CeraVe Diabetes Mellitus

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 10, 2021

Interventions

  • Drug: CeraVe Hydrating Cleanser
    • topical cleanser applied twice a day for 28 days
  • Drug: CeraVe Moisturizing Cream
    • topical cream applied twice a day for 28 days

Arms, Groups and Cohorts

  • Experimental: CeraVe Group
    • Participants in this group will receive the CeraVe Hydrating Cleanser and Moisturizing Cream for 28 days.

Clinical Trial Outcome Measures

Primary Measures

  • 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
  • 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.
  • 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).

Participating in This Clinical Trial

Inclusion Criteria

1. Men or women between the ages of 18 and 75 years of age. 2. Willing to provide written informed consent. 3. A diagnosis of diabetes mellitus (DM). 4. 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:

1. History of allergy, anaphylaxis or hypersensitivity to any of the ingredients in CeraVe Hydrating Cleanser or Moisturizing Cream 2. History of allergic contact dermatitis secondary to cleansers or moisturizers. 3. Has a heightened immune response to common allergens, especially inhaled, topical or food allergens (atopy). 4. 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. 5. Inability to attend all study visits and follow treatment regimen.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Miami
  • Collaborator
    • CeraVe
  • Provider of Information About this Clinical Study
    • Principal Investigator: Robert S. Kirsner, Professor – University of Miami
  • Overall Official(s)
    • Robert Kirsner, MD/PhD, Principal Investigator, University of Miami

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