To evaluate the safety and efficacy of skin care formulation in terms of skin hydration, skin water barrier, glow, firmness, elasticity, brightness and dark spots on healthy male and female subjects.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- skin hydration, skin water barrier, glow, firmness/elasticity, brightness, dark spots
Study Overview
Brief Summary
OBJECTIVE· Primary Objective
The objective of this study is to evaluate the safety and efficacy of skin care formulation in terms of skin hydration, skin water barrier, glow, firmness/elasticity, brightness, acne PIH spots, on healthy male and female subjects.
· Secondary Objective
Secondary objective is to evaluate the in-vivo efficacy of a skin care formulation in terms of skin softness & smoothness, dark spot density, brightness, wrinkles, fine lines on healthy male and female subjects.
The evaluation will be performed using: Subject Self Evaluation (SSE), Dermatological Evaluation: Cosmetic Acceptability, Dermatological Evaluation: Efficacy, Chromametry, Tewametry, Corneometry, Glossymetry, Mexametry, Cutometry, Dino-lite, Antera 3D, Digital Photographs
POPULATION36 (18 males & 18 females) will be selected for the study.
The subjects selected for this study will be healthy male & females, aged between 25 and 50 years, having dull skin with visible wrinkles, fine lines, and dark spots.
STUDY DURATIONDuration: 28 days following the first application of the product.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- Participant and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 25.00 Year(s) to 50.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Indian male & female subjects 2.Healthy subjects 3.Skin is healthy on the studied anatomic unit 4.Having dull skin with visible wrinkles, fine lines, dark spot.
Exclusion Criteria
- •1 For female:- Being pregnant or breastfeeding or having stopped to breastfeed in the past three months 2 Having refused to give 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 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.
- •9 Following a chronic medicinal treatment comprising any of the following products: aspirin-based products, anti-inflammatories, antihistamines, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol) 10 Having cutaneous hypersensitivity.
- •11 Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products.
- •12 Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months.
Outcomes
Primary Outcomes
skin hydration, skin water barrier, glow, firmness/elasticity, brightness, dark spots
Time Frame: Baseline, 30 minutes after application, 8 hours after application, Day 1, day 7, Day 14, Day 28
Secondary Outcomes
- skin softness & smoothness, dark spot density, brightness, wrinkles, fine lines(baseline, 30 minutes after application, 8 hours after application, Day 1, day 7, Day 14, Day 28)
Investigators
Dr Niharika Salian
MASCOT-SPINCONTROL India Pvt. Ltd.