| CTRI Number |
CTRI/2021/04/033182 [Registered on: 28/04/2021] Trial Registered Prospectively |
| Last Modified On: |
26/05/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Management of Mild to Moderate Facial Acne Vulgaris |
|
Scientific Title of Study
|
Comparative study on the efficacy and safety of Adapalene vs Benzoyl peroxide in patients with mild to moderate facial acne vulgaris in tertiary care hospital |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ashwini T |
| Designation |
Post Graduate Student |
| Affiliation |
SREE BALAJI MEDICAL COLLEGE AND HOSPITAL |
| Address |
No.7,works road,New colony,
Dept. of Pharmacology,
Sree Balaji Medical College,
Chrompet
Kancheepuram
TAMIL NADU
600044
India |
| Phone |
7550078080 |
| Fax |
|
| Email |
dr.t.ashwini@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrIGlory Josephine |
| Designation |
Professor of the Department |
| Affiliation |
SREE BALAJI MEDICAL COLLEGE AND HOSPITAL |
| Address |
No.7,works road,New colony,
Dept. of Pharmacology,
Sree Balaji Medical College,
Chrompet
Kancheepuram
TAMIL NADU
600044
India |
| Phone |
9840230181 |
| Fax |
|
| Email |
dr.gloryj@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ashwini T |
| Designation |
Post Graduate Student |
| Affiliation |
SREE BALAJI MEDICAL COLLEGE AND HOSPITAL |
| Address |
No.7,works road,New colony,
Dept. of Pharmacology,
Sree Balaji Medical College,
Chrompet
Kancheepuram
TAMIL NADU
600044
India |
| Phone |
7550078080 |
| Fax |
|
| Email |
dr.t.ashwini@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Ashwini T |
| Address |
No.7,works Road,New colony,
Dept. of Pharmacology,
Sree Balaji Medical College and Hospital
Chrompet,Chennai 600044 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Ashwini T |
Sree Balaji Medical College and Hospital |
Dept. of Pharmacology,Sree Balaji Medical College and Hospital,Chrompet,Chennai
Kancheepuram
TAMIL NADU |
7550078080
dr.t.ashwini@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sree Balaji Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L700||Acne vulgaris, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
0.1% adapalene gel |
0.1% adapalene gel OD |
| Comparator Agent |
2.5% benzoyl peroxide gel |
2.5% benzoyl peroxide gel OD |
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Patients of both genders of age group between 13 to 40 years with mild to moderate facial acne vulgaris who are willing to participate in study were included |
|
| ExclusionCriteria |
| Details |
Pregnancy and lactation
Patient not willing to participate and not willing to come for follow-up
Patients with drug induced acneiform eruptions
Patients with history of allergy to adapalene and benzoyl peroxide
Patients with pre-existing chronic systemic illness
Patients with severe and cystic acne vulgaris
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effects of Adapalene and Benzoyl Peroxide in terms of lesion reduction will be evaluated |
Baseline,4weeks,8weeks,12weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The side effects of Adapalene and Benzoyl peroxide will be assessed |
Baseline,4weeks,8weeks,12weeks |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
30/04/2021 |
| Date of Study Completion (India) |
30/03/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
WILL BE PUBLISHED |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
After obtaining approval from the Institutional Ethics Committee, the study will be conducted in the Department of Dermatology, Sree Balaji Medical college & Hospital, Chrompet, Chennai. Patients coming to Department of Dermatology, SBMCH with the history of acne will be subjected to thorough dermatological examination. Based on Indian clinical scoring system the diagnosis of mild to moderate acne vulgaris will be made. The patients who fulfil inclusion criteria will be recruited in the study. Informed consent will be obtained after explaining the risks and benefits in the treatment of acne vulgaris Patients will be assessed at Baseline, 4 weeks, 8 weeks, 12weeks to assess the efficacy based on lesion reduction. The Patients will be divided into two groups Group 1: Patients taking topical adapalene gel 0.1%; Sample size: 50 Group 2: Patients taking topical benzoyl peroxide gel 2.5%; Sample size: 50 This study will be registered with Clinical Trials Registry of India |