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| Name | Class |
|---|---|
| CeraVe | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CeraVe Group | Experimental | Participants in this group will receive the CeraVe Hydrating Cleanser and Moisturizing Cream for 28 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CeraVe Hydrating Cleanser | Drug | topical cleanser applied twice a day for 28 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Kirsner, MD/PhD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33136 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | CeraVe Group | Participants in this group will receive the CeraVe Hydrating Cleanser and Moisturizing Cream for 28 days. CeraVe Hydrating Cleanser: topical cleanser applied twice a day for 28 days CeraVe Moisturizing Cream: topical cream applied twice a day for 28 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CeraVe Group | Participants in this group will receive the CeraVe Hydrating Cleanser and Moisturizing Cream for 28 days. CeraVe Hydrating Cleanser: topical cleanser applied twice a day for 28 days CeraVe Moisturizing Cream: topical cream applied twice a day for 28 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Reporting Adverse Events (AE) | As evaluated by treating physician as possibly or probably related to intervention | Posted | Number | percentage of participants | Up to 33 days |
|
|
33 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CeraVe Group | Participants in this group will receive the CeraVe Hydrating Cleanser and Moisturizing Cream for 28 days. CeraVe Hydrating Cleanser: topical cleanser applied twice a day for 28 days CeraVe Moisturizing Cream: topical cream applied twice a day for 28 days |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert Kirsner | University of Miami | 305-689-2646 | rkirsner@med.miami.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 24, 2020 | Aug 18, 2022 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D048909 | Diabetes Complications |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
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| CeraVe Moisturizing Cream |
| Drug |
topical cream applied twice a day for 28 days |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Diabetes mellitus type | Count of Participants | Participants |
|
|
| Primary | Percentage of Participants Reporting Adverse Events (AE) | As evaluated by treating physician as possibly or probably related to intervention | Posted | Number | percentage of participants | Up to 33 days |
|
|
|
| Primary | 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. | Posted | Count of Participants | Participants | At 33 days |
|
|
|
| Primary | 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). | Posted | Count of Participants | Participants | At 33 days |
|
|
|
| 0 |
| 528 |
| 0 |
| 528 |
| 0 |
| 528 |
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| Title | Measurements |
|---|---|
|
| No change |
|
| Worse |
|
| Title | Measurements |
|---|---|
|
| Roughness/scaling - Moderate |
|
| Roughness/scaling - Severe |
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| Itchiness - None |
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| Itchiness - Almost None |
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| Itchiness - Mild |
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| Itchiness - Moderate |
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| Itchiness - Severe |
|
| Pain - None |
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| Pain - Almost |
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| Pain - Mild |
|
| Pain - Moderate |
|
| Pain - Severe |
|
| Erythema - None |
|
| Erythema - Almost None |
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| Erythema - Mild |
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| Erythema - Moderate |
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| Erythema - Severe |
|
| Fissures - None |
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| Fissures - Almost None |
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| Fissures - Mild |
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| Fissures - Moderate |
|
| Fissures - Severe |
|