Phase 4
N=528
CeraVe Diabetes Mellitus
Diabetes Complications
Bottom Line
View on ClinicalTrials.gov: NCT04724967 ↗Enrolled (actual)
528
Serious AEs
0.0%
Results posted
Sep 2022
Primary outcome: Primary: Percentage of Participants Reporting Adverse Events (AE) — 0 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- CeraVe Hydrating Cleanser (Drug); CeraVe Moisturizing Cream (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Miami
- Primary completion
- Aug 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Reporting Adverse Events (AE) |
— | — |
| PRIMARY Number of Participants at Each GAIS Grading Scale |
223; 224; 72; 9; 0 | — |
| PRIMARY Number of Participants at Each Dry Skin Scale |
271; 219; 28; 7; 3; 386 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT04724967). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.