To evaluate and compare the invivo safety and efficacy of Skin Care Formulations versus Untreated control in terms of the moisturization & skin water barrier function on healthy female subjects
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 66
- Locations
- 1
- Primary Endpoint
- Skin moisturization & skin water barrier function
Study Overview
Brief Summary
OBJECTIVE
The objective of this study will be to evaluate and compare the in-vivo safety and efficacy of Skin Care Formulations versus Untreated control in terms of the moisturization & skin water barrier function on healthy female subjects.
The evaluation will be performed using:Subject Self Evaluation (SSE), Dermatological Evaluation: Cosmetic Acceptability, Corneometry, Tewametry
The study will last 24 hours, following the application of the product.
POPULATION
66 females subjects will be selected for the study. The study will be conducted in 2 groups 33 females subjects in each group.
Group A :- Product A & Product C
Group B :- Product B & Product D
The subjects selected for this study will be healthy females aged between 18 and 40 years, having dry skin type.
STUDY DURATION
Duration: 24 hours following the application of the product.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 40.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •Indian female subjects 2)Healthy subjects 3)Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar) 4)Subject having dry skin type.
Exclusion Criteria
- •Being pregnant or breastfeeding or having stopped to breastfeed in the past three months
- •Having refused to give her/his assent by not signing the consent form
- •Taking part in another study liable to interfere with this study
- •Being insulin-dependent diabetic or non-insulin-dependent diabetic with a recent therapy (less than 6 months)
- •Having a progressive asthma (either under treatment or last fit in the last 2 years)
- •Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area (except for specific studies on a determined dermatosis)
- •Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months)
- •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)
- •Having cutaneous hypersensitivity.
- •Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products.
Outcomes
Primary Outcomes
Skin moisturization & skin water barrier function
Time Frame: Baseline, 30 Minutes, 8 Hours, 24Hours
Secondary Outcomes
No secondary outcomes reported
Investigators
Dr Pooja Yadav
MASCOT-SPINCONTROL India Pvt. Ltd.