To evaluate and compare the invivo safety and efficacy of Skin Care Formulation verses Untreated Control in terms of skin moisturization and skin barrier function on healthy human subjects
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- G.D. Pharmaceuticals Pvt. Ltd.
- Enrollment
- 33
- Locations
- 1
- Primary Endpoint
- Skin moisturization and skin barrier function
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 and skin barrier function on healthy human subjects.
The evaluation is performed using: Subject Self Evaluation, Dermatological Evaluation: Cosmetic Acceptability, Dermatological Evaluation:Efficacy, Corneometry, Tewametry.
The study lasts 2 days following the first application of the product on the forearm.
POPULATION- 33(16/17 males & 16/17 Female) subjects will be selected for the study .
The subjects selected for this study are healthy male & female, aged between 18 and 40 years old, having dry skin type.
STUDY DURATION-Duration: 24 hours following the first 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
- All
Inclusion Criteria
- •Indian 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.
Outcomes
Primary Outcomes
Skin moisturization and skin barrier function
Time Frame: Baseline, 30 Minutes, 24 Hours
Secondary Outcomes
No secondary outcomes reported
Investigators
Dr Pooja Yadav
MASCOT-SPINCONTROL India Pvt. Ltd.