| CTRI Number |
CTRI/2019/02/017607 [Registered on: 12/02/2019] Trial Registered Prospectively |
| Last Modified On: |
10/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological |
| Study Design |
Other |
|
Public Title of Study
|
Usefulness of skin injections of platelet rich plasma in the treatment of melasma |
|
Scientific Title of Study
|
Role of platelet rich plasma therapy as an adjuvant in treatment of melasma |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bikash Chingshubam |
| Designation |
Postgraduate resident department of dermatology |
| Affiliation |
Delhi university |
| Address |
Room 713
Dermatology opd 7th floor
Lok nayak hospital
Bahadur Shah Zafar Marg,Delhi
Bahadur Shah Zafar Marg,Delhi
Central
DELHI
110002
India |
| Phone |
8929280690 |
| Fax |
|
| Email |
bikashching@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rashmi Sarkar |
| Designation |
Professor department of dermatology |
| Affiliation |
Delhi university |
| Address |
Gate no. 2
Skin Ward 22/23 dermatology department
Lok nayak hospital
Bahadur Shah Zafar Marg,Delhi
Central
DELHI
110002
India |
| Phone |
00919818244340 |
| Fax |
|
| Email |
rashmisarkar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Bikash Chingshubam |
| Designation |
Postgraduate resident department of dermatology |
| Affiliation |
Delhi university |
| Address |
Room 713
Dermatology opd 7th floor
Lok nayak hospital
Bahadur Shah Zafar Marg,Delhi
Central
DELHI
110002
India |
| Phone |
8929280690 |
| Fax |
|
| Email |
bikashching@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dermatology department
Lok nayak hospital
New delhi |
|
|
Primary Sponsor
|
| Name |
Chingshubam Bikash Singh |
| Address |
Room 44
Pg mens hostel
Opp central library
MAMC campus
New delhi |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Chingshubam bikash singh |
Lok nayak hospital |
7th floor skin opd
New Opd block
Central
DELHI |
8929280690
bikashching@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee MAMC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L814||Other melanin hyperpigmentation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Normal saline and hydroquinone |
Normal saline microinjections to the randomly selected side of the face with melasma and hydroquinone application on both sides of the face |
| Intervention |
Platelet rich plasma and hydroquinone |
Microinjections of platelet rich plasma to the randomly selected side of the face with melasma and
Hydroquinone application on both sides of the face |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed clinically with melasma
Patients more than 18 years of age of both sexes |
|
| ExclusionCriteria |
| Details |
Pregnant and lactating women
Women on oral contraceptives
Depigmenting treatment in the past 1 month
Active facial skin infection |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Efficacy of platelet rich plasma therapy with hydroquinone versus hydroquinone alone in patients of melasma |
Better improvement in modified melasma area severity index with platelet rich plasma and hydroquinone combonation at the end of 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Patients satisfaction with PRP therapy and hydroquinone versus hydroquinone alone |
Better patient satisfaction with PRP and hydroquinone combination therapy at the end of 3 months |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
15/02/2019 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
|
The primary purpose of my thesis is to study the adjuvant effect of platelet rich plasma microinjections in the treatment of melasma using a split face method. The outcomes will be evaluated using the modified melasma area severity index on each side of the face. The study hypothesis is that the side of the face treated with both hydroquinone local applications and PRP microinjections will show a significantly better improvement in MASI score then the side of the face treated with only hydroquinone local applications. |