applications till morning. The duration of therapy was 6 weeks and follow up for another 6weeks.
Method of measurement
The clinical evaluation was done every 3 weeks by 2 dermatologists; the assessment was carried out by counting the inflammatory lesions (papules and pustules) and watching any local side effects
Secondary outcomes
1
Description
The satisfaction of the patient with the treatment.
Timepoint
The clinical evaluation was done every 3 weeks
Method of measurement
The satisfaction of the patients to the treatment is classified into:1- Full satisfaction.2- Partial satisfaction.3 - No satisfaction.
Intervention groups
1
Description
A split face method for application of treatment will used in which each patient instructed to use a combined gel formula of tretinoin 0.025% and erythromycin 4% on the right side of the face and adapalene 0.1% gel on the left side.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Baghdad Teaching Hospital
Full name of responsible person
Ammar Faisal Hameed
Street address
Medical city 61106
City
Baghdad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iraqi Board for Medical Specializations
Full name of responsible person
Prof.Khalifa Sharquie
Street address
Medical Collection Office, P.O. Box 61080
City
Baghdad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iraqi Board for Medical Specializations
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
Department of Dermatology-Baghdad medical college
Full name of responsible person
Dr.Husam Ali Salman
Position
Assistant profeesor
Other areas of specialty/work
Street address
Medical collection office, P.O. Box 61211
City
baghdad
Province
baghdad
Postal code
12114
Phone
00
Fax
Email
husjob2000@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Dermatology-Baghdad University
Full name of responsible person
Dr.Ammar Faisal Hameed
Position
Lecturer
Other areas of specialty/work
Street address
Medical city61106
City
Baghdad
Province
Baghdad
Postal code
Phone
00
Fax
Email
amar@uobaghdad.edu.iq
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Dermatology-Baghdad University
Full name of responsible person
Dr Ammar Faisal Hameed
Position
Lecturer
Other areas of specialty/work
Street address
Medical city 61106
City
baghdad
Province
baghdad
Postal code
12114
Phone
00
Fax
Email
amar@uobaghdad.edu.iq
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)