| CTRI Number |
CTRI/2024/12/078197 [Registered on: 16/12/2024] Trial Registered Prospectively |
| Last Modified On: |
11/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of efficacy of topical Trifarotene and Tretinoin in acne vulgaris |
|
Scientific Title of Study
|
Comparitive efficacy of topical Trifarotene and Tretinoin 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 Mala Bhalla |
| Designation |
Professor ( Dermatology ) |
| Affiliation |
Government Medical College and Hospital Chandigarh |
| Address |
Department of Dermatology Venereology and Leprology Government Medical College and Hospital sector 32 Chandigarh
Chandigarh CHANDIGARH 160030 India |
| Phone |
9646121545 |
| Fax |
|
| Email |
malabhalla@yahoo.co.in |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Mala Bhalla |
| Designation |
Professor ( Dermatology ) |
| Affiliation |
Government Medical College and Hospital Chandigarh |
| Address |
Department of Dermatology Venereology and Leprology Government Medical College and Hospital sector 32 Chandigarh
Chandigarh CHANDIGARH 160030 India |
| Phone |
9646121545 |
| Fax |
|
| Email |
malabhalla@yahoo.co.in |
|
Details of Contact Person Public Query
|
| Name |
Dr. Mala Bhalla |
| Designation |
Professor ( Dermatology ) |
| Affiliation |
Government Medical College and Hospital Chandigarh |
| Address |
Department of Dermatology Venereology and Leprology Government Medical College and Hospital sector 32 Chandigarh
Chandigarh CHANDIGARH 160030 India |
| Phone |
9646121545 |
| Fax |
|
| Email |
malabhalla@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| INFRASTRUCTURAL SUPPORT Government Medical College and Hospital sector 32 Chandigarh 160030 India |
|
|
Primary Sponsor
|
| Name |
Government Medical College and Hospital Chandigarh |
| Address |
Government Medical College and Hospital sector 32 Chandigarh India 160030 |
| Type of Sponsor |
Government medical college |
|
|
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 Lavanya Rishi |
Government Medical College and Hospital Chandigarh |
Dermatology OPD B Block 4th Floor Chandigarh CHANDIGARH |
9888889526
drlavanyarishi@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 |
Tretinoin 0.025 percent cream |
Patients will be asked to apply topical tretinoin 0.025 percent cream local application over the affected areas of face at bedtime for a total duration of 12 weeks |
| Intervention |
Trifarotene 0.005 percent cream |
Patient will be asked to apply topical trifarotene 0.005 percent cream local application over the affected areas of the face at bedtime for a total duration of 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients of acne vulgaris (grade 1 & 2)involving face and not requiring systemic therapy
2.Patients of 16-50 years of age. |
|
| ExclusionCriteria |
| Details |
1.Pregnant and lactating mothers
2.Patients with severe systemic illness requiring systemic therapy of more than 4 weeks
3.Patients with signs and symptoms of hyperandrogenism
4.Patients with truncal acne |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Percentage improvement and reduction in the total lesion count from the baseline
2.Reduction in total lesion count assessed through clinical photography |
At Baseline,3 weeks,6 weeks,9 weeks and 12 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Patient-reported outcomes: Evaluation of treatment satisfaction & improvement in acne.
2.Adverse effects: Monitoring & categorization of adverse events related to each treatment using the Numeric Rating Scale .
|
At baseline,3 weeks,6 weeks,9 weeks & 12 weeks.
|
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
26/12/2024 |
| 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
|
Patients of clinically diagnosed acne vulgaris attending the Out Patient Department of Dermatology ,GMCH Chandigarh will be recruited for the study after written informed consent into 2 groups of 25 each. Group 1-Pateints receiving topical tretinoin 0.025% cream Local application at night Group 2-Patients receiving topical trifarotene 0.005% cream Local application at night
Clinical
evaluation and photographic assessment will be done at baseline (first visit) and
at each follow up visit (3, 6, 9 and 12 weeks). Response of the therapy will be measured by the objective
measure of total lesion count and percentage reduction compared from baseline. The improvement
will be graded as below:
Nil: 0-25% reduction in lesions
Mild: 26-50% reduction in lesions
Moderate: 51-75% reduction in lesions
Good: 76-100% reduction in lesions
Patients will be informed about the likely side effects of topical
retinoids such as dryness, erythema, skin irritation,
skin peeling, itching, stinging, exacerbation of lesions etc and will be
asked to note, grade and report these to the treating physician. Adverse
effects reported by participants will be categorized according to the Numeric
Rating Scale (NRS) in which each adverse effect will be assigned a numerical
score ranging from 0 to 10, with 0 representing no side effect and 10
representing an extremely severe side effect. If exacerbation, in
terms of inflammatory nodular predominant lesions, or if unwilling for further
continuation, the patients shall be excluded from the study and managed with
alternative therapies requiring systemic antibiotics or retinoids. In case the patients
complain of excessive dryness (Numeric Rating Scale 7 or more), they will be
asked to stop the medication for three days, restart and if dryness persists or
increases, patients shall be taken out of the study. Owing to increased
photosensitivity after the use of topical retinoids, the patients shall be
advised for strict photoprotection both by the use of non comedogenic sunscreen
as well as physical protection.
|