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CeraVe Diabetes Mellitus

Sponsor
University of Miami (Other)
Overall Status
Completed
CT.gov ID
NCT04724967
Collaborator
CeraVe (Other)
16
Enrollment
1
Location
1
Arm
5
Actual Duration (Months)
3.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: CeraVe Hydrating Cleanser
  • Drug: CeraVe Moisturizing Cream
 Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
16 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Mar 12, 2021
Actual Primary Completion Date :
Aug 10, 2021
Actual Study Completion Date :
Aug 10, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: CeraVe Group

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

Drug: CeraVe Hydrating Cleanser
topical cleanser applied twice a day for 28 days

Drug: CeraVe Moisturizing Cream
topical cream applied twice a day for 28 days

Outcome Measures

Primary Outcome Measures

  1. Percentage of participants reporting adverse events (AE) [Up to 33 days]

    As evaluated by treating physician

  2. Frequency of participants reporting adverse events (AE) [Up to 33 days]

    As evaluated by treating physician

  3. Physician-assessed Global Aesthetic Improvement Scale (GAIS) [up to 33 days]

    GAIS is rated from 3 (very much improved) to minus 3 (very much worse)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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:

  1. 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Miami Miami Florida United States 33136

Sponsors and Collaborators

  • University of Miami
  • CeraVe

Investigators

  • Principal Investigator: Robert Kirsner, MD/PhD, University of Miami

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Robert S. Kirsner, Professor, University of Miami
ClinicalTrials.gov Identifier:
NCT04724967
Other Study ID Numbers:
  • 20201149
First Posted:
Jan 26, 2021
Last Update Posted:
Dec 3, 2021
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Keywords provided by Robert S. Kirsner, Professor, University of Miami
cutaneous complication of DM
Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Complications
Dimenhydrinate

Study Results

No Results Posted as of Dec 3, 2021