| CTRI Number |
CTRI/2025/04/085033 [Registered on: 17/04/2025] Trial Registered Prospectively |
| Last Modified On: |
16/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Use of Er-YAG laser for treating acne scars |
|
Scientific Title of Study
|
Efficacy and safety of fractional Erbium-YAG laser in patients with atrophic acne scars: a prospective interventional study
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Tulika Rai |
| Designation |
Professor |
| Affiliation |
Institute of Medical Sciences, Banaras Hindu University |
| Address |
Department of Dermatology Institute of Medical Sciences Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9161023651 |
| Fax |
|
| Email |
raitulika1323@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Atul Mohan |
| Designation |
Senior resident |
| Affiliation |
Institute of Medical Sciences, Banaras Hindu University |
| Address |
Department of Dermatology Institute of Medical Sciences Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8650315384 |
| Fax |
|
| Email |
dratulmohan1994@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Atul Mohan |
| Designation |
Senior resident |
| Affiliation |
Institute of Medical Sciences, Banaras Hindu University |
| Address |
Department of Dermatology Institute of Medical Sciences Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8650315384 |
| Fax |
|
| Email |
dratulmohan1994@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Department of Dermatology Institute of Medical Sciences Banaras Hindu University |
| Address |
Department of Dermatology Institute of Medical Sciences Banaras Hindu University Varanasi 221005 |
| 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 |
| Dr Tulika Rai |
Sir Sunderlal Hospital |
Department of dermatology OPD number 207, Banaras Hindu University, Varanasi
Varanasi
UTTAR PRADESH |
09161023651
raitulika1323@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L708||Other acne, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Erbium YAG laser 2940nm |
Test patch was done at 1400mJ long mode and patients were monitored for any adverse events. If test patch was eventful 4 sessions of 2 passes of Er-YAG laser were done at every 4 weeks. First pass was done at fluence 1800mJ long mode and second pass at fluence 600mJ medium mode. |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
All patients presenting with Goodman and Baron Grade II III and IV acne scars.
Males and females in the age group of 18 to 40 years.
Motivated patients willing to come for follow-up.
|
|
| ExclusionCriteria |
| Details |
Presence of active acne lesions.
Patients having keloids or a keloidal tendency.
History of any bleeding disorder and slash or patients taking anticoagulants.
Patients taking oral steroids.
Active skin infections like warts, herpes, or any bacterial infection.
Pregnancy and lactation.
Patients taking high dose isotretinoin.
Patients having undergone any surgery or procedure for acne scars in the preceding three months. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of improvement in acne scars using Goodman and Baron quantitative grading system. |
Assessment of improvement in acne scars using Goodman and Baron quantitative grading system at every 4 weeks for 4 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| None |
None |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
10/05/2025 |
| 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="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
All patients with post acne atrophic scars, aged 18-40 years, underwent 4 sessions of Er-YAG laser 2940nm at every 4 weeks. Efficacy was measured according to the quantitative as well as qualitative Goodman and Baron grading system for acne scars. Adverse events were monitored at every visit. Final response was recorded after 4 weeks of last session of Er-YAG laser. |