| CTRI Number |
CTRI/2022/12/048400 [Registered on: 22/12/2022] Trial Registered Prospectively |
| Last Modified On: |
06/12/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Comparing effect of injecting platelet rich plasma with microneedling versus micro needling alone on face for treatment of post acne scars |
|
Scientific Title of Study
|
A split face study to compare the efficacy of platelet rich plasma combined with micro needling versus micro needling alone for treatment of acne scars |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jeyashree |
| Designation |
DNB PG 1st year |
| Affiliation |
Indira Gandhi medical college and research institute |
| Address |
Department of dermatology venereology and leprosy, Indira Gandhi medical college and research institute
Pondicherry
PONDICHERRY
605009
India |
| Phone |
08056699678 |
| Fax |
|
| Email |
jeyashreedamodaran@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrSarithaM |
| Designation |
Associate professor |
| Affiliation |
Indira Gandhi medical college and research institute |
| Address |
Department of dermatology venereology and leprosy,
IGMCRI,
Kathirkamam
Pondicherry
PONDICHERRY
605009
India |
| Phone |
9443397873 |
| Fax |
|
| Email |
saritha_mohanan@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Jeyashree |
| Designation |
DNB PG 1st year |
| Affiliation |
Indira Gandhi medical college and research institute |
| Address |
Department of dermatology venereology and leprosy,
IGMCRI,
Kathirkamam
Pondicherry
PONDICHERRY
605009
India |
| Phone |
08056699678 |
| Fax |
|
| Email |
jeyashreedamodaran@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indira gandhi medical college and research institute |
|
|
Primary Sponsor
|
| Name |
Jeyashree |
| Address |
19,20 mangammal salai,thirunagar,Madurai |
| 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 |
| Jeyashree |
Indira gandhi medical college and research institute |
OP no.2 ,Department of dermatology venereology and leprosy
Indira gandhi medical College and research institute,
Vazhudavoor road,Kathirkamam,Pondicherry
605009
Pondicherry
PONDICHERRY |
8056699678
jeyashreedamodaran@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Indira Gandhi medical college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Micro needling alone |
Micro needling with Dermaroller on other side of face 4 weeks once , total of three sittings |
| Intervention |
Micro needling with PRP |
Micro needling using Dermaroller with PRP application on one side of the face 4 weeks once , total of 3 sittings |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
grade 2 to grade 4 atrophic acne scars (based on Goodman and Baron’s qualitative classification) ,with quantitatively equal scores on both halves of the face ,without any active acne and who are willing to participate in the study |
|
| ExclusionCriteria |
| Details |
1.Positive history of keloidal tendency.
2.Positive history of bleeding or platelet disorder.
3. Positive history of major surgery in past 6 months.
4.Presence of any acute infection on face like, herpes, folliculitis. 5.Patients of HIV, HBsAg, or any chronic illness.
6.Pregnancy.
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
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Primary Outcome
|
| Outcome |
TimePoints |
| To compare the mean reduction in acne scar using Goodman Baron quantitative scale of assessment for acne scars |
4 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
compare photographs pre and post treatment of both sides of the face using the assessment by an independent physician (dermatologist)
|
4 months |
| compare patient satisfaction scores for either side of the face before treatment and 1month after the end of the last session |
4 months |
|
|
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)
|
01/01/2023 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
- Acne scar is a major cosmetic concern for a patient and presents a challenge to a dermatologists due to lack of effective treatment modalities.[10]
- Although many treatment modalities are currently being used, they have shown improvement to a limited extent with possible side effects. (11)
- Multiple minimally invasive sessions of micro needling is an effective treatment for post acne atrophic scars as it stimulates the repair processes with the advantage of being relatively risk free, in office procedure with minimal patient recovery time (12)
- PRP provides various growth factors which aid in quick wound healing
- This study proposes that PRP can be used as an effective adjuvant therapy to be used along with standard micro needling therapy
- All previously done studies showed no significant change in Goodman and barons score at the end point. This study is to perform the procedure in a Fitzpatrick 4 to 6 skin type with southern type of climatic conditions and to compare the efficacy and adverse effects.
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