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Safety and Effectiveness Evaluation of the Apotech® Diabetic Body Moisturizer (Apotech)

Primary Purpose

Skin Diseases, Metabolic, Skin Care

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Body moisturizer
Sponsored by
ANS Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Skin Diseases, Metabolic

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects with controlled diabetes
  • Any phototype and all skin types

Exclusion Criteria:

  • Pregnant women
  • Subjects that not match the inclusion criteria

Sites / Locations

  • Allergisa Pesquisa Dermato-Cosmetica

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Body moisturizer Apotech®

Arm Description

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.

Outcomes

Primary Outcome Measures

Skin general appearance
Standard guide for sensory claim substantiation - ASTM
Skin texture
Standard guide for sensory claim substantiation - ASTM
Skin hydration
Standard guide for sensory claim substantiation - ASTM
Skin elasticity and visible cracking
Standard guide for sensory claim substantiation - ASTM

Secondary Outcome Measures

Sensory evaluation of the product
Standard questions

Full Information

First Posted
June 13, 2017
Last Updated
June 27, 2017
Sponsor
ANS Pharma
Collaborators
Allergisa Pesquisa Dermato-Cosmetica LTDA
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1. Study Identification

Unique Protocol Identification Number
NCT03192592
Brief Title
Safety and Effectiveness Evaluation of the Apotech® Diabetic Body Moisturizer
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
May 2, 2017 (Actual)
Primary Completion Date
June 26, 2017 (Actual)
Study Completion Date
July 28, 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ANS Pharma
Collaborators
Allergisa Pesquisa Dermato-Cosmetica LTDA

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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®.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Diseases, Metabolic, Skin Care

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This study aim to verify the improvement of texture, elasticity and general appearance of the skin through the application of the cosmetic product Apotech®.
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Body moisturizer Apotech®
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Body moisturizer
Other Intervention Name(s)
Apotech® SkinCare
Intervention Description
Daily body moisturizer application for skin protection and barrier.
Primary Outcome Measure Information:
Title
Skin general appearance
Description
Standard guide for sensory claim substantiation - ASTM
Time Frame
28 days
Title
Skin texture
Description
Standard guide for sensory claim substantiation - ASTM
Time Frame
28 days
Title
Skin hydration
Description
Standard guide for sensory claim substantiation - ASTM
Time Frame
28 days
Title
Skin elasticity and visible cracking
Description
Standard guide for sensory claim substantiation - ASTM
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Sensory evaluation of the product
Description
Standard questions
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects with controlled diabetes Any phototype and all skin types Exclusion Criteria: Pregnant women Subjects that not match the inclusion criteria
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lucas O. Guerra, MSc
Organizational Affiliation
Allergisa Pesquisa Dermato-Cosmetica LTDA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Allergisa Pesquisa Dermato-Cosmetica
City
Campinas
State/Province
São Paulo - Brazil
ZIP/Postal Code
13087-548
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Safety and Effectiveness Evaluation of the Apotech® Diabetic Body Moisturizer

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