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Completed

NCT Number: NCT04724967

CeraVe Diabetes Mellitus

The purpose of this study is to evaluate the safety and efficacy of the CeraVe Diabetic Skin Line for the improvement of skin condition in patients with diabetes mellitus.

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Key information

Conditions

Diabetes Complications Diabetes Mellitus Endocrine System Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Miami

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men or women between the ages of 18 and 75 years of age.
  • Willing to provide written informed consent.
  • A diagnosis of diabetes mellitus (DM).
  • DM-related skin changes classified into one or more of the following four categories: i) skin lesions associated with DM; ii) infections; iii) cutaneous manifestations of DM complications; iv) skin reaction to DM treatment.

Exclusion criteria

  • History of allergy, anaphylaxis or hypersensitivity to any of the ingredients in CeraVe Hydrating Cleanser or Moisturizing Cream
  • History of allergic contact dermatitis secondary to cleansers or moisturizers.
  • Has a heightened immune response to common allergens, especially inhaled, topical or food allergens (atopy).
  • Has any clinical manifestation in the treatment are(s) or other disorders that, in the investigator's opinion, may affect assessments or the study products.
  • Inability to attend all study visits and follow treatment regimen.

Treatment and study plan

CeraVe Hydrating Cleanser

Drug

topical cleanser applied twice a day for 28 days

CeraVe Moisturizing Cream

Drug

topical cream applied twice a day for 28 days

Primary outcomes

  1. Percentage of Participants Reporting Adverse Events (AE)

    Time frame: Up to 33 days

    As evaluated by treating physician as possibly or probably related to intervention

  2. Number of Participants at Each GAIS Grading Scale

    Time frame: At 33 days

    Physician-assessed number of participants at each Global Aesthetic Improvement Scale (GAIS). GAIS has gradings of very much improved, much improved, improved, no change and worse. A grading of worse means the least aesthetic improvement.

  3. Number of Participants at Each Dry Skin Scale

    Time frame: At 33 days

    Physician-assessed number of participants at each Dry Skin Scale. Scales will be evaluated for each of the following conditions: roughness/scaling, itch, pain, erythema and fissures. Each condition will be scored from 0 (none), 1 (almost none), 2 (mild), 3 (moderate) to 4 (severe).

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • CeraVe

Registry information

Official study title

Clinical Evaluation of CeraVe Hydrating Cleanser and Moisturizing Cream for the Improvement of Skin Condition in Patients With Diabetes Mellitus (DM) Related Skin Changes

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 26, 2021
Registry last updated
Sep 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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