A Phase 4 interventional study of CeraVe Hydrating Cleanser and CeraVe Moisturizing Cream in Diabetes Complications, sponsored by University of Miami. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-09-22.
Sponsored by University of Miami · Phase 4, Interventional, and Treatment
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.
10,923 studies on the registry are indexed under Diabetes Mellitus; 1,318 are open to participants now.
This study's enrollment of 528 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →University of Miami is the lead sponsor of 820 studies on the registry; 161 are open to participants now.
Of its 111 completed or terminated interventional studies of FDA-regulated products, 93 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants in this group will receive the CeraVe Hydrating Cleanser and Moisturizing Cream for 28 days.
Drug: CeraVe Hydrating Cleanser · Drug: CeraVe Moisturizing Cream
topical cleanser applied twice a day for 28 days
topical cream applied twice a day for 28 days
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
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
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
| Milestone | CeraVe Group |
|---|---|
| Started | 528 |
| Completed | 528 |
| Not completed | 0 |
As evaluated by treating physician as possibly or probably related to intervention
| percentage of participants | CeraVe Group |
|---|---|
| Percentage of Participants Reporting Adverse Events (AE) | 0 |
As evaluated by treating physician as possibly or probably related to intervention
| percentage of participants | CeraVe Group |
|---|---|
| Percentage of Participants Reporting Adverse Events (AE) | 0 |
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.
| Participants | CeraVe Group |
|---|---|
| Very much improved | 223 |
| Much improved | 224 |
| Improved | 72 |
| No change | 9 |
| Worse | 0 |
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).
| Participants | CeraVe Group |
|---|---|
| Roughness/scaling - none | 271 |
| Roughness/scaling - Almost None | 219 |
| Roughness/scaling - Mild | 28 |
| Roughness/scaling - Moderate | 7 |
| Roughness/scaling - Severe | 3 |
| Itchiness - None | 386 |
| Itchiness - Almost None | 116 |
| Itchiness - Mild | 21 |
| Itchiness - Moderate | 1 |
| Itchiness - Severe | 4 |
| Pain - None | 494 |
| Pain - Almost | 27 |
| Pain - Mild | 4 |
| Pain - Moderate | 1 |
| Pain - Severe | 2 |
| Erythema - None | 409 |
| Erythema - Almost None | 93 |
| Erythema - Mild | 19 |
| Erythema - Moderate | 6 |
| Erythema - Severe | 1 |
| Fissures - None | 408 |
| Fissures - Almost None | 104 |
| Fissures - Mild | 14 |
| Fissures - Moderate | 0 |
| Fissures - Severe | 2 |
Collected over 33 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CeraVe Group | 0/528 (0%) | 0/528 (0%) | 0/528 (0%) |
| Age, Continuous(years) | CeraVe Group |
|---|---|
| Mean | 57.8 ± 12.3 |
| Sex: Female, Male(Participants) | CeraVe Group |
|---|---|
| Female | 327 |
| Male | 201 |
| Race and Ethnicity Not Collected(Participants) | CeraVe Group |
|---|
| Diabetes mellitus type(Participants) | CeraVe Group |
|---|---|
| Type 1 | 92 |
| Type 2 | 436 |
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Plan to share: No
This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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