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 minor girls & boys subjects
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 66
- Locations
- 1
- Primary Endpoint
- 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 minor girls & boys subjects. The evaluation will be performed using:Subject Self Evaluation (SSE), Dermatological Evaluation: Cosmetic Acceptability, Dermatological Evaluation : Efficacy, Corneometry, Tewametry
POPULATION : 66 minor girls & boys subjects will be selected for the study. The study will be conducted in 2 groups 33 (16 boys & 17 girls / 17 boys & 16 girls) subjects in each group.Group A: - Product A & Product B
Group B: - Product C & Product D
The subjects selected for this study will be healthy minor aged between 12 and 17 years, having dry skin type.
STUDY DURATION : 48 hours following the application of the product.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 12.00 Year(s) to 17.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Indian girl & boys subjects.
- •Healthy subjects 3)Skin is healthy on the studied anatomic unit.
- •Subject having dry skin type.
Exclusion Criteria
- •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
Moisturization & skin water barrier function
Time Frame: Baseline, 30 minutes, 24 Hours and 48 Hours after product application
Secondary Outcomes
No secondary outcomes reported
Investigators
Dr Pooja Yadav
MASCOT-SPINCONTROL India Pvt. Ltd.