| CTRI Number |
CTRI/2016/09/007235 [Registered on: 05/09/2016] Trial Registered Retrospectively |
| Last Modified On: |
31/08/2016 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [acne scar resurfacing] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to compare two procedures for acne scars on face - microdermabrasion and Er:YAG laser |
|
Scientific Title of Study
|
Efficacy and safety of Er:YAG laser in comparison with microdermabrasion in facial acne scarring: A randomized clinical trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rashmi kumari |
| Designation |
Associate professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Department of Dermatology and STD,
JIPMER,
Pondicherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
09489692199 |
| Fax |
|
| Email |
rashmi.sreerag@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rashmi kumari |
| Designation |
Associate professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Department of Dermatology and STD,
JIPMER,
Pondicherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
09489692199 |
| Fax |
|
| Email |
rashmi.sreerag@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rashmi kumari |
| Designation |
Associate professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Department of Dermatology and STD,
JIPMER,
Pondicherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
09489692199 |
| Fax |
|
| Email |
rashmi.sreerag@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Institute of Postgraduate Medical Education and Research |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Dhanvantri nagar, Gorimedu, Pondicherry- 605006 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Rashmi kumari |
JIPMER hospital |
JIPMER hospital, Dhanvantri nagar, Gorimedu, Pondicherry- 605006
Pondicherry
PONDICHERRY |
09489692199
rashmi.sreerag@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee (Human studies), JIPMER, Pondicherry |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
facial acne scars, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Er:YAG laser |
Er:YAG laser 4-6 sittings |
| Intervention |
Microdermabrasion |
Microdermabrasion 4-6 sittings
|
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Adult males or females with atrophic acne scars of grades 2,3 and 4 |
|
| ExclusionCriteria |
| Details |
• Age less than 12 years and greater than 60 years.
• Pregnant and lactating women.
• Active acne.
• Coexisting inflammation in adjacent skin secondary to dermatological diseases such as psoriasis, lichen planus, eczemas, acne.
• Keloidal tendency.
• On isotretinoin for last 6 months to 1 year.
• Patients with unrealistic expectations or psychiatric illnesses.
• Preexisting bleeding disorder, renal or hepatic diseases.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| clinical improvement in facial acne scars between two groups (Microdermabrasion, Er:YAG) |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| side effects, change in quality of life between two groups |
1 year |
|
|
Target Sample Size
|
Total Sample Size="102"
Sample Size from India="102"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
03/02/2014 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a randomized controlled, parallel designed, single blinded study comparing the safety and efficacy of two acne scar resurfacing procedures namely microdermabrasion and Er:yag laser. After randomization 52 patients underwent mirodermabrasion and 50 patients underwent Er:YAG laser resurfacing. In each group patients underwent 4-6 sessions of treatment. Patients were followed up at 1 and 6 months after last treatment session. The primary outcome (clinical improvement) was assessed by a blinded dermatologist through photographic comparison before and after treatment. Simultaneously improvement was assessed by investigator (ECCA score) and patients (questionnaire) also. The secondary outcomes assessed were side effects and change in quality of life in partients in each group. |