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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
Sponsor:
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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

MedlinePlus related topics: Foot Health
U.S. FDA Resources


Intervention Details:
    Drug: CeraVe
    Using OTC cream on foot twice daily for two weeks.
    Other Name: Ceramide based foot cream


Primary Outcome Measures :
  1. 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, Senior)
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

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