| CTRI Number |
CTRI/2025/01/079448 [Registered on: 24/01/2025] Trial Registered Prospectively |
| Last Modified On: |
17/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmeceuitcal] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Safety and efficacy check of products |
|
Scientific Title of Study
|
The objective of this study will be to evaluate the in vivo safety and efficacy of a skin care formulation in terms of reduction in appearance of cellulite on healthy female |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| XXX-AC01-XC-DR24; Version: 01; Dated: 27/12/2024 |
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
|
| VLCC Personal care Ltd.
Magnum City Centre,
Near Birla Navya Township,
Sector-63A,
Gurugram, Haryana 122011 |
|
|
Primary Sponsor
|
| Name |
VLCC Personal care Ltd. |
| Address |
Magnum City Centre, Near Birla Navya Township, Sector-63A, Gurugram, Haryana 122011 |
| Type of Sponsor |
Other [Cosmetic/Personal Care Industry] |
|
|
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 |
| Ethos- An Institutional Ethics committee (Mumbai) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
having cellulite on the upper arms, belly & thighs |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
NA |
| Intervention |
VL CL PCRGEL |
Product to be applied on both Thighs, Both Upper Arms & Belly Area. Application will be twice in a day for the period of 45 days. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
1)Indian / Asian female subjects
2)Healthy subjects
3)Skin is healthy on the studied anatomic unit
4) Having cellulite on the upper arms, belly and thighs visible with the naked eye |
|
| ExclusionCriteria |
| Details |
1)For Females: Being pregnant or breastfeeding or having stopped to breastfeed in the past three months.
2)Having refused to give his/her assent by not signing the consent form
3)Taking part in another study liable to interfere with this study
4)Having a chronic dermatosis liable to modify the cutaneous
reactivity on the tested area
5)Being insulin-dependent diabetic or non insulin-dependent diabetic
with a recent therapy (less than 6 months)
6)Having a progressive asthma (either under treatment or last fit in the last 2 years)
7)Being epileptic
8)Having non stabilized thyroid problems (requirement of a stabilized
treatment for at least 6 months)
9)Having cutaneous hypersensitivity
10)Having a diagnosed or highly probable allergy to one or several
compounds of the cosmetic products
11)Following a chronic or intermittent medicinal treatment comprising
any of the following products: aspirin-based products,
anti-inflammatories, antihistamines, anti-coagulants, corticotherapy,
taken by general or local routes (the only medication permitted is paracetamol)
12)Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in appearance of cellulite |
Baseline, Day 14, Day 28, Day 45 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
NA |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "36"
Final Enrollment numbers achieved (India)="36" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
28/01/2025 |
| Date of Study Completion (India) |
17/03/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
OBJECTIVE:
The objective of this study will be to evaluate the in vivo safety and efficacy
of a skin care formulation in terms of reduction in appearance of cellulite on
healthy female subjects
The
evaluation is performed using: Subject Self Evaluation, Dermatological
Evaluation (Cosmetic Acceptability), Visual Grading of Cellulite
POPULATION:
36 Female subjects are selected for the study.
The
subjects selected for this study will be healthy females, aged between 25 and
50 years, having cellulite on the upper arms, belly & thighs visible with
the naked eye with a grade higher or equal to 3.
STUDY
DURATION: 45 days following the first application of the product.
STUDY DESIGN:
Single blind study, Non-comparative study, Subjects do not serve as their own
references |