Safety and Effectiveness Evaluation of a New Moisturizer Formulation With Antioxidant, Anti-inflammatory and Anti-microbial Effects in the Prevention of a Diabetic Skin Dryness and Complications
Overview
- Phase
- Not Applicable
- Sponsor
- ANS Pharma
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Skin texture
Overview
Brief Summary
Safety and effectiveness evaluation of a new moisturizer formulation with antioxidant, anti-inflammatory and anti-microbial effects in the prevention of diabetics dry skin and complications.
Detailed Description
Safety and effectiveness evaluation of a new moisturizer formulation with antioxidant, anti-inflammatory and anti-microbial effects in the prevention of diabetics dry skin and complications. This study aim to address the target population, subjects with controlled diabetes, to verify the improvement of texture, elasticity, and general appearance of the skin through the application of the cosmetic product Apotech®.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subjects with controlled diabetes
- •Any phototype and all skin types
Exclusion Criteria
- •Pregnant women
- •Subjects that not match the inclusion criteria
Outcomes
Primary Outcomes
Skin texture
Time Frame: 28 days
Standard guide for sensory claim substantiation - ASTM
Skin elasticity and visible cracking
Time Frame: 28 days
Standard guide for sensory claim substantiation - ASTM
Skin general appearance
Time Frame: 28 days
Standard guide for sensory claim substantiation - ASTM
Skin hydration
Time Frame: 28 days
Standard guide for sensory claim substantiation - ASTM
Secondary Outcomes
- Sensory evaluation of the product(28 days)