| CTRI Number |
CTRI/2019/07/020435 [Registered on: 30/07/2019] Trial Registered Prospectively |
| Last Modified On: |
29/07/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Biological |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study comparing Platelet Rich Plasma with THBG in patients of melasma |
|
Scientific Title of Study
|
Double ARM Randomised Controlled Study Comparing the Efficacy of Platelet Rich Plasma and Local Application of 2% THBG (Alpha Glucoside Derivative of Trihydroxy Benzoic Acid) in Patients with Facial Melasma. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Milan Jhavar |
| Designation |
Dermatology resident 1st year |
| Affiliation |
government medical college bhavnagar |
| Address |
Opd Room no 115,1st floor,Sir T Hospital, Government medical College, kalanala Bhavnagar
Bhavnagar
GUJARAT
346001
India |
| Phone |
9998534301 |
| Fax |
02782422011 |
| Email |
jhavarmilan@yahoo.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Hita Mehta |
| Designation |
Professor and Head of department of dermatology(thesis guide) |
| Affiliation |
government medical college bhavnagar |
| Address |
opd 115,sir t hospital, government medical college bhavanagar
201,golden arc apartment,ata bhai chowk,bhavnagar
Bhavnagar
GUJARAT
346001
India |
| Phone |
9429503188 |
| Fax |
02782422011 |
| Email |
hitamehta88@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Milan Jhavar |
| Designation |
Dermatology Resident 1st year |
| Affiliation |
Government Medical College Bhavnagar |
| Address |
Opd 115 ,1st floor ,sir t hospital, government medical college bhavanagar
Bhavnagar
GUJARAT
346001
India |
| Phone |
9998534301 |
| Fax |
02782422011 |
| Email |
Jhavarmilan@yahoo.in |
|
|
Source of Monetary or Material Support
|
| OPD 115,Department of Dermatology Sir T Hospital; Bhavnagar,Government Medical College Bhavnaagr,pin 346001 |
|
|
Primary Sponsor
|
| Name |
Government medical college bhavnagar |
| Address |
Opd 115,sir t hospital, department of dermatology |
| 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 |
| MilanJhavar |
sir t hospital |
opd 115 sir t hospital bhavnagar, Government medical college bhavnagar
Bhavnagar
GUJARAT |
9998534301
02782422011
jhavarmilan@yahoo.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IRB govt medical college bhavnagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L80-L99||Other disorders of the skin and subcutaneous tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
platelet rich plasma mesotherapy |
prp injected till papillary dermis 1.5 ml at 3-4 sites of melasma on three seatings at interval of 3 months |
| Comparator Agent |
thba2%w/w |
application of thba 2%w/w once a night for 3 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
patients with age above 18 years irrespective of their sex clinically diagnosed melasma will be included in study
.
|
|
| ExclusionCriteria |
| Details |
Females on oral contraceptive pill
Age <18 years
Pregnant female
Tendency for keloid, hypertrophic scar
Bleeding disorder
Platelet abnormality
On anticoagulant drugs
Chronic liver disease
On oral tretinoin
Refusal to allow photographs
hiv/hbsag +ve |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Modified melasma area severity index
Physician global assessment scale
Patients global assessment scale
MelasQOL(melasma quality of life)
dermoscope |
after 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
dermoscopic and woods lamp dignosis of melasma
improvement in masi and melaqol
efficasy and safety of boyh modalities |
after 4th week,8th week and 12th week of starting of procedure |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
01/08/2019 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Melasma is the most common cause of facial melanosis and is manifested by hyperpigmented macules on the face which become more pronounced after sun exposure Transforming growth factor Beta 1(TGF B1) is present in Alfa granules of platelets It is known to decrease melanogenesis via delayed extracellular signal-regulated kinase activation Thba Controls NF-kB pathway Reduces PGE2 expression Prevents melanin transfer to keratinocytes Inhibits Tyrosinase
|