To evaluate and compare the in-vivo safety and efficacy of Skin Care Formulation verses Untreated Control in terms of skin moisturization, skin brightness, skin softness, skin smoothness and skin barrier function on healthy female subjects
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 33
- Locations
- 1
- Primary Endpoint
- Skin moisturization, skin brightness, skin softness, skin smoothness and skin 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 Formulation verses Untreated Control in terms of skin moisturization, skin brightness, skin softness, skin smoothness and skin barrier function on healthy female subjects
The evaluation is performed using: Subject Self Evaluation, Dermatological Evaluation: Cosmetic Acceptability, Dermatological Evaluation: Efficacy, Corneometry, Tewametry, Chromametry
The study lasts 72 hours following the first application of the product on the forearm.
POPULATION- 33 Female subjects will be selected for the study.
The subjects selected for this study are healthy females, aged between 18 and 40 years old, having dry skin type.
STUDY DURATION- Duration: 72 hours following the first application of the product.
STUDY DESIGN - Single blind study, Comparative study, Subjects serve as their own reference for the intra-group comparison (evaluation of the efficacy on time of product) and do not serve as their own reference for the inter-group comparison (comparison of the efficacy of the test product A with Untreated Control).
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 brightness, skin softness, skin smoothness and skin barrier function
Time Frame: Baseline, 30 Minutes, 48 Hours, 72 Hours
Secondary Outcomes
No secondary outcomes reported
Investigators
Dr Pooja Yadav
MASCOT-SPINCONTROL India Pvt. Ltd.