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CTRI Number  CTRI/2023/02/049933 [Registered on: 21/02/2023] Trial Registered Prospectively
Last Modified On: 06/11/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Cosmaceutical]  
Study Design  Single Arm Study 
Public Title of Study   Safety and efficacy assessment of Product on skin  
Scientific Title of Study   To evaluate the in-vivo safety and efficacy of the skin care formulation in terms of reduction in acne severity, reduction in sebum and Acne PIH spot on healthy female & male subjects. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
XXX-ZF03-HA-JR23; Version: Final 01; Dated: 07/02/2023  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Raji Patil  
Designation  Investigator  
Affiliation  MASCOT-SPINCONTROL India Pvt. Ltd.  
Address  Kohinoor Estate,3rd Floor, Sun Mill Compound, Lower Parel West, Mumbai.
Kohinoor Estate,3rd Floor, Sun Mill Compound, Lower Parel West, Mumbai.
Mumbai
MAHARASHTRA
400013
India 
Phone  02243349191   
Fax    
Email  raji@mascotspincontrol.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Raji Patil  
Designation  Investigator  
Affiliation  MASCOT-SPINCONTROL India Pvt. Ltd.  
Address  Kohinoor Estate,3rd Floor, Sun Mill Compound, Lower Parel West, Mumbai.
Kohinoor Estate,3rd Floor, Sun Mill Compound, Lower Parel West, Mumbai.

MAHARASHTRA
400013
India 
Phone  02243349191   
Fax    
Email  raji@mascotspincontrol.in  
 
Details of Contact Person
Public Query  
Name  Dr Mohit Lalvani  
Designation  Study Director  
Affiliation  MASCOT-SPINCONTROL India Pvt. Ltd.  
Address  Kohinoor Estate,3rd Floor, Sun Mill Compound, Lower Parel West, Mumbai.
Kohinoor Estate,3rd Floor, Sun Mill Compound, Lower Parel West, Mumbai.
Mumbai
MAHARASHTRA
400013
India 
Phone  02243349191   
Fax    
Email  mohit.CTRI@gmail.com  
 
Source of Monetary or Material Support  
MASCOT-SPINCONTROL India Pvt. Ltd. 3rd Floor, Kohinoor Estate, Sun Mill compound, Lower Parel Mumbai (Suburban) MAHARASHTRA 400013 India 
 
Primary Sponsor  
Name  HONASA CONSUMER PVT LTD. (MAMAEARTH) 
Address  BLM Tower, 4th Floor, Plot no.63, Sector-44, Gurugram, Haryana, India-12003 
Type of Sponsor  Other [FMCG] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  Not applicable 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Raji Patil   Mascot Spincontrol India Pvt. Ltd.  Kohinoor Estate, 3rd Floor, Sun Mill Compound, Lower Parel West, Mumbai-400013
Mumbai
MAHARASHTRA 		 02243349191

raji@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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Volunteers with mild to moderate acne & mixed oily or oily skin type and having acne PIH dark spot 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Not Applicable  
Intervention  Salicylic acid and Niacinamide serum: Product A  Take approximately 2-3 drops of the product.Spread it all over the face in a circular motion. Apply the product twice a day in morning & at night on the whole face for a period of 28 days. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  The study will be conducted on subjects who will fulfill the following criteria:
1.Indian male and female subjects
2.Healthy subjects (no infectious and evolutive pathology which could make the subject
vulnerable and stop the study, no pathology which could interfere with the study, no
symptom in the process of an exploratory checkup)
3.Between 18 and 30 years of age.
4.Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory
scar….)
5.Having mild to moderate acne.
6.Having mixed oily or oily skin on the face.
7.Having acne PIH dark spot (with at least one dark spot >3.5 mm in diameter). 
 
ExclusionCriteria 
Details  1.For Females: 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 anaesthetic of more than one hour in the
past 6 months.
13.Having changed her/his cosmetic habits except those required by the protocol in the 14 days preceding the start of the study on the studied anatomic unit.
14.Having applied a cosmetic product (included make-up) on the studied areas the first day of
the study (only face cleaned with water is accepted)
15.Having applied hair oil during the entire duration of the study.
16.Refusing to follow the restrictions below during the study:
-Do not take part in any family planning activities leading to pregnancy and breastfeeding
-Do not take part in another study liable to interfere with this study
-Do not take 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).
-Do not change her/his cosmetic habits apart from the particular conditions mentioned in the protocol, on the studied anatomic unit.
-During the study: Do not use other cosmetic products than the tested product to the studied
areas (only the usual cleanser and make-up for the lips and eyes are accepted)
-During the study: Do not use hair oil
-The day of the measurements: No test product must be used (only face cleaned with water is accepted)
-For males, having not shaved their beard 24 hours prior to the day of measurement.
17.Refusing to follow the restrictions below during the study:
- Do not start, change or stop a hormonal treatment (hormonal contraception, cyproterone acetate…)
- Do not apply cosmetic products with anti-seborrheic aims or cosmetics for oily skin or for skin with imperfections
- Do not have beauty treatment (e.g. skin cleansing, exfoliation, scrub, mask …)
- Do not start a local or general treatment acting on seborrhoea
- Do not expose to the sun with the intention to sunbathe (activities outside which do not last too much time are authorized) 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Reduction in acne severity, Reduction in sebum, and Acne PIH spot.
 		 Baseline,15 minutes, 1 day,14 days & 28 days 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Not applicable 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "38"
Final Enrollment numbers achieved (India)="38" 
Phase of Trial   N/A 
Date of First Enrollment (India)   25/02/2023 
Date of Study Completion (India) 06/04/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

OBJECTIVE

To evaluate the in-vivo safety and efficacy of the skin care formulation in terms of reduction in acne severity, reduction in sebum and Acne PIH spot on healthy female & male subjects

Duration of study: 28 days study

Kinetics: T0, T+15 Minutes, T+1 day, T+14 days & T+28 days

Population: 40 volunteers(20 males and 20 females)

The evaluation is performed using:

- Subject Self Evaluation (SSE)

- Dermatological Evaluation: Cosmetic Acceptability

- Dermatological Evaluation: Efficacy

- Mexametry

- Sebumetry

- Illustrative photographs of whole face under diffused light

Product application : 

Cleanse face with face wash and pat dry. Take approximately 2-3 drops of the product .With gentle circular motion spread it all over the face. Apply the product twice a day in morning & at night on the whole face for the period of 28 days.

 
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