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CeraVe Diabetes Mellitus

Primary Purpose

Diabetes Complications

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
CeraVe Hydrating Cleanser
CeraVe Moisturizing Cream
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Complications focused on measuring cutaneous complication of DM

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • University of Miami

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CeraVe Group

Arm Description

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

Outcomes

Primary Outcome Measures

Percentage of Participants Reporting Adverse Events (AE)
As evaluated by treating physician as possibly or probably related to intervention
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.
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).

Secondary Outcome Measures

Full Information

First Posted
January 21, 2021
Last Updated
August 29, 2022
Sponsor
University of Miami
Collaborators
CeraVe
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1. Study Identification

Unique Protocol Identification Number
NCT04724967
Brief Title
CeraVe Diabetes Mellitus
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
March 12, 2021 (Actual)
Primary Completion Date
August 10, 2021 (Actual)
Study Completion Date
August 10, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
CeraVe

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Complications
Keywords
cutaneous complication of DM

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
528 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CeraVe Group
Arm Type
Experimental
Arm Description
Participants in this group will receive the CeraVe Hydrating Cleanser and Moisturizing Cream for 28 days.
Intervention Type
Drug
Intervention Name(s)
CeraVe Hydrating Cleanser
Intervention Description
topical cleanser applied twice a day for 28 days
Intervention Type
Drug
Intervention Name(s)
CeraVe Moisturizing Cream
Intervention Description
topical cream applied twice a day for 28 days
Primary Outcome Measure Information:
Title
Percentage of Participants Reporting Adverse Events (AE)
Description
As evaluated by treating physician as possibly or probably related to intervention
Time Frame
Up to 33 days
Title
Number of Participants at Each GAIS Grading Scale
Description
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.
Time Frame
At 33 days
Title
Number of Participants at Each Dry Skin Scale
Description
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).
Time Frame
At 33 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Kirsner, MD/PhD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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CeraVe Diabetes Mellitus

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