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

June 27, 2017 updated by: ANS Pharma

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • São Paulo - Brazil
      • Campinas, São Paulo - Brazil, Brazil, 13087-548
        • Allergisa Pesquisa Dermato-Cosmetica

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnant women
  • Subjects that not match the inclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Body moisturizer Apotech®
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.
Other: Body moisturizer
Daily body moisturizer application for skin protection and barrier.
Other Names:
  • Apotech® SkinCare

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Skin general appearance
Time Frame: 28 days
Standard guide for sensory claim substantiation - ASTM
28 days
Skin texture
Time Frame: 28 days
Standard guide for sensory claim substantiation - ASTM
28 days
Skin hydration
Time Frame: 28 days
Standard guide for sensory claim substantiation - ASTM
28 days
Skin elasticity and visible cracking
Time Frame: 28 days
Standard guide for sensory claim substantiation - ASTM
28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensory evaluation of the product
Time Frame: 28 days
Standard questions
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ANS Pharma

Collaborators

Allergisa Pesquisa Dermato-Cosmetica LTDA

Investigators

  • Principal Investigator: Lucas O. Guerra, MSc, Allergisa Pesquisa Dermato-Cosmetica Ltda

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 2, 2017

Primary Completion (ACTUAL)

June 26, 2017

Study Completion (ANTICIPATED)

July 28, 2017

Study Registration Dates

First Submitted

June 13, 2017

First Submitted That Met QC Criteria

June 17, 2017

First Posted (ACTUAL)

June 20, 2017

Study Record Updates

Last Update Posted (ACTUAL)

June 28, 2017

Last Update Submitted That Met QC Criteria

June 27, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 060935_01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Skin Care

Clinical Trials on Body moisturizer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kenya

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe