Ceramide Containing Multivesicular Emulsion Application .... | NCT00947726

Studies
Ceramide Containing Multivesicular Emulsion Application . . .

NCT00947726

Sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Status

Completed

Last Update Posted

Feb 20, 2026Actual

Enrollment

10Actual

Phase

Not Applicable

Conditions

Foot Transepidermal Water Loss in Patients in NIDDM
Foot Dryness in Patients With NIDDM

Interventions

CeraVe

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
T35DK007676	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2009

Primary Completion Date

Jul 31, 2010Actual

Completion Date

Jul 31, 2010Actual

First Submitted Date

Jul 27, 2009

First Submission Date that Met QC Criteria

Jul 27, 2009

First Posted Date

Jul 28, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 18, 2026

Last Update Posted Date

Feb 20, 2026Actual

Name	Class
The University of Texas Health Science Center, Houston	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CeraVe	Experimental	Ceramide based foot cream twice daily for two weeks	Other: CeraVe

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CeraVe	Other	Using over the counter (OTC) cream on foot twice daily for two weeks.	CeraVe

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided