FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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 baselineThe 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.


 
Close