| CTRI Number |
CTRI/2018/04/013498 [Registered on: 26/04/2018] Trial Registered Retrospectively |
| Last Modified On: |
22/04/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A split face study comparing the efficacy of laser and micro needling in the treatment of acne scars |
|
Scientific Title of Study
|
A split face randomized controlled study comparing the efficacy of fractional CO2 laser and microneedling in the 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 |
Dr G Seturaman |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of Dermatology and Venereology, All India Institute of Medical Science, New Delhi, India
New Delhi
DELHI
110029
India
New Delhi
DELHI
110029
India |
| Phone |
01125694369 |
| Fax |
|
| Email |
aiimsgsr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr G Seturaman |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of Dermatology and Venereology, All India Institute of Medical Science, New Delhi, India
New Delhi
DELHI
110029
India
New Delhi
DELHI
110029
India |
| Phone |
01125694369 |
| Fax |
|
| Email |
aiimsgsr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priyesh |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of Dermatology and Venereology, All India Institute of Medical Science, New Delhi, India
New Delhi
DELHI
110029
India
New Delhi
DELHI
110029
India |
| Phone |
9818760018 |
| Fax |
|
| Email |
priyeshthakran@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Ansari Nagar, New Delhi-110029 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences |
| Address |
Ansari Nagar New Delhi 110029 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 G Sethuraman |
All india institute of medical sciences |
Room no.-1141, First floor, department of dermatology and venereology, Rajkumari Amrit Kaur OPD, AIIMS, New Delhi
South
DELHI |
9654430854
aiimsgsr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee- All India Institute of Medical Sciences, New Delhi, India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Post acne scar, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Fractional CO2 Laser
|
3 sessions, 6 weeks apart
wavelength 10600nm
on one half of cheek by investigator |
| Intervention |
Microneedling |
6 sessions, 3 weeks apart
1.5mm long needles to be rolled on the other side of the cheek by the investigator |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
ï®All patients of mild to severe atrophic facial acne scars
ï®Age: ≧14 years |
|
| ExclusionCriteria |
| Details |
Age group < 16 years
Patients who received Isotretinoin or underwent resurfacing laser procedures within the preceding 6 months
Active acne lesions
Active Herpes virus infection
Pregnancy and lactation
Tendency of Keloid formation
Patients allergic to Lidocaine |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pre and Post Photographic evaluation score by 2 unbiased dermatologist
|
Baseline, 6 weeks, 12 weeks and 3 months after completion of therapy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Subjective assessment score.
2.Improvement Grading
3.Dermatology Life Quality Index (DLQI)
|
Baseline, 6 weeks, 12 weeks and 3 months after completion of therapy |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
18/01/2017 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Acne has a prevalence of over 90% among adolescents and persists into adulthood in approximately 12%-14% of cases with significant psychological and social implications. Post acne scarring is a recognized sequel of acne, but its actual extent and incidence is unknown. Results indicate that facial scarring affects both sexes equally and occurs in almost 95% cases. This study aims to compare the efficacy of fractional CO2 Laser vs Microneedling in treatment of post acne scar patients in a split face randomized study design.
|