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Clinical Trials/NCT00947726
NCT00947726CompletedNot Applicable

Ceramide Containing Multivesicular Emulsion Application as a Skin Hydration Treatment for Feet of Subjects With Non-insulin Dependent Diabetes Mellitus.

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)0 sites10 target enrollmentStarted: July 1, 2009Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
10
Primary Endpoint
Decrease transepidermal water loss and foot dryness in study subjects.
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

CeraVe

Experimental

Ceramide based foot cream twice daily for two weeks

Intervention: CeraVe (Other)

Outcomes

Primary Outcomes

Decrease transepidermal water loss and foot dryness in study subjects.

Time Frame: Baseline and 5 weeks

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Nih
Responsible Party
Sponsor

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