| CTRI Number |
CTRI/2025/07/090186 [Registered on: 04/07/2025] Trial Registered Prospectively |
| Last Modified On: |
02/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
THE STUDY OF EFFECTIVENESS AND SAFETY OF TRIFAROTENE 0.005% AND ADAPALENE 0.1% IN TREATMENT OF ACNE
|
|
Scientific Title of Study
|
A RANDOMISED CONTROL TRIAL TO EVALUATE THE EFFECTIVENESS AND SAFETY OF TRIFAROTENE 0.005% AND ADAPALENE 0.1% IN TREATMENT OF MILD AND MODERATE 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 Kallepu Rishika Sagar |
| Designation |
Postgraduate (MD DERMATOLOGY VENEREOLOGY LEPROSY ) |
| Affiliation |
S.R.M medical college hospital and research centre |
| Address |
Room no 35, b block, 2nd floor dept of dermatology venereology and leprosy, Srm University, Kattankulathur
Chengalpattu
Nandivaram Guduvancheri, TAMIL NADU 603203
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
7032320388 |
| Fax |
|
| Email |
rishikasagark7597@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. MURALI NARASIMHAN |
| Designation |
Professor and hod of dermatology venereology and leprosy |
| Affiliation |
S.R.M UNIVERSITY |
| Address |
Room no 35, 2nd floor, b block, dept of DVL, Srm medical college hospital , Kattankulathur
Chengalpattu
Nandivaram Guduvancheri, TAMIL NADU 603203
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
7032320388 |
| Fax |
|
| Email |
hod.dermat.ktr.med@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kallepu Rishika Sagar |
| Designation |
Postgraduate ( MD DERMATOLOGY VENEREOLOGY LEPROSY) |
| Affiliation |
S.R.M medical college hospital and research centre |
| Address |
Room no 35, b block, 2nd floor, Srm medical college hospital , Kattankulathur
Chengalpattu
Nandivaram Guduvancheri, TAMIL NADU 603203
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
7032320388 |
| Fax |
|
| Email |
rishikasagark7597@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [Nil] |
|
|
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 Kallepu Rishika Sagar |
SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
Hospital block, 2nd floor, department of dermatology venereology and leprosy, SRM medical college hospital and research centre, Kattankulathur, Kancheepuram, Tamil Nadu.
Kancheepuram
TAMIL NADU |
7032320388
rishikasagark7597@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: L00-L99||Diseases of the skin and subcutaneous tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Adapalene 0.1% |
Adapalene 0.1% gel,, a pea size quantity should be taken and apply over entire face initially over 2 hrs , if no irritation 5 hrs and followed by overnight for 12 weeks. |
| Intervention |
Trifarotene 0.005% |
Trifarotene 0.005% cream, a pea size quantity should be taken and apply over entire face initially over 2 hrs , if no irritation 5 hrs and followed by overnight for 12 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Patients attending SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE Dermatology OPD and diagnosed with Acne Vulgaris.
Patients willing to take topical medication for Acne vulgaris.
Patients providing voluntary informed and written consent for the explained treatment modality .
Patient age 18 years and older.
Patient of either sex with mild and moderate facial acne according to IGA score (Investigators global assessment ) score and GAGS ( Global Acne Grading System). |
|
| ExclusionCriteria |
| Details |
Severe form of acne
Greater than one nodule on the face
Presence of acne cysts, excessive beard, facial hair that could interfere with study assessments.
Known or suspected allergies or sensitivities to the planned study drug.
Intent to conceive during the study in women .
Lactating mothers during the study
Patients who have not given written consent for participation in study
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction of acne |
4 weeks - reduction of comedones along with redness
8 weeks- reduction of comedones along with pustules
12 weeks- reduction of comedones, pustules, redness and decrease in recurrence of acne. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction of acne scars, improvement of texture |
4 weeks - improvement in erythema
8 weeks- improvement in texture
12 weeks- overall improvement in texture & acne scars |
|
|
Target Sample Size
|
Total Sample Size="118"
Sample Size from India="118"
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)
|
15/07/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
A total of 118 above 18 years after excluding using exclusion criteria mild to moderate acne vulgaris patients are divided into 2 groups with 59 in each. Group A- TRIFAROTENE 0.005 percentage is given for 12 weeks and group B- ADAPALENE 0.1 percentage is given for 12 weeks. Patient are asked to visit at 0,4,8,12 weeks . At each visit acne is assessed using parameters like investigators global assessment IGA score and global acne grading system GAGS and photographs are taken at each visit. The expected benefits that is efficacy are reduction in acne , post inflammatory hyperpigmentation, improvement in texture and contour of the skin which is assessed with counting the no.of open, closed comedones, papules, pustules along with photographs taken during each visit. The adverse effects like erythema, burning, dryness, itching, peeling of the skin is also assessed which accounts for the safety party of the drug. |