| CTRI Number |
CTRI/2020/04/024630 [Registered on: 14/04/2020] Trial Registered Prospectively |
| Last Modified On: |
01/08/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
To study impact of darkening of face on life of affected patients |
|
Scientific Title of Study
|
To study quality of life in cases of facial hyperpigmentation |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 1256, Version 1 dated 19/12/2018 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sanjeev Gupta |
| Designation |
Professor and Head |
| Affiliation |
Maharishi Markandeshwar Institute of Medical Sciences and Research |
| Address |
Room No. 212, OPD Complex, Department of
Dermatology, Maharishi Markandeshwar Institute of Medical
Sciences and Research, Mullana, Ambala
Ambala
HARYANA
133207
India |
| Phone |
9812017161 |
| Fax |
|
| Email |
sanjeevguptadr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjeev Gupta |
| Designation |
Professor and Head |
| Affiliation |
Maharishi Markandeshwar Institute of Medical Sciences and Research |
| Address |
Room No. 212, OPD Complex, Department of
Dermatology, Maharishi Markandeshwar Institute of Medical
Sciences and Research, Mullana, Ambala
Ambala
HARYANA
133207
India |
| Phone |
9812017161 |
| Fax |
|
| Email |
sanjeevguptadr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjeev Gupta |
| Designation |
Professor and Head |
| Affiliation |
Maharishi Markandeshwar Institute of Medical Sciences and Research |
| Address |
Room No. 212, OPD Complex, Department of
Dermatology, Maharishi Markandeshwar Institute of Medical
Sciences and Research, Mullana, Ambala
Ambala
HARYANA
133207
India |
| Phone |
9812017161 |
| Fax |
|
| Email |
sanjeevguptadr@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maharishi Markandeshwar Institute of Medical Sciences and Research, Mullana, Ambala, Haryana, 133207 |
|
|
Primary Sponsor
|
| Name |
Maharishi Markandeshwar Institute of Medical Sciences and Research |
| Address |
Maharishi Markandeshwar Institute of Medical Sciences and Research, Mullana, Ambala, Haryana, 133207 |
| Type of Sponsor |
Private 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 Anuradha Yadav |
Maharishi Markandeshwar Institute of Medical Sciences and Research |
Room No. 211, 2nd
Floor, OPD Complex, Department of
Dermatology, Maharishi
Markandeshwar
Institution of Medical
Sciences, Mullana,
Ambala, 133207
Ambala
HARYANA |
9992185137
dranuradha.mmu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MM Institute of Medical Sciences and Research, Mullana, Ambala |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L819||Disorder of pigmentation, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients of either sex with clinical features of facial melanosis(face with or without neck involving more than 50% of area)
2) Patients in 18-60 years age group. |
|
| ExclusionCriteria |
| Details |
1) Patients below the age of 18 years and above age of 60 years.
2) Pregnant females. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Quality of life in patients of facial hyperpigmentation |
At the time of enrollment and 3 months later |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Clinical pattern in patients of facial hyperpigmentation |
At the time of enrollment and 3 months later |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/04/2020 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
|
Facial Melanoses (FM)
are a group of disorders which shares some clinical features of altered
pigmentation. It causes cosmetic defacement
and considerable psychological discomfort. The aim of this study is 1. To study clinical patterns of facial melanosis.
2) 2. To
study quality of life in facial melanosis. 3. To study dermatoscopic pattern of facial melanosis. This study will help us to know the impact of facial hyperpigmentation on a patient’s life.
|