|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
IRCT |
|
Last refreshed on:
|
22 February 2018 |
|
Main ID: |
IRCT2013040812758N2 |
|
Date of registration:
|
2013-05-01 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Treatment of acne vulgaris
|
|
Scientific title:
|
Topical Adapalene 0.1% Gel versus Topical Combination of (Tretinoin 0.025% and Erythromycin 4%) Gel in Treatment of AcneVulgaris |
|
Date of first enrolment:
|
2009-10-01 |
|
Target sample size:
|
36 |
|
Recruitment status: |
Complete |
|
URL:
|
http://en.irct.ir/trial/12757 |
|
Study type:
|
interventional |
|
Study design:
|
Randomization: N/A, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Iraq
| | | | | | | |
|
Contacts
|
|
Name:
|
Dr.Ammar Faisal Hameed
|
|
Address:
|
Medical city61106
Baghdad
Iraq |
|
Telephone:
|
00 |
|
Email:
|
amar@uobaghdad.edu.iq |
|
Affiliation:
|
Department of Dermatology-Baghdad University |
|
|
Name:
|
Dr.Husam Ali Salman
|
|
Address:
|
Medical collection office, P.O. Box 61211
12114
baghdad
Iraq |
|
Telephone:
|
00 |
|
Email:
|
husjob2000@yahoo.com |
|
Affiliation:
|
Department of Dermatology-Baghdad medical college |
| |
|
Key inclusion & exclusion criteria
|
Inclusion 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.
Exclusion criteria:
Age minimum:
no limit
Age maximum:
no limit
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Acne vulgaris
|
Acne vulgaris.
Acne vulgaris
|
|
Intervention(s)
|
|
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..
|
|
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.
|
|
Treatment - Drugs
|
|
Primary Outcome(s)
|
|
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 Outcome(s)
|
|
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.
|
|
Source(s) of Monetary Support
|
|
Iraqi Board for Medical Specializations
|
|
Ethics review
|
Status: Approved
Approval date:
Contact:
Iraqi Board for Medical specializations
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|