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 female subjects
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Alembic Pharmaceuticals 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 female subjects for product.
Test Product: Oryza Acne Cream: Product A
Techniques: The evaluation is performed using: 1) Subject Self Evaluation, 2) Dermatological Evaluation: Safety, 3) Corneometry and 4) Tewametry
Total duration of the study: 72 hours following the first application of the product.
Kinetics: T0, T+30 Minutes, T+24 hours, T+48 hours & T+72 Hours after product application
POPULATION: 33 female subjects will be selected for the study.
The subjects selected for this study are healthy female subject, aged between 18 and 40 years old, having dry skin on forearms
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
- •1.Indian female subjects 2.Healthy subjects 3.Skin is healthy on the studied anatomic unit 4.Subject having dry skin on forearms.
Exclusion Criteria
- •Being pregnant or breastfeeding or having stopped to breastfeed in the past three months.
- •Having refused to give his/her assent by not signing the consent form and Informed consent form
- •Taking part in another study liable to interfere with this study
- •Being known diabetic case
- •Known asthma case
- •Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area (except for specific studies on a determined dermatosis)
- •Being known thyroid case
- •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 or corticosteroid by any route (the only medication permitted is paracetamol)
- •Known case of hypersensitivity.
Outcomes
Primary Outcomes
skin moisturization and skin barrier function
Time Frame: T0, 30 Minutes, 24 hours, 48 hours & 72 Hours after product application
Secondary Outcomes
No secondary outcomes reported
Investigators
Dr Pooja Yadav
MASCOT-SPINCONTROL India Pvt. Ltd.