The study to check the safety and effectiveness of cosmetic product

Not yet recruiting

Brief Summary: OBJECTIVE: The objectiveof this study is to evaluate and compare the in-vivo safety & efficacy ofSkin care formulation in terms of 48 hours odour suppression, skin brightnessand skin hydration on healthy human subjects.

The evaluation isperformed using: Subject Self Evaluation (SSE), Dermatological Evaluation:Safety, Expert Evalution for Efficacy by Axillary Odour Test, Corneometry, Chromametry

POPULATION: 36 (18 maleand 18 female) healthy subjects are selected for the study.

The subjects selectedfor this study are healthy human subjects, aged between 18 and 50 years, havingmild to moderate body odour & having a habit of using deodorant.

All 36 subjects will useProduct A on randomized underarm & another underarm will be considered asuntreated control.

STUDY DURATION: 48 hoursfollowing the first application of the product.

Recruitment & Eligibility

Inclusion Criteria

1)Indian subjects 2)Healthy subjects 3)Skin is healthy on the studied anatomic unit 4)Having mild to moderate body odour.
5)Having a habit of using deodorant.

Exclusion Criteria

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.
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.
Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products.

Primary Outcome Measures

Name	Time	Method
48 hours odour suppression, skin brightness and skin hydration	Baseline, 30 minutes, 24 hours and 48 hours after product application

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 Pooja Yadav
Principal investigator
02243349191
poojayadav@mascotspincontrol.in