Study to check the safety of cosmetic product on human volunteers

Not yet recruiting

Brief Summary: The objective of this study will be to evaluate the sensitization potential of Skin Care Formulation on healthy human subjects

The evaluation is performed using: Dermatological Evaluation: Human Repeat Insult Patch Test Method

Total duration of the study: 40 days following the first application of product.

Kinetics: Induction phase with 21 visits( T0, T1, T2, T3, T4, T5, T6, T7, T8, T9, T10, T11, T12, T13, T14, T15, T16, T17, T18, T19 and T20) then resting phase of 14 days and 5 days of Challenge phase( T21, T22, T23, T24 & T25)

The study is conducted in 3 phases: 1. Induction Phase, 2. Resting Phase,3. Challenge Plhase

Induction phase is of 21 days and in which 9 repeated applications of patches are carried out which are removed after 24 hours of application and evaluated after 24 hours of patch removal. Resting phase is of 14 days in which no application of any patch is done in order to develop sensitization to the test product. In Challenge phase only one patch is applied which is removed after 24 hours and evaluated after 24 hours 48 hours and 72 hours

Number of volunteers: 220 (110 male+110 female) subjects

Recruitment & Eligibility

Inclusion Criteria

Female and male Asian Indian subjects.
Healthy Human subjects 3.
Skin is healthy on the studied anatomic unit 4.
Having Photo type III to V 5.
Willingness to avoid intense UV exposure on test site, during the course of the study.
Willingness to avoid excessive water contact (for example swimming) or activity which causes excessive sweating, during the course of the study.

Exclusion Criteria

For female, Being pregnant or breastfeeding or having stopped to breastfeed in the past three months 2.
Having refused to give his or her assent by not signing the consent form 3.
Taking part in another study liable to interfere with this study 4.
Being diabetic.
Being asthmatic.
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).
Having cutaneous hypersensitivity (except in the case of studies with evaluation of sensitive skin).
Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products.
Having changed his or her cosmetic habits in the 14 days preceding the start of the study on the studied anatomic unit.

Primary Outcome Measures

Name	Time	Method
Sensitization potential	Day 3, Day 5, Day 7, Day 10, Day 12, Day 14, Day 17, Day 19, Day 21, Day 38, Day 39, Day 40

Secondary Outcome Measures

Name	Time	Method

Locations (1): Mascot Spincontrol India Pvt. Ltd.
🇮🇳
Mumbai, MAHARASHTRA, India
Mascot Spincontrol India Pvt. Ltd.
🇮🇳Mumbai, MAHARASHTRA, India
Dr Mohit Lalvani
Principal investigator
02243349191
mohit.CTRI@gmail.com