| CTRI Number |
CTRI/2019/07/020190 [Registered on: 15/07/2019] Trial Registered Prospectively |
| Last Modified On: |
04/09/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
This study is to treat the melasma (black spots on face by giving intralesional tranexamic acid for treatment of melasma in male patients |
|
Scientific Title of Study
|
To study the efficacy and safety of intralesional tranexamic acid for treatment of melasma in male patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Yog Raj |
| Designation |
Junior resident |
| Affiliation |
Dr RPGMC TANDA KANGRA |
| Address |
Deptt of dermatology Dr RPGMC TANDA kangra Himachal Pradesh
Himachal Pradesh
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9816930531 |
| Fax |
|
| Email |
dryrv1983@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr VK mahajan |
| Designation |
Prof. and head |
| Affiliation |
Dr RPGMC TANDA KANGRA |
| Address |
Deptt of dermatology Dr RPGMC TANDA kangra Himachal Pradesh
Himachal Pradesh
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9816930531 |
| Fax |
|
| Email |
vkm1@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Yog Raj |
| Designation |
Junior resident |
| Affiliation |
Dr RPGMC TANDA KANGRA |
| Address |
Deptt of dermatology Dr RPGMC TANDA kangra Himachal Pradesh
Himachal Pradesh
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9816930531 |
| Fax |
|
| Email |
dryrv1983@gmail.com |
|
|
Source of Monetary or Material Support
|
| Govt. Of Himachal Pradesh via Dr RPGMC TANDA kangra |
|
|
Primary Sponsor
|
| Name |
Himachal Pradesh university |
| Address |
Summer hill Shimla 5 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr RPGMC TANDA |
Kangra Himachal Pradesh |
| NIL |
NIL |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Yog Raj |
Department of dermatology room number 135 Dr Rajender prashad govt medical collage hospital TANDA |
Kangra Himachal Pradesh pin code 176001
Kangra
HIMACHAL PRADESH |
9816930531
dryrv1983@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee Dr. RPGMC TANDA KANGRA |
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 |
| Intervention |
Intralesional tranenexamic acid 25mg/ml will be given to all the randomised patients on the lesions of melasma on the interval of 4week total 4 dosage... |
Outcome to be assessed at 6weeks for the total reduction of MASI score |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Male |
| Details |
Healthy volunteer |
|
| ExclusionCriteria |
| Details |
1 patient with realistic expectations 2 female, 3 bleeding disorders, 4 using any other treatment modalities for melasma in previous 6 months |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Total reduction in Melasma area severity index,at 4,8,12,16 week |
16 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| MASI score at 16 weeks |
At 4weeks interval for 4 times total for sixteen Weeks |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="58" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
26/07/2019 |
| Date of Study Completion (India) |
30/06/2020 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Not published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
I am going to treat the patient of melasma (only male volunteer) for this study by giving intralesional tranexamic acid injections in the strength of 25mg/ml with maximum number of patients 50. Objective of the study is to evaluate the safety ,efficacy and adverse effects of intralesional tranexamic acid for the treatment of melasma in male patients. Total of 35 patients has been registered till date. |