| 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
|
|
|
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
|
|
|
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
- 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).
- 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
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [veena.v@cmcvellore.ac.in].
- 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.
- 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. |