Diabetes ComplicationsPhase 4NCT04724967
CeraVe Diabetes Mellitus
A Phase 4 study testing CeraVe Hydrating Cleanser and CeraVe Moisturizing Cream in people with Diabetes Complications, run by University of Miami at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Complications
- What is being tested?
- CeraVe Hydrating Cleanser and CeraVe Moisturizing Cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 528 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Mar 2021to 10 Aug 2021
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- CeraVe Hydrating Cleanser, CeraVe Moisturizing Cream
- Keywords
- cutaneous complication of DM
- Medical subject headings
- Diabetes Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CeraVe Hydrating CleanserDrug
topical cleanser applied twice a day for 28 days
CeraVe Moisturizing CreamDrug
topical cream applied twice a day for 28 days
| Study group | Role | What they receive |
|---|---|---|
| CeraVe Group | Experimental | Participants in this group will receive the CeraVe Hydrating Cleanser and Moisturizing Cream for 28 days. Receives: Drug: CeraVe Hydrating Cleanser; Drug: CeraVe Moisturizing Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Reporting Adverse Events (AE)
As evaluated by treating physician as possibly or probably related to intervention
Measured: 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.
Measured: 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).
Measured: At 33 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2021
- Study start12 Mar 2021
- Primary completion10 Aug 2021
- Study completion10 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetes ComplicationsStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 528 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- CeraVe
- Responsible party
- Principal investigator, Robert S. Kirsner, University of Miami
- Investigators
- Robert Kirsner, MD/PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04724967
- Sponsor's protocol ID
- 20201149
- Status last verified
- Aug 2022
- First submitted
- 21 Jan 2021
- Last updated
- 22 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04724967
- Acronym / sponsor ID
- 20201149
- Conditions
- Diabetes Complications
- Keywords
- cutaneous complication of DM
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 528 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- CeraVe
- Study start
- 12 Mar 2021 (actual)
- Primary completion
- 10 Aug 2021 (actual)
- Study completion
- 10 Aug 2021 (actual)
- First posted
- 26 Jan 2021 (actual)
- Results
- Posted 22 Sep 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CeraVe Group | Experimental | Drug: CeraVe Hydrating Cleanser, Drug: CeraVe Moisturizing CreamParticipants in this group will receive the CeraVe Hydrating Cleanser and Moisturizing Cream for 28 days. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CeraVe Hydrating Cleansertopical cleanser applied twice a day for 28 days | Drug | CeraVe Group |
| CeraVe Moisturizing Creamtopical cream applied twice a day for 28 days | Drug | CeraVe Group |
Primary outcome
Percentage of Participants Reporting Adverse Events (AE)
Time frame: Up to 33 days
As evaluated by treating physician as possibly or probably related to intervention
Number of Participants at Each GAIS Grading Scale
Time frame: At 33 days
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
Time frame: At 33 days
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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Kirsner, MD/PhD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing CeraVe Hydrating Cleanser and CeraVe Moisturizing Cream in people with Diabetes Complications, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Reporting Adverse Events (AE) (time frame: Up to 33 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2022; AzTrials last refreshed its copy on 3 Nov 2026.