| CTRI Number |
CTRI/2025/10/096476 [Registered on: 27/10/2025] Trial Registered Prospectively |
| Last Modified On: |
24/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Topical cream ] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effectiveness of a Natural Cream (STRETCH MARKS B GONE) in Reducing Stretch Marks |
|
Scientific Title of Study
|
An Open-Label Exploratory Study on the Efficacy of a Multi-Ingredient Natural Topical Formulation STRETCH MARKS B GONE for the Management of Stretch Marks (Striae Distensae) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CTS/25/25, Version: 1.0, Date: 05-10-2025 |
Protocol Number |
| Secondary ID |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Roshany |
| Designation |
Consultant |
| Affiliation |
DK Elite Health Care Centre |
| Address |
Room No 1, Department of Dermatologist, First Floor, 370, Cuddalore Main Road, Nainarmandabam, Puducherry
Pondicherry
PONDICHERRY
605004
India |
| Phone |
09943805988 |
| Fax |
|
| Email |
roshanysakthibalan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sakthi Balan |
| Designation |
Consultant |
| Affiliation |
DK Elite Health Care Centre |
| Address |
Room No 1, department of Pharmacology, First Floor, 370, Cuddalore Road, Nainar Mandapam, Velrampet, Puducherry, 605004
Pondicherry
PONDICHERRY
605004
India |
| Phone |
09843591097 |
| Fax |
|
| Email |
saheerose@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gayathri Sivakumar |
| Designation |
Director |
| Affiliation |
KI3 PRIVATE LIMITED |
| Address |
Room no 1, Clinical trial department, No 5 3, Dr Jayalakshmi Street, Radha Nagar, Chrompet, Chennai
Chennai
TAMIL NADU
600 044
India |
| Phone |
09003109416 |
| Fax |
|
| Email |
drgayathri@ki3services.com |
|
|
Source of Monetary or Material Support
|
| Dermesse Raw and Naturals Private Limited., India |
|
|
Primary Sponsor
|
| Name |
Dermesse Raw and Naturals Private Limited., India |
| Address |
V35, V Block 14th Street Anna Nagar (Chennai) Chennai Tamil Nadu India 600040 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Roshany |
DK Elite Health Care Centre |
Room No 1, Department of Dermatologist, First Floor, 370, Cuddalore Main Road, Nainarmandabam, Puducherry
Pondicherry
PONDICHERRY |
09943805988
roshanysakthibalan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHIQUE DE LA NATURE ASSOCIATION |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L906||Striae atrophicae, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NA |
NA |
| Intervention |
Stretch Marks B Gone |
Beeswax,Shea butter,Coconut oil,Moringa Oil,Jojoba oil, Almond oil,Evening Primrose oil,Vit E oil and Frankinsence oil
Study duration - 4 weeks each participant |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Adults 18–45 years.
2. Visible stretch marks (striae rubra or alba) on belly/hips/thighs/knees and shoulders, present
Greater than or equal to 3 months to 1 years due to change in the body weight, Post Partum Changes.
3. Willing to refrain from other topical treatments/procedures on test areas during the study.
4. Able to comply and sign informed consent.
|
|
| ExclusionCriteria |
| Details |
1. Pregnant or breastfeeding.
2. Known allergy to any ingredient of test product.
3. Recent Greater than or equal to 3 topical retinoid, steroid, or procedural treatment on target areas.
4. Active dermatitis or infection in test area.
5. Participation in another clinical study within 30 days. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Mean change from baseline, Week 2 and Week 4 in photo
graded Visual Improvement Scale (VIS) and or percent change
in stretch-marks. (For those who give consent) |
Baseline (Day 0), Visit 2 (week 2), Visit 3 (28 days) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Skin texture: Mean percentage improvement - baseline and Week 4 (target: approx 25 percent improvement). Report mean ± SD and CI.
(instrument plus Self-assessment)
2. Dryness or tightness: Proportion of participants demonstrating self-perceived improvement and an increase in skin hydration as measured by a corneometer at baseline and Week 4.
3. Elasticity (Cutometer): Mean percentage change in R2 at Week 4
(target approx 15 percent) Baseline & week 4
4. VAS – Tightness, dryness, and itching (0–10) – Baseline, Week 2 and Week 4
5. 5-point Likert for agreement with statements (e.g.,
elastic or comfortable). Week 4
6. DLQI – Dermatology Life Quality Index (Baseline and week 4)
7. Safety: number and percentage of subjects with local irritation or other
AEs. |
Baseline (Day 0), Visit 2 (week 2), Visit 3 (28 days) |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
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 3 |
|
Date of First Enrollment (India)
|
06/11/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
06/11/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
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
|
This open-label exploratory study will evaluate the efficacy and safety of a natural topical formulation, STRETCH MARKS B GONE, for improving stretch marks (striae distensae).Inclusion and Exclusion Criteria:Twenty-five adults (20 females, 5 males) aged 18–45 years with visible stretch marks on the abdomen, hips, thighs, knees, or shoulders for at least 3 months to 1 year due to weight changes or postpartum effects will be enrolled. Participants will apply the product twice daily for 4 weeks.
The primary objective is to assess changes in stretch-mark appearance using photographic and morphometric analysis.
Secondary objectives include evaluation of skin hydration, elasticity, and patient-reported outcomes on dryness, itching, and comfort. Assessments will be performed at baseline, Week 2, and Week 4 to confirm visible improvement and product safety. |