CeraVe Diabetes Mellitus

University of Miami528 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

528

Conditions

Diabetes Complications

Interventions

CeraVe Hydrating CleanserDRUG

topical cleanser applied twice a day for 28 days

CeraVe Moisturizing CreamDRUG

topical cream applied twice a day for 28 days

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

University of Miami

Miami, Florida, United States

Outcomes

Primary Outcomes

Percentage of Participants Reporting Adverse Events (AE)

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

Time frame: Up to 33 days

Number of Participants at Each GAIS Grading Scale

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.

Time frame: At 33 days

Number of Participants at Each Dry Skin Scale

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).

Time frame: At 33 days

Data from ClinicalTrials.gov

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