Ceramide Containing Multivesicular Emulsion Application . . .
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ClinicalTrials.gov Identifier: NCT00947726 |
Recruitment Status :
Completed
First Posted : July 28, 2009
Last Update Posted : April 20, 2011
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Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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Brief Summary:
We believe that using a ceramide based foot cream two times a day for two weeks will prevent water loss and overall foot dryness in patients with non-insulin dependent diabetes.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Foot Transepidermal Water Loss in Patients in NIDDM Foot Dryness in Patients With NIDDM | Drug: CeraVe | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 30 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Ceramide Containing Multivesicular Emulsion Application as a Skin Hydration Treatment for Feet of Subjects With Non-insulin Dependent Diabetes Mellitus. |
Study Start Date : | July 2009 |
Actual Primary Completion Date : | October 2009 |
Resource links provided by the National Library of Medicine

Genetics Home Reference related topics:
Type 2 diabetes
MedlinePlus related topics:
Foot Health
Intervention Details:
- Drug: CeraVe
Using OTC cream on foot twice daily for two weeks.Other Name: Ceramide based foot cream
Primary Outcome Measures :
- Decrease transepidermal water loss and foot dryness in study subjects. [ Time Frame: 5 weeks ]
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- >18 years of age
- non insulin-dependent diabetes
- moderate to severe xerosis of both feet [a score of at least 4 on a scale of 0 (normal) to 8 (deep fissuring)]
- capable of understanding and signing consent form
Exclusion Criteria:
- history of ichthyosis vulgaris
- known hypersensitivity to the topical product used in the study
- previous use of high potency steroids (class I and II) in past 2 week
- presence of acute skin disease or infection, such as vasculitis or cellulitis
- presence of foot ulcer
- evidence of gangrene
No Contacts or Locations Provided
Responsible Party: | Adelaide A. Hebert, MD, The University of Texas Health Science Center at Houston |
ClinicalTrials.gov Identifier: | NCT00947726 History of Changes |
Other Study ID Numbers: |
DK7676 (completed) |
First Posted: | July 28, 2009 Key Record Dates |
Last Update Posted: | April 20, 2011 |
Last Verified: | April 2011 |
Additional relevant MeSH terms:
Diabetes Mellitus, Type 2 Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |