CeraVe Diabetes Mellitus

NCT04724967 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 20201149
• Study Type: interventional
• Target: 528
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Complications

Keywords

cutaneous complication of DM

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

CeraVe Group

EXPERIMENTAL

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

Drug: CeraVe Hydrating Cleanser; Drug: CeraVe Moisturizing Cream

Interventions

CeraVe Hydrating Cleanser DRUG

topical cleanser applied twice a day for 28 days

CeraVe Group

CeraVe Moisturizing Cream DRUG

topical cream applied twice a day for 28 days

CeraVe Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Miami: lead
• CeraVe: collaborator

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Diabetes Complications

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Endocrine System Diseases

Results Point of Contact

• Title: Robert Kirsner
• Organization: University of Miami

rkirsner@med.miami.edu

305-689-2646

Study Officials

• Robert Kirsner, MD/PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 21, 2021
• First Posted: January 26, 2021
• Study Start: March 12, 2021
• Primary Completion: August 10, 2021
• Study Completion: August 10, 2021
• Last Updated: September 22, 2022
• Results First Posted: September 22, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)