| CTRI Number |
CTRI/2026/01/101439 [Registered on: 19/01/2026] Trial Registered Prospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmetic] |
| Study Design |
Other |
|
Public Title of Study
|
Study on the Safety and Effectiveness of a cosmetic product |
|
Scientific Title of Study
|
To evaluate safety and efficacy of skin care formulations in terms of non comedogenic effect on healthy human female subjects. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| XXX-2F13-AZ-DR25; Version: 01; Dated: 26/12/2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Niharika Salian |
| 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 |
niharika@mascotspincontrol.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Niharika Salian |
| 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 |
niharika@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
|
| Amvigor Organics Pvt Ltd
1311-1317,1401,1403,1405,1407,1411-1420,
13th and 14th Floor,
The Gateway Atmosphere, Mulund Goregaon Link Road,
Mumbai, Mumbai Suburban,
Maharashtra, Pin code- 400080.
|
|
|
Primary Sponsor
|
| Name |
Amvigor Organics Pvt Ltd |
| Address |
1311-1317,1401,1403,1405,1407,1411-1420,
13th and 14th Floor,
The Gateway Atmosphere, Mulund Goregaon Link Road,
Mumbai, Mumbai Suburban,
Maharashtra, Pin code- 400080.
|
| Type of Sponsor |
Other [Personal Care or Beauty 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 Niharika Salian |
Mascot Spincontrol India Pvt. Ltd. |
Sea Breeze Building, 9th Floor, Appasaheb Marathe Marg, Century Bazaar, Prabhadevi, Mumbai, Maharashtra
Mumbai
MAHARASHTRA |
02243349191
niharika@mascotspincontrol.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethos- Institutional Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
presenting oily or mixed oily skin on the face |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cutibrite Serum Gel |
Product is applied on the whole face once in a day for the period of 28 days. |
| Comparator Agent |
Nil |
NA |
| Intervention |
Physical Sunscreen |
Product is applied on the whole face once in a day for the period of 28 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1.Indian female subjects.
2.Healthy subjects
3.Skin is healthy on the studied anatomic unit
4.Having mixed oily or oily skin on the face (visual assessment by dermatologist). |
|
| 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 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,
antihistamines, 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 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 and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Non-comedogenic effect |
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
|
N/A |
|
Date of First Enrollment (India)
|
27/01/2026 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
OBJECTIVE:The objective of this study will be to evaluate the safety and efficacy of skin care formulations in terms of non-comedogenic effect on healthy human female subjects
The evaluation is performed using: Subject Self Evaluation (SSE), Dermatological Evaluation: Cosmetic Acceptability, Dermatological Evaluation: Efficacy POPULATION:72 female subjects will be selected for this study.The subjects selected for this study will be healthy females aged between 18 to 35 years, having oily to mixed oily skin type STUDY DURATION: 28 days following the application of the product.
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