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CTRI Number  CTRI/2025/03/082816 [Registered on: 19/03/2025] Trial Registered Prospectively
Last Modified On: 18/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Medical Device
Other (Specify) [TOPICAL TRETINOIN GEL AND FRACTIONAL CARBONDIOXIDE LASER]  
Study Design  Other 
Public Title of Study   To compare the treatment of stretch marks using laser(fractional CO2 laser) and topical therapy (tretinoin 0.05 percent gel)in Indian skintype. 
Scientific Title of Study   Efficacy of Fractional Carbon Dioxide Laser versus topical Tretinoin 0.05 percent gel in the treatment of striae distensae in Indian skin phototypes: A comparative, split-abdomen study. 
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 VEENA V T 
Designation  POST-DOCTORAL FELLOWSHIP IN DERMATOSURGERY 
Affiliation  CHRISTIAN MEDICAL COLLEGE, VELLORE, TAMIL NADU 
Address  POST DOCTORAL FELLOWSHIP IN DERMATOSURGERY, DVL-2, #157, CMC ANNEX, SATHVACHARI, CHRITIAN MEDICAL COLLEGE VELLORE, TAMIL NADU, 632004

Vellore
TAMIL NADU
632004
India 
Phone  8105148298  
Fax    
Email  veena.v@cmcvellore.ac.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr DINCY PETER C V 
Designation  Senior Professor, Head Of The Department Of Dermatology. 
Affiliation  CHRISTIAN MEDICAL COLLEGE, VELLORE, TAMIL NADU 
Address  Room no-257, DVL-2, Ida Scudder road, Chrisitian Medical College, Vellore district, TAMIL NADU STATE, 632004

Vellore
TAMIL NADU
632004
India 
Phone  9894350434  
Fax    
Email  dincy.peter@cmcvellore.ac.in  
 
Details of Contact Person
Public Query
 
Name  Dr VEENA V T 
Designation  MBBS., MD IN DERMATOLOGY VENEREOLOGY AND LEPRSOY 
Affiliation  CHRISTIAN MEDICAL COLLEGE, VELLORE, TAMIL NADU 
Address  POST GRADUATE FELLOWSHIP IN DERMATOSURGERY, DVL-2, #157, CMC ANNEX, SATHVACHARI, CHRITIAN MEDICAL COLLEGE VELLORE, TAMIL NADU, 632004

Vellore
TAMIL NADU
632004
India 
Phone  8105148298  
Fax    
Email  veena.v@cmcvellore.ac.in  
 
Source of Monetary or Material Support  
christian medical college, vellore district,Tamil nadu state, India pin code 632002 
 
Primary Sponsor  
Name  Christian Medical College vellore District Tamil Nadu State India pincode  
Address  Chrstian Medical College, Vellore, District, Tamil Nadu State, pin code -632002 
Type of Sponsor  Research institution and hospital 
 
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 Veena V T  Christian Medical College , vellore district  Ida Scudder , OPD Block, second floor ROOM NO-257, Dermatology Venereology Leprosy unit II, CMC vellore, Tamil Nadu state pincode-632004
Vellore
TAMIL NADU 
08105148298

veena.v@cmcvellore.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional review board, cmc vellore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L989||Disorder of the skin and subcutaneous tissue, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  fractional CO2 Laser in treatment of stretch marks   abdomen is divided into two halfs , where the area to be treated with fractional co2 laser wll be selected by chit method.Total 3 sessions of laser will be planned 1 month apart and final assessment will be done after a month of last laser sessions by Global aiesthetic improvement scale, Patient satisfaction score and dermoscopy assesment . 
Comparator Agent  topical tretinoin 0.05 gel   7 months of trial 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  aged above 18 years and above and willing for participate in the study 
 
ExclusionCriteria 
Details  Pregnant or lactating women.
Patients with severe cardiac, brain, liver or kidney failure, Malnutrition.
Patients who have been treated in the previous 6 months with lasers or chemical peels.
Patients with active infection.
History of keloid formation.
Patients with autoimmune diseases, Cushing’s syndrome and polycystic ovary syndrome.
History of systemic steroid treatment, systemic retinoid therapy.
Unable to visit for regular treatment sessions.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Other 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Comparison of pictures for changes in the appearance and also width by dermoscopy assessment at 0 and 16 week .
 
Assessments will be done by comparing at 0 week and at the end of 16 week of the study 
 
Secondary Outcome  
Outcome  TimePoints 
change in appearance of stretch marks  at baseline after 4 weeks at 8 weeks & final assessment is at 16 weeks  
 
Target Sample Size   Total Sample Size="53"
Sample Size from India="53" 
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)   29/03/2025 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [veena.v@cmcvellore.ac.in].

  6. For how long will this data be available start date provided 24-03-2025 and end date provided 23-04-2026?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  

Striae distensae (SD) or stretch marks are linear atrophic dermal scars covered with flat atrophic epidermis. This study aims at comparing the efficacy and safety of Fractional CO2 laser alone and in combination with topical Tretinoin 0.05% gel in the treatment of striae distensae in skin of colour Fitzpatrick skin phototypes III, IV, V and VI.

As, there are not many studies that compares fractional CO2 laser versus topical tretinoin 0.05% gel for striae distensae in Indian skin types, our study will be usefull in comparing the efficacy of both these modalities in the treatment of striae distensae.

 

All patients with SD visting our Dermatology, Venereology and Leprosy/Cosmetic Dermatology OPD seeking treatment for the same will be enrolled in our study after informed consent. Patients will be examined and extent of striae will be assessed. In patients having multiple sites of involvement, the site of maximum cosmetic concern over the abdomen  will be selected for intervention. Abdomen will be divided into two halfs keeping the longitudinal midline as the center. The lesions on the side to be treated  with Fractional CO2 laser will be randomly selected by using a chit method. The other side will be treated with topical tretinoin 0.05 % gel. The Tretinoin gel will be continued on a daily basis at night. A total of three laser sessions will be done with an interval of 1 month duration. Post procedure white soft paraffin will be recommended for daily application in the morning over the sites of treatment.  Patients will be assessed immediately post treatment for any redness, burning, pain or discomfort. They will also be followed up in the subsequent visits for any untoward complications like post inflammatory hyperpigmentation, infection, persistent erythema, ulcers, scarring and keloid formation. Photographs will be taken at baseline, before each session and at the end of 1 month after the last session. 

In our study, the Global aesthetic improvement scale will be used for comparing the photographs at baseline with the final photographs 1 month after the last laser session by a single investigator. The patient satisfaction scores will be done 1 month after the last laser procedure. The width of the striae will also be assessed using dermoscopy prior to initiation of treatment and at 1 month after the last session.

 

 

 
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