Diabetes Complications
Conditions
Keywords
cutaneous complication of DM
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.
Interventions
DRUGCeraVe Hydrating Cleanser
topical cleanser applied twice a day for 28 days
topical cream applied twice a day for 28 days
Sponsors
CeraVe
University of Miami
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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: 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Reporting Adverse Events (AE) | Up to 33 days | As evaluated by treating physician as possibly or probably related to intervention |
| Number of Participants at Each GAIS Grading Scale | 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 | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 528 |
| Total | 528 |
Baseline characteristics
| Characteristic | CeraVe Group | — |
|---|---|---|
| Age, Continuous | 57.8 years STANDARD_DEVIATION 12.3 | — |
| Diabetes mellitus type Type 1 | 92 Participants | — |
| Diabetes mellitus type Type 2 | 436 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 327 Participants | — |
| Sex: Female, Male Male | 201 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 528 |
| other Total, other adverse events | 0 / 528 |
| serious Total, serious adverse events | 0 / 528 |
Outcome results
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).
Time frame: At 33 days
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CeraVe Group | Number of Participants at Each Dry Skin Scale | Roughness/scaling - none | 271 Participants |
| CeraVe Group | Number of Participants at Each Dry Skin Scale | Roughness/scaling - Almost None | 219 Participants |
| CeraVe Group | Number of Participants at Each Dry Skin Scale | Roughness/scaling - Mild | 28 Participants |
| CeraVe Group | Number of Participants at Each Dry Skin Scale | Roughness/scaling - Moderate | 7 Participants |
| CeraVe Group | Number of Participants at Each Dry Skin Scale | Roughness/scaling - Severe | 3 Participants |
| CeraVe Group | Number of Participants at Each Dry Skin Scale | Itchiness - None | 386 Participants |
| CeraVe Group | Number of Participants at Each Dry Skin Scale | Itchiness - Almost None | 116 Participants |
| CeraVe Group | Number of Participants at Each Dry Skin Scale | Itchiness - Mild | 21 Participants |
| CeraVe Group | Number of Participants at Each Dry Skin Scale | Itchiness - Moderate | 1 Participants |
| CeraVe Group | Number of Participants at Each Dry Skin Scale | Itchiness - Severe | 4 Participants |
| CeraVe Group | Number of Participants at Each Dry Skin Scale | Pain - None | 494 Participants |
| CeraVe Group | Number of Participants at Each Dry Skin Scale | Pain - Almost | 27 Participants |
| CeraVe Group | Number of Participants at Each Dry Skin Scale | Pain - Mild | 4 Participants |
| CeraVe Group | Number of Participants at Each Dry Skin Scale | Pain - Moderate | 1 Participants |
| CeraVe Group | Number of Participants at Each Dry Skin Scale | Pain - Severe | 2 Participants |
| CeraVe Group | Number of Participants at Each Dry Skin Scale | Erythema - None | 409 Participants |
| CeraVe Group | Number of Participants at Each Dry Skin Scale | Erythema - Almost None | 93 Participants |
| CeraVe Group | Number of Participants at Each Dry Skin Scale | Erythema - Mild | 19 Participants |
| CeraVe Group | Number of Participants at Each Dry Skin Scale | Erythema - Moderate | 6 Participants |
| CeraVe Group | Number of Participants at Each Dry Skin Scale | Erythema - Severe | 1 Participants |
| CeraVe Group | Number of Participants at Each Dry Skin Scale | Fissures - None | 408 Participants |
| CeraVe Group | Number of Participants at Each Dry Skin Scale | Fissures - Almost None | 104 Participants |
| CeraVe Group | Number of Participants at Each Dry Skin Scale | Fissures - Mild | 14 Participants |
| CeraVe Group | Number of Participants at Each Dry Skin Scale | Fissures - Moderate | 0 Participants |
| CeraVe Group | Number of Participants at Each Dry Skin Scale | Fissures - Severe | 2 Participants |
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.
Time frame: At 33 days
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CeraVe Group | Number of Participants at Each GAIS Grading Scale | Very much improved | 223 Participants |
| CeraVe Group | Number of Participants at Each GAIS Grading Scale | Much improved | 224 Participants |
| CeraVe Group | Number of Participants at Each GAIS Grading Scale | Improved | 72 Participants |
| CeraVe Group | Number of Participants at Each GAIS Grading Scale | No change | 9 Participants |
| CeraVe Group | Number of Participants at Each GAIS Grading Scale | Worse | 0 Participants |
Primary
Percentage of Participants Reporting Adverse Events (AE)
As evaluated by treating physician as possibly or probably related to intervention
Time frame: Up to 33 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CeraVe Group | Percentage of Participants Reporting Adverse Events (AE) | 0 percentage of participants |
Primary
Percentage of Participants Reporting Adverse Events (AE)
As evaluated by treating physician as possibly or probably related to intervention
Time frame: Up to 33 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CeraVe Group | Percentage of Participants Reporting Adverse Events (AE) | 0 percentage of participants |