CeraVe Diabetes Mellitus

Study Overview
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Brief Summary
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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.

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

Conditions
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Diabetes Complications

Intervention / Treatment
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* Drug: CeraVe Hydrating Cleanser
* Drug: CeraVe Moisturizing Cream


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CeraVe Group<br>Participants in this group will receive the CeraVe Hydrating Cleanser and Moisturizing Cream for 28 days. | Drug: CeraVe Hydrating Cleanser<br>* topical cleanser applied twice a day for 28 days<br>Drug: CeraVe Moisturizing Cream<br>* topical cream applied twice a day for 28 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Reporting Adverse Events (AE) | As evaluated by treating physician as possibly or probably related to intervention | 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. | 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). | At 33 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cutaneous complication of DM