| CTRI Number |
CTRI/2023/06/054031 [Registered on: 16/06/2023] Trial Registered Prospectively |
| Last Modified On: |
22/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of the Efficacy of 3 modalities for the treatment of Striae Distensae or Stretchmarks - Fractional Carbon Dioxide Laser versus Autologous Platelet Rich Plasma versus Microneedling with topical Aloe Vera Gel. |
|
Scientific Title of Study
|
Efficacy of Fractional Carbon Dioxide Laser versus Autologous Platelet Rich Plasma versus Microneedling with topical Aloe Vera Gel in the Treatment of Striae Distensae |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Sumedha Tirthani |
| Designation |
Junior resident |
| Affiliation |
R L Jalappa Hospital |
| Address |
Room no. 26, Department of Dermatology, RL Jalappa Hospital, Sri Devaraj Urs Medical College, Tamaka, Kolar
Kolar
KARNATAKA
563101
India |
| Phone |
8989430500 |
| Fax |
|
| Email |
sumedhatirthani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Rajashekar TS |
| Designation |
Professor and Head of Department, Department of Dermatology, Sri Devaraj Urs Medical College |
| Affiliation |
R L Jalappa Hospital |
| Address |
Room no 26, Department of Dermatology, Sri Devaraj Urs Medical College Kolar
Kolar
KARNATAKA
563101
India |
| Phone |
9448316136 |
| Fax |
|
| Email |
yeshitss1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Sumedha Tirthani |
| Designation |
Junior resident |
| Affiliation |
R L Jalappa Hospital |
| Address |
Room no 26, Department of Dermatology, RL Jalappa Hospital, Sri Devaraj Urs Medical College Kolar
Kolar
KARNATAKA
563101
India |
| Phone |
8989430500 |
| Fax |
|
| Email |
sumedhatirthani@gmail.com |
|
|
Source of Monetary or Material Support
|
| RL Jalappa Hospital, Sri Devaraj Urs Medical College, Tamaka, Kolar |
|
|
Primary Sponsor
|
| Name |
Dr Sumedha Tirthani |
| Address |
Department of Dermatology, Sri Devaraj Urs Medical College, Kolar, Karnataka 563101 |
| 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 |
| Dr Sumedha Tirthani |
RL Jalappa Hospital, Sri Devaraj Urs Medical College |
Room no 26, Department of Dermatology, RL Jalappa Hospital, Sri Devaraj Urs Medical College
Kolar
KARNATAKA |
8989430500
sumedhatirthani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Devaraj Urs Medical College Institutional ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R234||Changes in skin texture, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Fractional Carbon Dioxide Laser |
For 6 sittings at 3 week intervals |
| Intervention |
MICRONEEDLING WITH TOPICAL ALOE VERA GEL |
For 6 sittings at 3 week intervals |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Platelet Rich Plasma |
For 6 sittings at 3 week intervals |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of both genders with striae Distensae of all grades over any site on the body
2. Patients who have not taken treatment for striae distensae either topppical or systemic in the past 6 months |
|
| ExclusionCriteria |
| Details |
1.Patients on systemic isotretinoin or corticosteroids.
2.Patients with history of keloid formation.
3.Patients with any connective tissue disease.
4.Patients with disease affecting the wound-healing process.
5.Patients with other systemic illness – cardiac, renal, hepatic illness.
6.Severely Immunocompromised
7.Pregnancy, Lactation
8.Patients who have cold intolerance
9.Patients taking photosensitive drugs and photosensitivity
10.Patient not willing for study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Measurement of efficacy of modalities on the basis of quartile grading score.
2. % reduction in width of Striae
3. Patient satisfaction using Likert Satisfaction scale |
1. before each setting - every 3 weeks
2, 3 - at end of 6 settings and 3 weeks after the last setting - at 15 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Post procedural adverse effects & healing effects of Fractional Carbon Dioxide Laser, PRP, and Microneedling with topical aloe vera gel in treatment of striae distensae. |
1. before each setting - every 3 weeks, at end of 6 settings |
|
|
Target Sample Size
|
Total Sample Size="108"
Sample Size from India="108"
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)
|
25/06/2023 |
| 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="5"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is to Determine the efficacy of Fractional CO2 Laser versus PRP versus Microneedling with Aloe Vera Gel in the treatment of Striae Distensae. As of now, no study has been done to compare these three groups. Thus making this study a first of its kind. |