| CTRI Number |
CTRI/2025/08/093316 [Registered on: 20/08/2025] Trial Registered Prospectively |
| Last Modified On: |
19/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
How Well a Three-in-One Acne Gel Works to Clear Pimples |
|
Scientific Title of Study
|
Clinical efficacy of topical fixed dose triple combination of Clindamycin Phosphate, Adapalene and Benzoyl Peroxide in acne vulgaris |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Harjot Singh |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
Government medical college and hospital ,chandigarh |
| Address |
DEPARTMENT OF DERMATOLOGY, VENEREOLOGY AND LEPROSY. D BLOCK 5TH FLOOR, GMCH32, CHANDIGARH
Chandigarh
CHANDIGARH
160047
India |
| Phone |
9888602331 |
| Fax |
|
| Email |
harjot.singh2331@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mala Bhalla |
| Designation |
PROFESSOR |
| Affiliation |
Government medical college and hospital ,chandigarh |
| Address |
DEPARTMENT OF DERMATOLOGY , VENEREOLOGY AND LEPROSY ,D BLOCK 5TH FLOOR, GMCH32, CHANDIGARH
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646121545 |
| Fax |
|
| Email |
malabhalla@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Harjot Singh |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
Government medical college and hospital ,chandigarh |
| Address |
DEPARTMENT OF DERMATOLOGY VENEREOLOGY AND LEPROSY ,D BLOCK 5TH FLOOR,, GMCH32, CHANDIGARH
Chandigarh
CHANDIGARH
160047
India |
| Phone |
09888602331 |
| Fax |
|
| Email |
harjot.singh2331@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Medical College and Hospital ,sector 32 , Chandigarh,160030,India |
|
|
Primary Sponsor
|
| Name |
Dr Harjot Singh |
| Address |
DEPARTMENT OF DERMATOLOGY, VENEREOLOGY AND LEPROSY. D BLOCK 5TH FLOOR, GMCH SECTOR 32 ,CHANDIGARH,160032,INDIA |
| 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 |
| Dr Harjot Singh |
GOVERNMENT MEDICAL COLLEGE AND HOSPITAL ,SECTOR 32,CHANDIGARH |
DEPARTMENT OF DERMATOLOGY,VENEREOLOGY AND LEPROSY, D BLOCK , 5TH FLOOR CHANDIGARH
Chandigarh
CHANDIGARH |
09888602331
harjot.singh2331@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE(GMCH, Chandigarh) |
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 |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Topical fixed-dose triple combination gel of Clindamycin Phosphate (1.2%), Adapalene (0.15%), and Benzoyl Peroxide (3.1%)
|
This study aims to determine the efficacy of fixed dose triple combination of topical Clindamycin Phosphate 1.2%, Adapalene 0.15%, Benzoyl Peroxide 3.1 % gel in Acne Vulgaris The study will be Prospective, Open label, Single arm interventional study and will be conducted over 18 months at GMCH Chandigarh.
50 patients will be recruited in this study. Patients of acne vulgaris (Grade 1 and Grade 2) and of 12-50 years age will be included in this study. Participants will be instructed to cleanse the facial skin using non medicated gentle soap and water and subsequently apply the designated topical formulation to the affected areas at bedtime. They will be instructed to avoid applying cosmetics, moisturizers, or any other topical treatments on their face.
Clinical evaluation and photographic assessment will be done at baseline first visit and at each follow up visit (3,6,9,12 weeks). The therapeutic response will be evaluated objectively by assessing the total lesion count and calculating the percentage reduction from baseline values. Monitoring and categorization of adverse events will also be done in this study.
A triple drug combination may enhance therapeutic outcomes by acting upon multiple acne-related mechanisms simultaneously and by increasing the compliance of treatment.
|
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients of acne vulgaris (Grade 1 and Grade 2) 2)Patients of 12-50 years age
|
|
| ExclusionCriteria |
| Details |
•Pregnant or lactating women
•Patients with signs and symptoms of hyperandrogenism
•Patients having hypothyroidism or any other serious systemic illness
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Percentage improvement and reduction in the total lesion count from baseline, and reduction in total lesion count assessed through clinical photography
|
Assessment will be done at baseline visit (week 0), 3 weeks ,6 weeks , 9 weeks , 12 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Patient-reported outcomes: Evaluation of treatment satisfaction and improvement in acne.
2. Adverse effects: Monitoring and categorization of adverse events in triple combination therapy.
|
Baseline (Week 0) – Before starting treatment
Week 3 – First follow-up
Week 6 – Second follow-up
Week 9 – Third follow-up
Week 12 – Final follow-up/end of study |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
02/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="11"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study aims to
determine the efficacy of fixed dose triple combination of topical Clindamycin
Phosphate 1.2%, Adapalene 0.15%, Benzoyl Peroxide 3.1 % gel in Acne Vulgaris
The study will be Prospective, Open label, Single arm interventional study and will be conducted over 18 months at GMCH Chandigarh.
50 patients
will be recruited in this study. Patients of acne vulgaris (Grade 1 and Grade 2) and of 12-50 years age will be
included in this study. Participants will be instructed to cleanse the facial
skin using non medicated gentle soap and water and subsequently apply the
designated topical formulation to the affected areas at bedtime. They will be instructed to avoid applying cosmetics,
moisturizers, or any other topical treatments on their face.
Clinical evaluation and photographic assessment
will be done at baseline first visit and at each follow up visit (3,6,9,12
weeks). The therapeutic response will be evaluated
objectively by assessing the total lesion count and calculating the percentage
reduction from baseline values. Monitoring and categorization of adverse events
will also be done in this study.
A triple drug combination may enhance therapeutic
outcomes by acting upon multiple acne-related mechanisms simultaneously and by
increasing the compliance of treatment. |