| CTRI Number |
CTRI/2022/11/047100 [Registered on: 07/11/2022] Trial Registered Prospectively |
| Last Modified On: |
04/11/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
COMPARISON OF TWO METHODS IN TREATMENT OF SCARS. |
|
Scientific Title of Study
|
FRACTIONAL CO2 LASER VERSUS MICRONEEDLING WITH PLATELET RICH PLASMA IN PATIENTS WITH ACNE SCARS - A RANDOMIZED CONTROL TRIAL |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr SUPRIYA GUPTA |
| Designation |
associate professor |
| Affiliation |
rohilkhand medical college and hospital |
| Address |
room no.1196, DERMATOLOGY DEPARTMENT,ROHILKHAND MEDICAL COLLEGE AND HOSPITAL, PILIBHIT BYPASS ROAD, BAREILLY
rohilkhand medical college and hospital, pilibhit bypass road, pawan vihar,bareilly
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
9837088838 |
| Fax |
|
| Email |
agsup23@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
chanchal chauhan |
| Designation |
junior resident |
| Affiliation |
rohilkhand medical college and hospital, bareilly |
| Address |
room no 44, girls pg hostel no.2 , rohilkhand medical college and hospital, bareilly
rohilkhand medical college and hospital, pilibhit bypass road, pawan vihar,bareilly
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
9958041287 |
| Fax |
|
| Email |
chanchalneemrana@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr SUPRIYA GUPTA |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
ROHILKHAND MEDICAL COLLEGE AND HOSPITAL ,BAREILLY |
| Address |
room no.1196, DERMATOLOGY DEPARTMENT,ROHILKHAND MEDICAL COLLEGE AND HOSPITAL, PILIBHIT BYPASS ROAD, BAREILLY
rohilkhand medical college and hospital, pilibhit bypass road, pawan vihar,bareilly
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
9837088838 |
| Fax |
|
| Email |
agsup23@gmail.com |
|
|
Source of Monetary or Material Support
|
| rohilkhand medical college and hospital,pilbhit bypass road, pawan vihar, bareilly, pin code: 243006, uttar pradesh
0581 2526011 |
|
|
Primary Sponsor
|
| Name |
supriya agarwal |
| Address |
ROOM NO.1196,DERMATOLOGY DEPARTMENT, ROHILKHAND MEDICAL COLLEGE AND HOSPITAL, BAREILLY |
| 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 SUPRIYA GUPTA |
ROHILKHAND MEDICAL COLLEGE AND HOSPITAL,BAREILLY |
Room no. 1196, ROHILKHAND MEDICAL COLLEGE AND HOSPITAL, PILIBHIT BYPASS ROAD, BAREILLY
Bareilly
UTTAR PRADESH |
9837088838
agsup23@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, RMCH,BAREILLY,U.P. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L989||Disorder of the skin and subcutaneous tissue, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
fractional CO2 laser in patients with acne scars. |
A total of four sittings at regular four weekly inervalswill be performed in four months. |
| Intervention |
microneedling with platelet rich plasma in patients with acne scars. |
A total of five sittings at regular three weekly interval will be performed in four months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
PATIENTS AGED BETWEEN 18-35 YEARS OF AGE GROUP PRESENTING WITH FACIAL ATROPHIC ACNE SCARS AND HAVING REALISTIC EXPECTATIONS |
|
| ExclusionCriteria |
| Details |
1.ISOTRETINOIN USE FOR PAST THREE MONTHS.
2.ACTIVE LESIONS OF ACNE AND HERPES SIMPLEX.
3.PATIENTS WITH HISTORY OF BLEEDING DIATHESIS.
4.PATIENTS ON ORAL ANTI COAGULANTS OR ACNE INDUCING DRUGS.
5.PREGNANT WOMEN.
6.PATIENTS WITH HYPERTROPHIC SCARRING OR KELOIDAL TENDENCY.
7.SYSTEMIC ILLNESSES E.G. COLLAGEN AND VASCULAR DISEASES,UNCONTROLLED DIABETES MELLITUS, AND NEUROMUSCULAR DISORDERS.
8.PARTIENTS WITH HISTORY OF INJECTIONS OF COLLAGEN, OR OTHER INJECTABLE FILLERS WITHIN PAST 6 MONTHS
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to compare the efficacy of fractional CO2 laser and microneedling, by using dermaroller with PRP in patients with facial atrophic acne scars by using Arora Swati et al. grading system before and after the treatment. |
at the end of the treatment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To assess the demographic characteristics of patients having facial atrophic acne scars.
2. To assess the clinical improvement in grading of facial acne scars in both the groups.
3.To determine the safety profile and compliance of fractional CO2 laser/ microneedling with PRP in facial atrophic acne scars. |
At the end of the treatment. |
|
|
Target Sample Size
|
Total Sample Size="88"
Sample Size from India="88"
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)
|
15/11/2022 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
These days a lot of treatment modalities are available for the treatment of acne scars like medical therapy, chemical agents, surgical therapy, mechanical devices, laser and energy-based devices, tissue augmentation and regenerative procedures. One of the most accepted treatment for acne scars is Fractional CO2 laser. It helps in skin rejuvenation, decreases the depth of defect and has clinically favorable outcome. By performing microneedling with the help of a dermaroller we are basically stimulating the migration and proliferation of fibroblasts which further results in collagen deposition hence decreasing the depth of defect and thus correcting the atrophic acne scar. Platelet rich plasma, is platelets concentrate present in a small volume of plasma. Present with a lot of growth factors and cytokines thus playing an important role in tissue repair and promoting tissue regeneration. Previously studies have been done comparing various modalities on acne scars, but there is paucity of data between comparison of fractional CO2 laser and microneedling by using dermaroller along with PRP for facial atrophic acne scars, hence this study is being planned to be done |