CeraVe Diabetes Mellitus

University of Miami

Status and phase: Completed; Phase 4

Conditions: Diabetes Complications

Treatments: Drug: CeraVe Hydrating Cleanser; Drug: CeraVe Moisturizing Cream

Study type: Interventional

Funder types: Other

Identifiers

NCT04724967

20201149

Details and patient eligibility

About

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.

Enrollment: 528 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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528 participants in 1 patient group

CeraVe Group

Experimental group

Description:

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

Treatment:

Drug: CeraVe Moisturizing Cream

Drug: CeraVe Hydrating Cleanser