| CTRI Number |
CTRI/2026/03/106586 [Registered on: 19/03/2026] Trial Registered Prospectively |
| Last Modified On: |
20/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmetic] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study to Evaluate the Safety and Effectiveness of a Skin Care Product for Reducing Pores, Acne, and Oiliness. |
|
Scientific Title of Study
|
To evaluate the safety and efficacy of skin care formulation in terms of reduction in pore appearance acne and reduction in sebum on healthy male and female subjects |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| XXX-ZF01-IW-FR26; Version: 01; Dated: 04/03/2026 |
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
|
| Bio Veda Farmacy Private Limited First Floor, Khasra No. 439/42,441/43,526/442/43, Mauja Rampur Ghat, Sirmaur, Himachal Pradesh, 173025 |
|
|
Primary Sponsor
|
| Name |
Bio Veda Farmacy Private Limited |
| Address |
First Floor, Khasra No. 439/42,441/43,526/442/43, Mauja Rampur Ghat, Sirmaur, Himachal Pradesh, 173025 |
| 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
Modification(s)
|
| 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 |
having mild to moderate acne, visible pores and oily to mixed oily skin type |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NEEM FACE WASH |
Product is applied on the whole face two times in a day for the period of 28 days. |
| Comparator Agent |
Nil |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1.Indian male & female subjects
2.Healthy subjects
3.Skin is healthy on the studied anatomic unit
4.having mild to moderate acne, visible pores and oily to mixed oily skin type |
|
| ExclusionCriteria |
| Details |
1 For female:- 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 |
| Reduction in pore appearance acne and reduction in sebum |
Baseline, 30 minutes after application, Day 7, Day 14, Day 28 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in acne lesion count, Acne Severity Index, acne size & redness |
Baseline, 30 minutes after application, Day 7, Day 14, Day 28 |
|
|
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)
|
28/03/2026 |
| 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="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
|
OBJECTIVE
·
Primary Objective
The objective of this study is
to evaluate the safety and efficacy of skin care formulation in terms of reduction
in pore appearance acne and reduction in sebum on healthy male and female
subjects.
·
Secondary Objective
Secondary objective is to evaluate the in-vivo
efficacy of a skin care formulation in terms of Reduction in acne lesion count,
Acne Severity Index, acne size & redness on healthy male and female
subjects.
The evaluation will be performed using: Subject Self Evaluation (SSE), Dermatological Evaluation:
Cosmetic Acceptability, Dermatological Evaluation: Efficacy, Sebumetry, Antera
3D, Digital Photographs
POPULATION
36 (18 males & 18 females)
will be selected for the study.
The subjects selected for
this study will be healthy male & females, aged between 18 and 30 years, having mild to moderate acne,
visible pores and oily to mixed oily skin type.
STUDY DURATION: 28 days
following the first application of the product.
|