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Ceramide Containing Multivesicular Emulsion Application . . .

This study has been completed.
Sponsor:
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00947726
First received: July 27, 2009
Last updated: April 18, 2011
Last verified: April 2011
History of Changes
  Purpose

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 Intervention
Foot Transepidermal Water Loss in Patients in NIDDM
Foot Dryness in Patients With NIDDM
 Drug: CeraVe

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:
  • Decrease transepidermal water loss and foot dryness in study subjects. [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: July 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: CeraVe
    Using OTC cream on foot twice daily for two weeks.
    Other Name: Ceramide based foot cream
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications 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)
Study First Received: July 27, 2009
Last Updated: April 18, 2011
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on June 18, 2013