CeraVe Diabetes Mellitus

Phase 4

Completed

• Conditions: Diabetes Complications
• Interventions: Drug: CeraVe Hydrating Cleanser; Drug: CeraVe Moisturizing Cream

• Registration Number: NCT04724967
• Lead Sponsor: University of Miami

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-21
• Study First Submitted QC: 2021-01-21
• Study First Posted: 2021-01-26
• Study Start: 2021-03-12
• Primary Completion: 2021-08-10
• Study Completion: 2021-08-10
• Results First Submitted: 2022-07-15
• Status Verified: 2022-08
• Results First Submitted QC: 2022-08-29
• Last Update Submitted: 2022-08-29
• Results First Posted: 2022-09-22
• Last Update Posted: 2022-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 528

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Reporting Adverse Events (AE)	Up to 33 days	As evaluated by treating physician as possibly or probably related to intervention
Number of Participants at Each Dry Skin Scale	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).
Number of Participants at Each GAIS Grading Scale	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.

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States