The Study to assess safety and effectiveness of product on human volunteers

Not yet recruiting

Brief Summary: OBJECTIVE:The objective of this study is to evaluate the in-vivo safety and efficacy ofskin care formulation in terms of improvement in skin brightness on healthyhuman subjects

Theevaluation is performed using: Subject Self Evaluation (SSE), DermatologicalEvaluation: Cosmetic Acceptability, Chromametry

POPULATION:36 (18 male and 18 female) subjects will be selected for the study.

Thesubjects selected for this study will be healthy females & male, agedbetween 18 and 45 years, having wheatish to dark complexion.

STUDYDURATION: Duration: 28 days following the first application of the product.

STUDYDESIGN : Single blind study, Non-Comparative study, Subjects will serve astheir own references.

Recruitment & Eligibility

Inclusion Criteria

1)Indian male and female subjects.
2)Healthy subjects 3)Skin is healthy on the studied anatomic unit 4)Having wheatish to dark complexion.

Exclusion Criteria

Being pregnant or breastfeeding or having stopped to breastfeed in the past three months.
Having refused to give his/her assent by not signing the consent form and Informed consent form 3.
Taking part in another study liable to interfere with this study 4.
Being known diabetic case 5.
Known asthma case 6.
Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area (except for specific studies on a determined dermatosis) 7.
Being known thyroid case 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 or corticosteroid by any route (the only medication permitted is paracetamol) 10.
Known case of hypersensitivity.
Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products.
Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months.

Primary Outcome Measures

Name	Time	Method
Improvement in skin brightness	Baseline, Day 7, Day 14 and Day28

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