| CTRI Number |
CTRI/2016/05/006965 [Registered on: 26/05/2016] Trial Registered Prospectively |
| Last Modified On: |
25/05/2016 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmetic] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To determine the efficacy of sunscreens in the treatment of melasma as assessed(measured) by Melasma Quality of life |
|
Scientific Title of Study
|
To determine the efficacy of sunscreens in the treatment of melasma as assessed by MASI and Hindi Melasma Quality Of Life Index |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rashmi Sarkar |
| Designation |
Professor of Dermatology |
| Affiliation |
Maulana Azad Medical College and Lok Nayak Hospital |
| Address |
Dept of Dermatology
Maulana Azad Medical College
2-Bahadur Shah Zafar Marg
New Delhi-110002
Central
DELHI
110002
India |
| Phone |
9818244340 |
| Fax |
|
| Email |
rashmisarkar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rashmi Sarkar |
| Designation |
Professor of Dermatology |
| Affiliation |
Maulana Azad Medical College and Lok Nayak Hospital |
| Address |
Dept of Dermatology
Maulana Azad Medical College
2-Bahadur Shah Zafar Marg
New Delhi-110002
Central
DELHI
110002
India |
| Phone |
9818244340 |
| Fax |
|
| Email |
rashmisarkar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rashmi Sarkar |
| Designation |
Professor of Dermatology |
| Affiliation |
Maulana Azad Medical College and Lok Nayak Hospital |
| Address |
Dept of Dermatology
Maulana Azad Medical College
2-Bahadur Shah Zafar Marg
New Delhi-110002
Central
DELHI
110002
India |
| Phone |
9818244340 |
| Fax |
|
| Email |
rashmisarkar@gmail.com |
|
|
Source of Monetary or Material Support
|
| IADVL Loreal Hair and Skin Research Grant 2016 |
|
|
Primary Sponsor
|
| Name |
Indian Association of Dermatologists Venereologists and LeprologistsIADVL |
| Address |
IADVL National Headquarters
4772-73 Pvt No,T3 and T4,3rd Floor,
23,Bharat Ram Road,Darya Ganj,New Delhi-110002 |
| Type of Sponsor |
Other [Association of Dermatologists in India] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Loreal |
LOreal Indian PVT LTD
7th Floor universal majestic,
Ghatkopar- Mankhurd Link road,
Chembur, Mumbai - 400071
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rashmi Sarkar |
Maulana Azad Medical College and Lok Nayak Hospital,New Delhi |
Dept of Dermatology
Maulana Azad Medical College and Lok Nayak Hospital
7th Floor Surgical Block
2- Bahadur Shah Zafar Road
New Delhi-110002
North West
DELHI |
9819244340
9818244340
rashmisarkar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maulana Azad Medical College and LN Hospital,GB Pant Hospital and Guru Nanak Eye Centre New Delhi Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Melasma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Garnier White complete stearate gel |
TOPICAL, ONCE FOR FITEEN DAYS |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with clinical diagnosis of Melasma.
2. Naïve patients, not on any therapy.
|
|
| ExclusionCriteria |
| Details |
1. Age less than 20 years.
2. History of intake of Oral contraceptives
3. History of photosensitivity
4. Pregnant/nursing patient
5. Patient taking photosensitizing medications
6. Family history of melasma
7. Thyroid abnormality
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Sunlight has been proposed as one of the most important triggering event in the etiopathogenesis of melasma. However there are very few studies that evaluate its role in the treatment of melasma. Also, the impact of melasma and its treatment on the quality of life has assessed by the Hindi Melasma Quality Of Life Index has not been assessed before in the Indian setup. |
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe tolerability to sunscreen of the patients over 12 weeks |
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
11/07/2016 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
1.1 . Sheth VM, Pandya AG.Melasma: a comprehensive update: part I. J Am Acad Dermatol. 2011 Oct;65(4):689-97.
4 Benchikhi H, Razoli H, Lakhdar H. Sunscreens: use in pregnant women in Casablanca.
Ann Dermatol Venereol 2002; 129: 387–390.
10. Balkrishnan R, McMichael AJ, Camacho FT, et al. Development and validation of a health-related quality of life instrument for women with melasma. Br J Dermatol 2003;149:572–7.
11. Sarkar R, Garg S, Dominguiz A, Balkrishanan R, Jain RK, Panday AG. Development and validation of a Hindi language health-related quality of life questionnaire for melasma in Indian patients. Indian J Dermatol Venereol Leprol. Jan 2016 press.
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Sunlight has always been considered an important triggering factor in the pathogenesis of melasma and sunscreens are considered mainstay of treatment of melasma.However,there are hardly any studies from India or Asia evaluating the role of sunscreens in the treatment of melasma or its effect on the Melasma Quality of Life of the patients.This study is a single arm interventional study which has been undertaken on 100 Indian patients of melasma to evaluate the effectiveness of a broad band sunscreen in the treatment of melasm alone in Indian patients over a period of 12 weeks using the validated Hindi Melasma Quality of Life(Hindi MELASQOL )on patients.,which will be the primary outcome on patients.The secondary outcome would be evaluation of tolerability of the sunscreen in the treatment of melasma in Indian patients.A correlation of MASI(melasma area and severity index) and Hindi MELASQOL will also be done in the patients.Before and after photography will also be done in patients to assess treatment. |