Safety and Effectiveness Evaluation of the Apotech® Diabetic Body Moisturizer

Not Applicable

• Conditions: Skin Care; Skin Diseases, Metabolic
• Interventions: Other: Body moisturizer

• Registration Number: NCT03192592
• Lead Sponsor: ANS Pharma

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 Timeline

• Study Start: 2017-05-02
• Status Verified: 2017-06
• Study First Submitted: 2017-06-13
• Study First Submitted QC: 2017-06-17
• Study First Posted: 2017-06-20
• Primary Completion: 2017-06-26
• Last Update Submitted: 2017-06-27
• Last Update Posted: 2017-06-28
• Study Completion: 2017-07-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 36

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Body moisturizer Apotech®	Body moisturizer	Instructions for use: Massage the product in the body twice a day (morning and evening) with gentle movements until completely absorption. Daily use for 28 days.

Primary Outcome Measures

Name	Time	Method
Skin texture	28 days	Standard guide for sensory claim substantiation - ASTM
Skin elasticity and visible cracking	28 days	Standard guide for sensory claim substantiation - ASTM
Skin general appearance	28 days	Standard guide for sensory claim substantiation - ASTM
Skin hydration	28 days	Standard guide for sensory claim substantiation - ASTM

Secondary Outcome Measures

Name	Time	Method
Sensory evaluation of the product	28 days	Standard questions

Trial Locations

Locations (1)

Allergisa Pesquisa Dermato-Cosmetica; 🇧🇷 Campinas, São Paulo - Brazil, Brazil