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NCT03192592 Clinical Trial

Safety and Effectiveness Evaluation of the Apotech® Diabetic Body Moisturizer

Skin Care Clinical Trial

— Apotech  

Official title:
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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03192592
Other study ID # 060935_01
Secondary ID
Status Active, not recruiting
Phase N/A
First received June 13, 2017
Last updated June 27, 2017
Start date May 2, 2017
Est. completion date July 28, 2017

Study information
Verified date June 2017
Source ANS Pharma
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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®.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 36
Est. completion date July 28, 2017
Est. primary completion date June 26, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- Subjects with controlled diabetes

- Any phototype and all skin types

Exclusion Criteria:

- Pregnant women

- Subjects that not match the inclusion criteria

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Body moisturizer
Daily body moisturizer application for skin protection and barrier.

Locations
Country Name City State
Brazil Allergisa Pesquisa Dermato-Cosmetica Campinas São Paulo - Brazil

Sponsors (2)
Lead Sponsor Collaborator
ANS Pharma Allergisa Pesquisa Dermato-Cosmetica LTDA

Country where clinical trial is conducted

Brazil, 

Outcome
Type Measure Description Time frame Safety issue
Primary Skin general appearance Standard guide for sensory claim substantiation - ASTM 28 days
Primary Skin texture Standard guide for sensory claim substantiation - ASTM 28 days
Primary Skin hydration Standard guide for sensory claim substantiation - ASTM 28 days
Primary Skin elasticity and visible cracking Standard guide for sensory claim substantiation - ASTM 28 days
Secondary Sensory evaluation of the product Standard questions 28 days
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