| CTRI Number |
CTRI/2024/12/078257 [Registered on: 17/12/2024] Trial Registered Prospectively |
| Last Modified On: |
06/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmeceuitcal] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Testing the Effect of a Skincare Product on Melasma in Healthy Individuals |
|
Scientific Title of Study
|
The objective of this study will be to evaluate the in vivo safety and efficacy of skin care formulation in terms of reduction in melasma on healthy human subjects |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| XXX-QF03-XK-OR24; Version: 01; Dated: 19/11/24 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pooja Yadav |
| Designation |
Principal Investigator |
| Affiliation |
MASCOT-SPINCONTROL India Pvt. Ltd. |
| Address |
Sea Breeze Building, 9th Floor, Appasaheb Marathe Marg, Century Bazaar, Prabhadevi, Mumbai, Maharashtra
Mumbai
MAHARASHTRA
400025
India |
| Phone |
02243349191 |
| Fax |
|
| Email |
poojayadav@mascotspincontrol.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pooja Yadav |
| Designation |
Principal Investigator |
| Affiliation |
MASCOT-SPINCONTROL India Pvt. Ltd. |
| Address |
Sea Breeze Building, 9th Floor, Appasaheb Marathe Marg, Century Bazaar, Prabhadevi, Mumbai, Maharashtra
MAHARASHTRA
400025
India |
| Phone |
02243349191 |
| Fax |
|
| Email |
poojayadav@mascotspincontrol.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mohit Lalvani |
| Designation |
Study Director |
| Affiliation |
MASCOT-SPINCONTROL India Pvt. Ltd. |
| Address |
Sea Breeze Building, 9th Floor, Appasaheb Marathe Marg, Century Bazaar, Prabhadevi, Mumbai, Maharashtra
Mumbai
MAHARASHTRA
400025
India |
| Phone |
02243349191 |
| Fax |
|
| Email |
mohit.CTRI@gmail.com |
|
|
Source of Monetary or Material Support
|
| Glenmark Pharmaceuticals Ltd.
Corporate Enclave, 2nd Floor,
B D Sawant Marg, Chakala,
Off western Express Highway,
Andheri (East), Mumbai – 400099 |
|
|
Primary Sponsor
|
| Name |
Glenmark Pharmaceuticals Ltd. |
| Address |
Corporate Enclave, 2nd Floor, B D Sawant Marg, Chakala, Off western Express Highway, Andheri (East), Mumbai – 400099 |
| 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 Pooja Yadav |
MASCOT-SPINCONTROL India Pvt. Ltd. |
Sea Breeze Building, 9th Floor, Appasaheb Marathe Marg, Century Bazaar, Prabhadevi, Mumbai, Maharashtra
Mumbai
MAHARASHTRA |
02243349191
poojayadav@mascotspincontrol.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Suraksa- Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Subjects having Melasma (ICD10- L81-Other disorder of Pigmentation, L81 1-CHloasma) |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cysteamine, Alpha Arbutin, Niacinamide, Tamarindus Indica Cream |
The Product is applied on melasma patches on face once in night for the period of 112 days. |
| Comparator Agent |
Nil |
NA |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Indian Male and Female subjects
2. Healthy subjects
3. Skin is healthy on the studied anatomic unit
4. Human subjects with melasma
|
|
| ExclusionCriteria |
| Details |
1. Being pregnant or breastfeeding or having stopped to breastfeed in the past three months.
2. Having refused to give her assent by not signing the consent form.
3. Taking part in another study liable to interfere with this study.
4. Being insulin-dependent diabetic or non-insulin-dependent diabetic with a recent therapy (less than 6 months)
5. Having progressive asthma.
6. Being epileptic.
7. Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months)
8. Having cutaneous hypersensitivity
9. Having a diagnosed or highly probable allergy to one or several compounds of cosmetic products.
10. Following a chronic medicinal treatment comprising any of the following products: aspirin-based products, anti-inflammatories, anti-histamines, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol)
11. Having consumed caffeine-based products (coffee, cola, tea …), alcohol, highly spiced foods and/or smoked in the two hours preceding the measurements.
12. Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months.
13. Having changed her cosmetic habits in the 14 days preceding the start of the study on the studied anatomic unit
14. Having applied a cosmetic product (included make-up) or skin care product on the studied areas the day of the study (only face cleaned with water is accepted) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in melasma |
Baseline, 28 days, 56 Days, 84 Days, 112 Days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in pigmentation, change in MELASQOL (quality of lifestyle) related to melasma, Cosmetic Acceptability |
Baseline, 28 days, 56 Days, 84 Days, 112 Days |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
23/01/2025 |
| 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="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
PRIMARY
OBJECTIVE
The
objective of this study will be to evaluate
the in vivo safety and efficacy of skin care formulation
in terms of reduction in melasma on
healthy human subjects.
SECONDARY
OBJECTIVE
The
objective of this study will be to
evaluate change in pigmentation, change in MELASQOL (quality of lifestyle)
related to melasma, Cosmetic Acceptability on healthy human
subjects.
The
evaluation is performed using Dermatological
Evaluation: Efficacy, Mexametry, Dermatological Evaluation: Cosmetic
Acceptability, Subject Self Evaluation
The
study lasts for 112 days following the first application of the product.
POPULATION : 36
(18 Females & 18 Males) subjects will
be selected for the study.
The subjects
selected for this study will be healthy males and females aged 30
to 60 years, having melasma.
STUDY DURATION
Duration: 112 days following the first
application of the product. |