Safety and Efficacy assessment of Product on skin

Not yet recruiting

Conditions: being able to produce at least 100 mg of sweat

Registration Number: CTRI/2022/06/043478

Lead Sponsor: Sun Pharmaceutical Industries Limited

Brief Summary: Objective: The objective of this study is to evaluate the in-vivo safety and efficacyof the skin care formulation in terms of sweat resistance on healthy humansubjects for test product

Kinetics: Day 1 (T0 &T+30 minutes after product application) and Day 2 (T0 & T+30 minutes afterproduct application)

Population: 33 (17 Female & 16 Male) subjects

Theevaluation is performed using:

- Subject Self Evaluation (SSE)

- Dermatological Evaluation: Cosmetic Acceptability

- Tewametry

- Sweat Patch Test

Duration: 2 days following the first application of theproduct.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 33

Inclusion Criteria

1.Indian male & 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.Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scarâ€¦.) 4.Being able to produce at least 100 mg of sweat and whose left versus right half face sweat is more or less the same 5.Having shaved beard two days before study visit.

Exclusion Criteria

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.Being insulin-dependent diabetic or non-insulin-dependent diabetic with a recent therapy (less than 6 months) 5.Having sensitive or dry skin & acne prone skin.
6.Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months) 7.Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products or food products.
8.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).
9.Having cutaneous hypersensitivity.
10.Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months.
11.Having changed her cosmetic habits in the 14 days preceding the start of the study on the studied anatomic unit.
12.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) 13.Refusing to follow the restrictions below during the study:For Females: 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 their cosmetic habits apart from the particular conditions mentioned in the protocol, on the studied anatomic unit; Do not have sensitive or dry skin & acne prone skin.; During the study: Do not use other cosmetic products than the tested products to the studied areas.; The day of the measurements: No test product must be used (only face cleaned with water is accepted); The day of the measurements: Do not apply hair oil.
14.Having started, changed or interrupted one hormonal treatment (hormonal contraception, Hormone Replacement Therapy) during the past 3 months 15.Having started, changed or stopped his/her tobacco consumption (for smokers consuming more than 10 cigarettes per day) in the previous 6 months 16.Not having shaved beard two days before study visit.
17.Having applied oil one day prior study visit.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
sweat resistance, safety	Day 1: 30 minutes after product application, Day 2: 30 minutes after product application

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (1): Mascot Spincontrol India Pvt. Ltd.
🇮🇳
Mumbai, MAHARASHTRA, India
Mascot Spincontrol India Pvt. Ltd.
🇮🇳Mumbai, MAHARASHTRA, India
Dr Raji Patil
Principal investigator
02243349191
raji@mascotspincontrol.in