| CTRI Number |
CTRI/2025/05/086774 [Registered on: 13/05/2025] Trial Registered Prospectively |
| Last Modified On: |
10/05/2025 |
| 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
|
Fractional CO2
Laser versus Q-Switched Nd:YAG Laser in Melasma |
|
Scientific Title of Study
|
Comparing the Efficacy of Combination of Q-Switched Nd:YAG and Fractional CO2
Lasers versus Q-Switched Nd:YAG Laser alone in Melasma: A Split-face Randomised
Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Piyush Meena |
| Designation |
Junior Resident |
| Affiliation |
AIIMS Jodhpur |
| Address |
Room 107, Dermatology OPD, 1A-OPD Block
AIIMS Hospital, Basni Phase-2
Jodhpur
RAJASTHAN
342005
India |
| Phone |
6377330990 |
| Fax |
|
| Email |
piyushmeena1132001@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anil Budania |
| Designation |
Additional Professor |
| Affiliation |
AIIMS Jodhpur |
| Address |
Room 107, Dermatology OPD, 1A-OPD Block
AIIMS Hospital, Basni Phase-2
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9213361424 |
| Fax |
|
| Email |
anilbuddy25@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Piyush Meena |
| Designation |
Junior Resident |
| Affiliation |
AIIMS Jodhpur |
| Address |
Room 107, Dermatology OPD, 1A-OPD Block
AIIMS Hospital, Basni Phase-2
Jodhpur
RAJASTHAN
342005
India |
| Phone |
6377330990 |
| Fax |
|
| Email |
piyushmeena1132001@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS Jodhpur,
Basni Phase-2
Jodhpur, 342005
Rajasthan, India |
|
|
Primary Sponsor
|
| Name |
AIIMS Jodhpur |
| Address |
Basni Industrial Area Phase-2 Jodhpur-342005 |
| 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 Piyush |
AIIMS Jodhpur Hospital |
Room 107, Dermatology OPD, 1-A OPD Block, AIIMS Jodhpur Hospital Basni Phase 2, PINCODE: 342005
Jodhpur
RAJASTHAN |
6377330990
piyushmeena1132001@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| All India Institute of Medical Sciences Banni Jodhpur Rajasthan |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L811||Chloasma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Fractional Co2 laser, Q-switched Nd:YAG laser |
The combination treatment has been found to be better than either one in few studies with better efficacy and fewer side effects.
We wish to study and compare this combination versus widely used Q-switched Nd:YAG laser alone.
Our study is a split face study, we will perform two lasers over one half of the face (randomly assigned) while only Q-switched Nd:YAG laser will be done over another half of face.
We aim to compare the clinical efficacy and safety between both the groups.
Fractional Co2 laser will be done every four weekly i.e monthly for a total of three times, while Q-switched Nd:YAG laser will be done every two weekly for a total of six times. |
| Comparator Agent |
Q-switched Nd:YAG laser |
It is known effective and safe laser option in Melasma.
Q-switched Nd:YAG laser will be done every two weekly for a total of six times. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Clinically diagnosed Melasma
|
|
| ExclusionCriteria |
| Details |
Any one of the following-
1. Pregnant and/ or lactating women
2. Women taking oral contraceptives or hormonal replacement therapy
3. Patients taking oral or topical treatment for Melasma 4 weeks prior to the study
4. Any known systemic illness
5. Active skin disease present locally
6. History of Photosensitive disorder
7. Patients having keloidal tendency
8. Bleeding diathesis
9. Unwilling to participate |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparing efficacy of both groups by the change in modified MASI score and Physician Global Assessment (PGA) score. |
At each follow up visit. Final assessment will be done 2 weeks after the last session. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess dermoscopic changes in both treatment groups.
2. To observe and assess side effects in both treatment groups
3. To evaluate patient satisfaction using a percentage-based scoring system |
At each follow up visit. Final assessment will be done 2 weeks after the last session. |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
22/05/2025 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response (Others) - Data will be available to researchers who provide a methodologically sound proposal for use in research that has been approved by an independent ethics committee.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [piyushmeena1132001@gmail.com].
- For how long will this data be available start date provided 07-05-2027 and end date provided 07-01-2100?
Response (Others) - Beginning 9 months following article publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Patients with clinically diagnosed melasma visiting the Dermatology OPD at AIIMS Jodhpur during the study period will be recruited based on inclusion and exclusion criteria after a written informed consent. Through our study we want to find whether the combination of Q-switched Nd:YAG and Fractional CO2 lasers provide better clinical improvement than Q-switched Nd:YAG laser alone in Melasma. This split-face randomized controlled trial will last approximately 18 months. Using block randomization method we will randomly assign one half of the face to receive both lasers, while the other half will receive only the Q-switched Nd:YAG laser. After the patient is recruited, he/she will be started on topical sunscreen with spf>30. The first laser session will be held after 4 weeks, followed by sessions every 2-4 weekly. Q-switched Nd:YAG laser will be done every 2 weekly while Fractional Co2 laser will be done monthly. A total of 6 sittings of Q-switched Nd:YAG and 3 sittings of Fractional Co2 will be done in combination group while only 6 sittings of Q-switched Nd:YAG laser will be done in another group. We will compare efficacy using Photography, Modified MASI scoring, Physician Global Assessment (PGA) scoring, and dermoscopic evaluation, and monitor side effects. All information will be recorded on a pre-designed proforma, and photographic records will be maintained. Patient satisfaction will be measured using a percentage-graded score. Final assessment will be done 2 weeks after the last laser session. Our study can help us understand the effect of combination of Q-Switched Nd:YAG and Fractional CO2 lasers in Melasma better. Also it will guide us in formulating standardized laser protocol for Indian Melasma patients. |