NCT03192592

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 2, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 13, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 20, 2017

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 26, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 28, 2017

Completed
Last Updated

June 28, 2017

Status Verified

June 1, 2017

Enrollment Period

2 months

First QC Date

June 13, 2017

Last Update Submit

June 27, 2017

Conditions

Skin Diseases, MetabolicSkin Care

Outcome Measures

Primary Outcomes (4)

  • Skin general appearance

    Standard guide for sensory claim substantiation - ASTM

    28 days

  • Skin texture

    Standard guide for sensory claim substantiation - ASTM

    28 days

  • Skin hydration

    Standard guide for sensory claim substantiation - ASTM

    28 days

  • Skin elasticity and visible cracking

    Standard guide for sensory claim substantiation - ASTM

    28 days

Secondary Outcomes (1)

  • Sensory evaluation of the product

    28 days

Study Arms (1)

Body moisturizer Apotech®

EXPERIMENTAL

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

Interventions

Body moisturizerOTHER

Daily body moisturizer application for skin protection and barrier.

Also known as: Apotech® SkinCare
Body moisturizer Apotech®

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Allergisa Pesquisa Dermato-Cosmetica

Campinas, São Paulo - Brazil, 13087-548, Brazil

Location

MeSH Terms

Conditions

Skin Diseases, Metabolic

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Lucas O. Guerra, MSc

    Allergisa Pesquisa Dermato-Cosmetica LTDA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: This study aim to verify the improvement of texture, elasticity and general appearance of the skin through the application of the cosmetic product Apotech®.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2017

First Posted

June 20, 2017

Study Start

May 2, 2017

Primary Completion

June 26, 2017

Study Completion

July 28, 2017

Last Updated

June 28, 2017

Record last verified: 2017-06

Locations

BR(1)