CeraVe Diabetes Mellitus

Diabetes Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04724967
• Other study ID #: 20201149
• Status: Completed
• Phase: Phase 4
• Start date: March 12, 2021
• Est. completion date: August 10, 2021

Study information

• Verified date: August 2022
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 528
• Est. completion date: August 10, 2021
• Est. primary completion date: August 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Complications
• Diabetes Mellitus

Intervention

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

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	CeraVe

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Reporting Adverse Events (AE)	As evaluated by treating physician as possibly or probably related to intervention	Up to 33 days
Primary	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
Primary	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