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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03192592
Recruitment Status : Unknown
Verified June 2017 by ANS Pharma.
Recruitment status was:  Active, not recruiting
First Posted : June 20, 2017
Last Update Posted : June 28, 2017
Sponsor:
Collaborator:
Allergisa Pesquisa Dermato-Cosmetica LTDA
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Skin Diseases, Metabolic Skin Care Other: Body moisturizer Not Applicable

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®.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Prevention
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
Actual Study Start Date : May 2, 2017
Actual Primary Completion Date : June 26, 2017
Estimated Study Completion Date : July 28, 2017

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 Name: Apotech® SkinCare




Primary Outcome Measures :
  1. Skin general appearance [ Time Frame: 28 days ]
    Standard guide for sensory claim substantiation - ASTM

  2. Skin texture [ Time Frame: 28 days ]
    Standard guide for sensory claim substantiation - ASTM

  3. Skin hydration [ Time Frame: 28 days ]
    Standard guide for sensory claim substantiation - ASTM

  4. Skin elasticity and visible cracking [ Time Frame: 28 days ]
    Standard guide for sensory claim substantiation - ASTM


Secondary Outcome Measures :
  1. Sensory evaluation of the product [ Time Frame: 28 days ]
    Standard questions



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnant women
  • Subjects that not match the inclusion criteria

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03192592


Locations
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Brazil
Allergisa Pesquisa Dermato-Cosmetica
Campinas, São Paulo - Brazil, Brazil, 13087-548
Sponsors and Collaborators
ANS Pharma
Allergisa Pesquisa Dermato-Cosmetica LTDA
Investigators
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Principal Investigator: Lucas O. Guerra, MSc Allergisa Pesquisa Dermato-Cosmetica LTDA

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Responsible Party: ANS Pharma
ClinicalTrials.gov Identifier: NCT03192592     History of Changes
Other Study ID Numbers: 060935_01
First Posted: June 20, 2017    Key Record Dates
Last Update Posted: June 28, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Skin Diseases
Metabolic Diseases
Skin Diseases, Metabolic