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CTRI Number  CTRI/2024/07/071283 [Registered on: 25/07/2024] Trial Registered Prospectively
Last Modified On: 18/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Micro needling Radiofrequency with platelet rich plasma injection ]  
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A Prospective study to evaluate Effectiveness and safety of Microneedling Fractional Radiofrequency (MnRF) and Microneedling Fractional Radiofrequency (MnRF) with platelet rich plasma therapy(PRP) in the Treatment of Striae Distensae  
Scientific Title of Study   Effectiveness and safety of Microneeding Fractional Radiofrequency (MnRF) and Microneedling Fractional Radiofrequency (MnRF) with platelet rich plasma therapy (PRP) in the Treatment of Striae Distensae-A randomized controlled trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Varshini N R 
Designation  Post graduate student  
Affiliation  SRM Medical College Hospital and Research Centre 
Address  C 15, Department of dermatology, SRM Medical College Hospital, Potheri, SRM Nagar, Kattankulathur

Chennai
TAMIL NADU
603203
India 
Phone  8105509238  
Fax    
Email  nrvarshu@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Murali N 
Designation  HOD Department of dermatology 
Affiliation  SRM Medical College Hospital and Research Centre 
Address  C 15, Department of dermatology, SRM Medical College Hospital, Potheri, SRM Nagar, Kattankulathur

Chennai
TAMIL NADU
603203
India 
Phone  9840168711  
Fax    
Email  leecutis@gmail.com  
 
Details of Contact Person
Public Query  
Name  Varshini N R 
Designation  Post graduate student  
Affiliation  SRM Medical College Hospital and Research Centre 
Address  C 15, Department of dermatology, SRM Medical College Hospital, Potheri, SRM Nagar, Kattankulathur

Chennai
TAMIL NADU
603203
India 
Phone  8105509238  
Fax    
Email  nrvarshu@gmail.com  
 
Source of Monetary or Material Support  
SRM Medical College Hospital and research, SRM Nagar, Potheri, Kattankulathur, Tamilnadu, India - 603203 
 
Primary Sponsor  
Name  SRM Medical College Hospital and research centre  
Address  Room no 15, C block, Department of Dermatology, SRM Medical College Hospital, Kattankulathur, Tamil Nadu - 603203 
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 Varshini N R  SRM Medical College Hospital and research centre   C15, Department of dermatology, SRM Medical College Hospital and research centre , Potheri, SRM Nagar, Kattankulathur
Kancheepuram
TAMIL NADU 		 8105509238

nrvarshu@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SRM Medical College Hospital, Institutional Ethical committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L906||Striae atrophicae,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Microneedling Fractional Radiofrequency (MnRF)  Group A – MnRF is given, one sitting,once in 4 weeks that is for 4 sittings - Week 0,4,8,12.Follow up pictures will be taken at week 16 and 24. Prior to each treatment session, clinical photographs were taken. EMLA cream (Lignocaine 2.5% and Prilocaine 2.5%) was applied to the targeted regions of striae distensae for 40 min followed by gentle cleansing. The procedure area were painted with povidone iodine and cleaned with 70% isopropyl alcohol as a disinfectant, using sterile precautions. Subjects with striae distensae were subjected to receiving four sequential micro-needling radio-frequency sessions with an interval of 4 weeks between each session. The energy delivery system consists of a disposable tip with 25-89 gold-plated insulated microneedle electrodes (depending of the dimensions of the striae) with a maximum energy output of 50 W. The depth of the needle can be adjusted from a minimum of 0.5 mm to a maximum of 3.0 mm. In each session, two passes were administered. Disposable micro radio-frequency needles were used for every patient in each session. Post procedure, the sites were wiped gently with cold water and an ice pack was applied for 5 min to alleviate discomfort and minimize swelling. Subjects were advised to apply emollients. Any post procedure erythema persisting for more than 3 days were treated with topical steroid cream, mometasone furoate cream for 3 days.  
Comparator Agent  Microneedling Fractional Radiofrequency (MnRF) with platelet rich plasma therapy(PRP)  Group B – MnRF with PRP given for striae once in 4 weeks for 4 sittings - week 0,4,8,12 and follow up pictures will be taken at week 16 and 24 Process of extracting PRP: Double spin – Open method About 0.05-0.1 mL (2 to 4 units) of PRP is injected per cm area intradermally using insulin syringe sequentially to cover the affected site completely.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  All Patients above 18 years of age attending SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE Dermatology OPD, diagnosed with striae distensae.
2. Patients willing to refrain from all other oral and topical medications for striae distensae.
3. Patients providing voluntary informed and written consent for the explained treatment modality to be performed 
 
ExclusionCriteria 
Details  1. Patients who have received treatment for SD in the past 3 months.
2. Pregnant and lactating women.
3. Patients with active infections at the site.
4. Patients with history of photosensitive disorders like lupus erythematosus, dermatomyositis.
5. Patients with history of propensity for keloid formation and vitiligo. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Clinical assessment of improvement of striae according to Global Aesthetic Improvement Scale (GAIS), SDA scoring scale by a side by side comparison of Pre-operative and post-operative photographs taken at every visit and at the end of 4 weeks and 12weeks after the last session.
 		 Week 0, 4, 8, 12, 16, 24 
 
Secondary Outcome  
Outcome  TimePoints 
Patient satisfaction score at the end of the study   24th week 
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
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)   30/07/2024 
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="0"
Months="6"
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

  3. Who will be able to view these files?
    Response - Anyone

  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 [nrvarshu@gmail.com].

  6. For how long will this data be available start date provided 26-06-2024 and end date provided 15-01-2025?
    Response - Beginning 3 months and ending 5 years following article publication.

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

Patients will be randomized into 2 groups – group A and group B

➢  Group A – 32 patients - MnRF given for striae once in 4 weeks for 4 sittings.

  Group B – 32 patients – MnRF with PRP given for striae once in 4 weeks for 4 sittings


Type of randomization & method used- The sample shall be randomized according to a computer generated algorithm. 

Blinding - Assessor blinding

Brief procedure 


GROUP A – PROCEDURE

•       Prior to each treatment session, clinical photographs will be taken. PRILOX cream (Lignocaine 2.5% and Prilocaine 2.5%) will be applied to the targeted regions of striae distensae for 40 min followed by gentle cleansing.

•        The procedure area will be painted with povidine iodine and cleaned with 70% isopropyl alcohol as a disinfectant, using sterile precautions.

•       Patients with striae distensae will be subjected to receiving four sequential microneedling radiofrequency sessions with an interval of 4 weeks between each session. The energy delivery system consists of a disposable tip with 25-89 gold-plated insulated microneedle electrodes(depending of the dimensions of the striae) with a maximum energy output of 50 W. The depth of the needle can be adjusted from a minimum of 0.5 mm to a maximum of 3.5 mm.

•           In each session, two passes will be administered.

•       Disposable micro radiofrequency needles will be used for every patient in each session.

•       Post procedure, the sites will be wiped gently with cold water and an ice pack was applied for 5 min to alleviate discomfort and minimize swelling.

•       Patients will be advised to apply emollients.

•       Any post procedure erythema persisting for more than 3 days will be treated with topical steroid cream.

 

GROUP B – PROCEDURE

•       In addition to the above mentioned procedure, PRP will be injected intralesionally.

•       Process of extracting PRP: Double spin – Open method

 

ASSESSMENT

Clinical assessment by a blinded assessor of the improvement of striae according to Global Aesthetic Improvement Scale (GAIS), SDA scoring scale, adverse effects by a side by side comparison of Pre-operative and post-operative photographs taken at every visit and at the end of 4 weeks and 12weeks after the last session.


 
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