Ceramide Containing Multivesicular Emulsion Application . . .

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

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 Overview

• Status: Completed
• Conditions: Foot Transepidermal Water Loss in Patients in NIDDM; Foot Dryness in Patients With NIDDM
• Intervention / Treatment: Other: CeraVe

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CeraVe; Ceramide based foot cream twice daily for two weeks	Other: CeraVe; Using over the counter (OTC) cream on foot twice daily for two weeks.; Other Names: Ceramide based foot cream

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Decrease transepidermal water loss and foot dryness in study subjects.	Baseline and 5 weeks

Collaborators and Investigators

• Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Collaborators: The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Actual): July 31, 2010
• Study Completion (Actual): July 31, 2010

Study Registration Dates

• First Submitted: July 27, 2009
• First Submitted That Met QC Criteria: July 27, 2009
• First Posted (Estimated): July 28, 2009

Study Record Updates

• Last Update Posted (Actual): February 20, 2026
• Last Update Submitted That Met QC Criteria: February 18, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: DK7676 (completed); T35DK007676 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No