Clinical trial to check the safety and effectiveness of product on human volunteers

Not yet recruiting

Brief Summary: OBJECTIVE - The objective of this study will be to evaluatethe in-vivo efficacy and safety of a skin care formulation in terms ofanti-aging parameter i.e. reduction in fine lines and wrinkles, improvement inskin firmness, skin elasticity and skin tone on healthy female subjects forproduct coded:

The evaluation is performed using: Subject Self Evaluation, DermatologicalEvaluation: Cosmetic Acceptability, Dermatological Evaluation: Efficacy, Antera3D, Cutometry, Chromametry, Digital Photography

POPULATION- 36 Female subjects will be selected for thestudy.

The subjects selected for this study are healthy females,aged between 34 and 60 years old with average mean age 46, having mild tomoderate dark circles and wrinkles.

STUDY DURATION- 28 days following the first application ofthe product.

Recruitment & Eligibility

Inclusion Criteria

1)Healthy subjects 2)Skin is healthy on the studied anatomic unit 3)Having mild to moderate dark circles and wrinkles.

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
Antiaging parameter i.e. reduction in fine lines and wrinkles, improvement in skin firmness, skin elasticity and skin tone	Baseline, Day 5 and Day 28

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