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Safety and Effectiveness Evaluation of the Apotech® Diabetic Body Moisturizer

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03192592
Acronym
Apotech
Enrollment
36
Registered
2017-06-20
Start date
2017-05-02
Completion date
2017-07-28
Last updated
2017-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Skin Care, Skin Diseases, Metabolic

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®.

Interventions

OTHERBody moisturizer

Daily body moisturizer application for skin protection and barrier.

Sponsors

Allergisa Pesquisa Dermato-Cosmetica LTDA
CollaboratorINDUSTRY
ANS Pharma
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

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®.

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Pregnant women * Subjects that not match the inclusion criteria

Design outcomes

Primary

MeasureTime frameDescription
Skin general appearance28 daysStandard guide for sensory claim substantiation - ASTM
Skin texture28 daysStandard guide for sensory claim substantiation - ASTM
Skin hydration28 daysStandard guide for sensory claim substantiation - ASTM
Skin elasticity and visible cracking28 daysStandard guide for sensory claim substantiation - ASTM

Secondary

MeasureTime frameDescription
Sensory evaluation of the product28 daysStandard questions

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026