| CTRI Number |
CTRI/2018/01/011403 [Registered on: 18/01/2018] Trial Registered Prospectively |
| Last Modified On: |
28/08/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
To study "Quality of Life" and untoward effects of TRI-LUMA Cream in women with melasma on face. |
|
Scientific Title of Study
|
Evaluation of “Quality of Life†and in-use tolerance in women with facial melasma, after using a triple combination drug (TRI-LUMA Cream) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CL/060/1117/STU |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajiv Joshi |
| Designation |
Principal Investigator |
| Affiliation |
C.L.A.I.M.S. PVT.LTD |
| Address |
C.L.A.I.M.S. PVT.LTD
4th floor, B wing,
Modi House, C 10,
Dalia Industrial Estate,
New Link Road, Andheri(W)
4th floor, B wing,
Modi House, C 10,
Dalia Industrial Estate,
New Link Road, Andheri(W)
Mumbai
MAHARASHTRA
400058
India |
| Phone |
66758851 |
| Fax |
66758854 |
| Email |
rsjdr@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Swapnil Deshpande |
| Designation |
Manager Medical & Regulatory Affairs |
| Affiliation |
Galderma India Private Limited |
| Address |
Galderma India Private Limited
8th Floor, D Wing, Unit 801 & 802,
Lotus Corporate Park,
Off Western Express Highway
Goregaon (East), Mumbai
8th Floor, D Wing, Unit 801 & 802,
Lotus Corporate Park,
Off Western Express Highway
Goregaon (East), Mumbai
Mumbai
MAHARASHTRA
400063
India |
| Phone |
8691031041 |
| Fax |
|
| Email |
Swapnil.DESHPANDE@galderma.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amanjit Kaur Ahluwalia |
| Designation |
Sr. Manager Medical and Regulatory, R&A |
| Affiliation |
Galderma India Private Limited |
| Address |
Galderma India Private Limited
8th Floor, D Wing, Unit 801 & 802,
Lotus Corporate Park,
Off Western Express Highway
Goregaon (East), Mumbai
8th Floor, D Wing, Unit 801 & 802,
Lotus Corporate Park,
Off Western Express Highway
Goregaon (East), Mumbai
Mumbai
MAHARASHTRA
400063
India |
| Phone |
40331818 |
| Fax |
|
| Email |
AmanjitKaur.AHLUWALIA@galderma.com |
|
|
Source of Monetary or Material Support
|
| Galderma India Private Limited
8th Floor, D Wing, Unit 801 & 802,
Lotus Corporate Park, Off Western Express Highway
Goregaon (East), Mumbai: 400063
Tel: 022-40331818 |
|
|
Primary Sponsor
|
| Name |
Galderma India Private Limited |
| Address |
8th Floor, D Wing, Unit 801 & 802,
Lotus Corporate Park, Off Western Express Highway
Goregaon (East), Mumbai: 400063 Tel: 022-40331818 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
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 Rajiv Joshi |
C.L.A.I.M.S. PVT.LTD |
4th floor, B wing,
Modi House, C-10, Dalia Industrial Estate,
New Link Road, Andheri(W), Mumbai-400058,
Tel:91-22-66758851
Mumbai
MAHARASHTRA |
22-66758851
rsjd@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INDEPENDENT ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
with moderate to severe melasma on the face |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Triple combination drug (TRI-LUMA Cream) |
Approximately 0.2 gms to be applied evenly to form a thin film on the affected area, once at night for 2 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
Participants with moderate to severe melasma on the face.
Childbearing potential patient with highly effective contraceptive methods
Willing to avoid unusual sun exposure as far as possible for the entire study duration.
|
|
| ExclusionCriteria |
| Details |
Patients with prior history of mometasone based triple combination melasma therapy or under hormonal replacement therapy including usage of OC pills
If Patients were immunocompromised or were under immunosuppressive treatment, or had contraindications for corticosteroid treatment
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Quality of life and Participant Satisfaction |
Day 0, 1 month, 2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Clinical evaluation of skin atrophy |
Day 0, 1 month, 2 months |
| Non-invasive Ultrasound biomicroscopy (UBM) of the skin |
Day 0, 1 month, 2 months |
| Clinical evaluation for in use tolerance |
Day 0, 1 month, 2 months |
| Subjective self-assessment for in use tolerance |
Day 0, 1 month, 2 months |
| Percent Changes in MASI score |
Day 0, 1 month, 2 months |
| Instrumental evaluation for color |
Day 0, 1 month, 2 months |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
Final Enrollment numbers achieved (Total)= "33"
Final Enrollment numbers achieved (India)="33" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
05/02/2018 |
| Date of Study Completion (India) |
19/04/2018 |
| 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
Modification(s)
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
At the
end of study,
Based on Participant
Quality of life questionnaire and Satisfaction questionnaire it can be
concluded that Test Product: TRI-LUMA Cream - Batch No.: GF01 used along with
Cetaphil Daylong SPF 50+ PA+++ Light Gel - B. No: V132 Helped in improving the Quality of Life for melasma condition which was
agreed upon by more than 90% of participants. More than 50% of participants were overall satisfied with the treatment
Based on Instrumental
evaluation Significant reduction in amount of melanin present on the facial skin Significant lightening of pigmented area
Based on Non-invasive
Ultrasound biomicroscopy Significant reduction in Epidermal entry echo Significant reduction in skin thickness Significant reduction in Subepidermal Hypoechoic band thickness
Based on Clinical
evaluation Significant reduction in melasma
Based on clinical
and subjective self-evaluation TRI-LUMA Cream was very well tolerated by all
participants |