| CTRI Number |
CTRI/2024/12/077692 [Registered on: 05/12/2024] Trial Registered Prospectively |
| Last Modified On: |
27/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare the efficacy and safety of topical trifarotene cream versus adapalene gel in mild to moderate acne vulgaris |
|
Scientific Title of Study
|
A randomized control trial to compare the efficacy and safety of topical trifarotene 0.005 percent cream versus adapalene 0.1 percent gel in mild to 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 E Sushnitha Johnson |
| Designation |
Junior resident |
| Affiliation |
Jawaharlal Nehru Medical College Belagavi-590010, Karnataka. |
| Address |
Department of Dermatology, Venereology and Leprosy,
Jawaharlal Nehru Medical College
Belagavi-590010, Karnataka.
Belgaum
KARNATAKA
590010
India |
| Phone |
9585222974 |
| Fax |
|
| Email |
sushnitha910@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SHARADA VEERANNA GOUDAGAON |
| Designation |
Assistant professor |
| Affiliation |
Jawaharlal Nehru Medical College, Belgaum |
| Address |
Department of Dermatology, Venereology and Leprosy,
Jawaharlal Nehru Medical College
Belagavi-590010, Karnataka.
Belgaum
KARNATAKA
590010
India |
| Phone |
8971670453 |
| Fax |
|
| Email |
sharada24101992@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr E Sushnitha Johnson |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Nehru Medical College, Belgaum |
| Address |
Department of Dermatology, Venereology and Leprosy,
Jawaharlal Nehru Medical College
Belagavi-590010, Karnataka.
Belgaum
KARNATAKA
590010
India |
| Phone |
9585222974 |
| Fax |
|
| Email |
sushnitha910@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr E Sushnitha Johnson |
| Address |
Department of Dermatology, Venereology and Leprosy,
Jawaharlal Nehru Medical College
Belagavi-590010, Karnataka.
|
| 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 E Sushnitha Johnson |
KLEs Dr Prabhakar Kore hospital |
Opd no 23, 1st floor Dept of Dermatology Venerology and Leprosy, Jawaharlal Nehru Medical College
Belgaum
KARNATAKA |
9585222974
sushnitha910@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NMC Institutional ethics committee |
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 |
topical cream |
Topical creams will be applied topically daily once a day for 12 weeks . Results will then be compared with baseline. |
| Comparator Agent |
Topical cream- Adapalene (group A) |
Patients of Group A will be asked to apply adapalene 0.1% gel once daily for 12 weeks. Both the groups will be provided with skin care products including identical gentle non-comedogenic cleanser, moisturizer and sunscreen.Digital photographs of the face and trunk will be taken using identical camera settings, patient positioning and room lighting at baseline and at 12 weeks then compared
|
| Comparator Agent |
Topical cream- Trifarotene (group B) |
Patients of Group B will be asked to apply trifarotene 0.005% cream once daily for 12 weeks. Both the groups will be provided with skin care products including identical gentle non-comedogenic cleanser, moisturizer and sunscreen.Digital photographs of the face and trunk will be taken using identical camera settings, patient positioning and room lighting at baseline and at 12 weeks then compared.
|
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.All patients aged from 10 to 50 years with active acne willing to come for regular follow up
2.No history of topical treatments for two weeks, dermatologic procedures such as laser therapy, deep chemical peeling for four weeks, systemic medications like corticosteroids, antibiotics, or spironolactone for four weeks; and 12 weeks for oral retinoids/isotretinoin, cyproterone acetate, and immunomodulators when enrolled in the study
3.Patients with facial and truncal acne defined by Investigator’s Global Assessment (IGA) score of 1 to 3 (mild to moderate)
|
|
| ExclusionCriteria |
| Details |
1.Patients with facial and truncal acne defined by Investigator’s Global Assessment (IGA) score of 4 (severe)
2.Acne conglobates, acne fulminans, secondary acne, drug induced acne, nodulocystic acne, or acne requiring systemic treatment
3.≥ 3 excoriated lesions
4.Pregnant or lactating women or plan to conceive during study period
5.Known or suspected allergies to study drugs
6.Any concomitant skin conditions over the face
7.Immunosuppressed patients
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of topical trifarotene 0.005% cream versus adapalene 0.1% gel in mild to moderate acne vulgaris. |
one year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the safety profile of topical trifarotene 0.005% cream versus adapalene 0.1% gel in mild to moderate acne vulgaris. |
one year |
|
|
Target Sample Size
|
Total Sample Size="126"
Sample Size from India="126"
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 2 |
|
Date of First Enrollment (India)
|
15/01/2025 |
| 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 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
|
· After screening, all patients with active acne (comedones, papules and pustules) will be chosen. · Before starting treatment, detailed history, clinical examination of patients will be done. · The patient will be informed about the treatment given and possible local side effects like dryness, erythema and irritation which might occur. · Informed written consent will be taken from each patient · In case of minor patients, the informed written consent will be taken from the parent/guardian · Data will be collected by a single examiner and recorded in case proforma. · Patients will be randomly divided into two equal groups, Group A and Group B · Patients of Group A will be asked to apply adapalene 0.1% gel once daily for 12 weeks · Patients of Group B will be asked to apply trifarotene 0.005% cream once daily for 12 weeks · Both the groups will be provided with skin care products including identical gentle non-comedogenic cleanser, moisturizer and sunscreen · Digital photographs of the face and trunk will be taken using identical camera settings, patient positioning and room lighting at baseline and at 12 weeks. · After 12 weeks, the digital photographs will be compared with baseline. · Physician’s assessment of improvement will also be recorded by Investigator’s Global Assessment (IGA) score for facial and truncal acne · The efficacy of the treatment will be calculated based on percent of clearance of lesions · The safety of the treatment will be assessed by the side effects associated with the treatment · Patient’s assessment of improvement will be recorded by visual analog scale. |