| CTRI Number |
CTRI/2018/07/014864 [Registered on: 13/07/2018] Trial Registered Retrospectively |
| Last Modified On: |
11/07/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Laser (Q-switched Nd:YAG laser)] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison between high dose and low dose laser therapy (Nd:YAG laser) for facial pigmentation (melasma) |
|
Scientific Title of Study
|
Comparison of Melasma Area and Severity Index (MASI) scores between low fluence and high fluence Q-switched Nd:YAG laser for refractory melasma: A randomized controlled 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 Jude Ernest Dileep |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER) |
| Address |
Department of Dermatology, Venereology and Leprology,
JIPMER,
Dhanvantri Nagar,
Gorimedu,
Pondicherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9159930448 |
| Fax |
|
| Email |
judegenext@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rashmi Kumari |
| Designation |
Associate Professor |
| Affiliation |
JIPMER |
| Address |
Department of Dermatology and STD JIPMER.
Pondicherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9489692199 |
| Fax |
|
| Email |
rashmi.sreerag@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rashmi Kumari |
| Designation |
Associate Professor |
| Affiliation |
JIPMER |
| Address |
Department of Dermatology and STD JIPMER.
Pondicherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9489692199 |
| Fax |
|
| Email |
rashmi.sreerag@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Dermatology and STD, Main OPD Block, JIPMER Pondicherry- 605006 |
|
|
Primary Sponsor
|
| Name |
Department of Dermatology JIPMER |
| Address |
Department of Dermatology and STD , Main OPD Block JIPMER,
Puducherry – 605006 |
| 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 Jude Ernest Dileep |
JIPMER |
OPD Number 85
Department of
Dermatology Main OPD
Block JIPMER,
Pondicherry
Pondicherry
PONDICHERRY |
9159930448
judegenext@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee (Human Studies) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
All patients of refractory melasma who have not shown complete clearance after 6 weeks of topical triple combination therapy and topical sunscreens attending the dermatology OPD, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
High fluence Q-switched Nd:YAG laser therapy |
Laser therapy will be provided at a fluence of 5-6 Joules per sq cm for 3 sessions at 4 weekly intervals |
| Comparator Agent |
Low fluence Q-switched Nd:YAG laser therapy |
Laser therapy will be provided at a fluence of 2-2.5 Joules per sq cm for a maximum of 12 sessions at weekly intervals. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All patients of refractory melasma who have not shown complete clearance after 6 weeks of topical triple combination therapy and topical sunscreens attending the dermatology OPD. |
|
| ExclusionCriteria |
| Details |
1. Other causes of facial melanosis (such as lichen planus pigmentosus, erythema dyschronicum perstans, pigmented contact dermatitis, post-inflammatory hyperpigmentation)
2. Pregnant and lactating mothers
3. Patients currently using oral contraceptives
4. History of endocrinopathies |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Post-treatment Melasma Area and Severity Index (MASI) scores |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Side effects |
3 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "36"
Final Enrollment numbers achieved (India)="36" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/10/2017 |
| Date of Study Completion (India) |
30/06/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
In this trial, we aim to compare between laser treatment regimens involving low fluence and high fluence Q-switched Nd:YAG laser for melasma refractory to topical medications. This study aims to identify the ideal treatment regimen in dark skinned individuals of our population so as to maximize clinical efficacy and minimise side effects |