| CTRI Number |
CTRI/2024/08/071856 [Registered on: 02/08/2024] Trial Registered Prospectively |
| Last Modified On: |
31/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmeceuitcal ] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of products on pimples |
|
Scientific Title of Study
|
To evaluate and compare the in-vivo safety and efficacy of the skin care formulations in terms of reduction in Acne (live/occurring) on healthy female subjects |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| XXX-ZF01-CJ-MY24; Version: Final 01; 09/07/2024 |
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
|
| Cureskin
Ground Floor, 171,
HSIDC, Sector 2, Saha,
Amabala. Haryana – 133104 |
|
|
Primary Sponsor
|
| Name |
Cureskin |
| Address |
Ground Floor, 171,
HSIDC, Sector 2, Saha,
Amabala. Haryana – 133104 |
| Type of Sponsor |
Other [FMCG] |
|
|
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
mild to moderate acne and oily to mixed oily skin type |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
NA |
| Intervention |
Regime 1 |
Regime consisted of 4 products, all the products will be applied on whole face for the period of 28days. |
| Intervention |
Regime 2 |
Regime consisted of 4 products, all the products will be applied on whole face for the period of 28days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Female |
| Details |
1. Indian female subjects
2. Healthy subjects
3. Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar….)
4 Having mild to moderate acne and oily to mixed oily skin type |
|
| ExclusionCriteria |
| Details |
1. Being pregnant or breastfeeding or having stopped to breastfeed in the past three months
2. Having refused to give her/his 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 a progressive asthma (either under treatment or last fit in the last 2 years)
6. Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area (except for specific studies on a determined dermatosis)
7. Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months)
8. Being epileptic.
9. 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)
10. Having cutaneous hypersensitivity.
11. Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products.
12. Having undergone a surgery requiring a general anesthetic of more than one hour in the past 6
months. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in Acne |
Baseline, Day 14, Day 28 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
NA |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
11/08/2024 |
| 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="3"
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
|
The objective of this study will be to evaluate and
compare the in-vivo safety and efficacy of the skin care formulations in terms
of reduction in Acne (live/occurring) on healthy female subjects.
Products: Regime1 and Regime 2
The evaluation is performed using: Subject Self
Evaluation (SSE), Dermatological :
Cosmetic Acceptability, Dermatological Evaluation: Efficacy
The study lasts 28 days following the first application
of the regime on whole face.
POPULATION - 72 Females subjects will be selected for the
study.
The subjects selected for this study are healthy females,
aged between 18 and 30 years, having mild to moderate acne and oily to mixed
oily skin type.
The study will be conducted in 2 groups.
I. Group A: This group will include 36 female subjects
using Regime 1.
II. Group B: This group will include 36 female subjects
using Regime 2. |