| CTRI Number |
CTRI/2025/12/098641 [Registered on: 08/12/2025] Trial Registered Prospectively |
| Last Modified On: |
06/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Medical Device |
| Study Design |
Other |
|
Public Title of Study
|
Comparative study of microneedling with human placental extract vs microneedling with platelet-rich plasma for the treatment of stretch marks |
|
Scientific Title of Study
|
Comparative Study of Microneedling with Human Placental Extract vs Microneedling with Platelet-Rich Plasma for the Treatment of Stretch Marks (Striae Distensae) |
| 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 Mansi Sunil Chavan |
| Designation |
Junior Resident , Department of Dermatology , Venereology and Leprosy |
| Affiliation |
KLE Academy of Higher Education and Research , Deemed to be University , Belagavi |
| Address |
Room No.28 , Gangambika Ladies PG Hostel , JNMC Campus , Nehru Nagar , Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
8088622957 |
| Fax |
|
| Email |
mansichavan105@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhavana R Doshi |
| Designation |
Professor And Head, Department Dermatology , Venereology And Leprosy |
| Affiliation |
KLE Academy of Higher Education and Research , Deemed-to-be-University , Belagavi |
| Address |
Department Dermatology , Venereology And Leprosy
Jawaharlal Nehru Medical College , Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9422306523 |
| Fax |
|
| Email |
bhavs1982@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mansi Sunil Chavan |
| Designation |
Junior Resident , Department of Dermatology , Venereology and Leprosy |
| Affiliation |
KLE Academy of Higher Education and Research , Deemed to be University , Belagavi |
| Address |
Room No.28 , Gangambika Ladies PG Hostel , JNMC Campus , Nehru Nagar , Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
8088622957 |
| Fax |
|
| Email |
mansichavan105@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dermatology, Venereology And Leprosy OPD, KLES Dr.Prabhakar Kore Hospital and Medical Research Centre, Belagavi |
|
|
Primary Sponsor
|
| Name |
Dr.Mansi Sunil Chavan |
| Address |
Room No.28 , Gangambika Ladies Pg Hostel , JNMC Campus , Nehru Nagar , Belagavi – 590010 |
| Type of Sponsor |
Other [SELF] |
|
|
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 |
| DrMansi Sunil Chavan |
KLEs Dr.Prabhakar Kore Hospital and Medical Research Centre, Belagavi |
KLEs Dr.Prabhakar Kore Hospital and Medical Research Centre, Belagavi , Dermatology OPD no 23 ,First floor , Room no.2
Belgaum
KARNATAKA |
8088622957
mansichavan105@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L905||Scar conditions and fibrosis of skin, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
A split face comparative intervention on human placental extract vs platelet rich plasma |
The study protocol is designed to allow direct intra-individual comparison between two modalities for the treatment of stretch marks (striae distensae) using a split-face interventional model. Each subject’s abdomen (or selected site with comparable lesions) will be divided along the midline in the sagittal plane to create a split-face model. Although randomization is not performed in the split-face design, the CONSORT structure ensures methodological transparency and adherence to clinical trial reporting standards. Screening and Enrollment Phase: Participants will be enrolled as they present to the outpatient department after fulfilling the inclusion and exclusion criteria and providing informed consent. Intervention Phase (Microneedling + Topical application of Human Placental Extract formulation / Microneedling with PRP sessions): Session 1 at Week 0, Session 2 at Week 4, and Session 3 at Week 8. Follow-up and Final Assessment Phase: Final evaluation will be performed at Week 12 following the third session. |
| Comparator Agent |
Human Placental Extract |
The study protocol is designed to allow direct intra-individual comparison between two modalities for the treatment of stretch marks (striae distensae) using a split-face interventional model. Each subject’s abdomen (or selected site with comparable lesions) will be divided along the midline in the sagittal plane to create a split-face model. Although randomization is not performed in the split-face design, the CONSORT structure ensures methodological transparency and adherence to clinical trial reporting standards. Screening and Enrollment Phase: Participants will be enrolled as they present to the outpatient department after fulfilling the inclusion and exclusion criteria and providing informed consent. Intervention Phase (Microneedling + Topical application of Human Placental Extract formulation / Microneedling with PRP sessions): Session 1 at Week 0, Session 2 at Week 4, and Session 3 at Week 8. Follow-up and Final Assessment Phase: Final evaluation will be performed at Week 12 following the third session. |
| Comparator Agent |
Platelet Rich Plasma |
The study protocol is designed to allow direct intra-individual comparison between two modalities for the treatment of stretch marks (striae distensae) using a split-face interventional model. Each subject’s abdomen (or selected site with comparable lesions) will be divided along the midline in the sagittal plane to create a split-face model. Although randomization is not performed in the split-face design, the CONSORT structure ensures methodological transparency and adherence to clinical trial reporting standards. Screening and Enrollment Phase: Participants will be enrolled as they present to the outpatient department after fulfilling the inclusion and exclusion criteria and providing informed consent. Intervention Phase (Microneedling + Topical application of Human Placental Extract formulation / Microneedling with PRP sessions): Session 1 at Week 0, Session 2 at Week 4, and Session 3 at Week 8. Follow-up and Final Assessment Phase: Final evaluation will be performed at Week 12 following the third session. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
All patients of striae distensae who are
1) Age group between 18 and 40 years
2) Striae due to all the physiological causes- rapid weight gain/loss, pregnancy induced in non-pregnant women etc.
3) Striae alba
|
|
| ExclusionCriteria |
| Details |
1) Patients between the age of 18 - 40 years of age
2) Striae due to bleeding disorders, autoimmune disorders , renal failure, chronic liver disease, any inflammation or wound , topical or systemic steroid use
3) History of keloid scarring
4)Pregnant and lactating women
5)Patient on blood thinners or immunosuppressants
6)Diabetic Patients
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in scar score (before and after treatment) and appearance |
Week 0 , Week 4 , Week 8 , Week 12 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Patient satisfaction score / global assessment scale : Using a Visual Analogue Scale (VAS)
Surface area measurement (Using Imito App)
Global Improvement Score assessed by Physician
Side Effects Evaluation
Statistical significance of improvement (Placental Extract vs PRP). |
Week 0 , Week 4 , Week 8 , Week 12 |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
17/12/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
17/12/2025 |
| 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
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [mansichavan105@gmail.com].
- For how long will this data be available start date provided 01-01-2028 and end date provided 01-01-2033?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This is a split-face, non-randomised controlled , single center trial comparing the efficacy and safety of microneedling with Human Placental Extract versus microneedling with Platelet Rich Plasma (PRP) in 30 patients with striae distensae . The primary outcome will be change in scar score, measured at baseline, after each treatment session, and at the end of treatment (12 weeks). Secondary outcomes will include patient satisfaction (VAS) and global assessment score , both measured at baseline and final follow-up, along with the adverse effect profile recorded at every session and follow-up visit. This study will provide evidence regarding the relative effectiveness of these two modalities in improving the appearance of striae distensae. |