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VANOS Cream and Skin Barrier Function

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ClinicalTrials.gov Identifier: NCT00819507
Recruitment Status : Completed
First Posted : January 9, 2009
Results First Posted : July 11, 2017
Last Update Posted : July 11, 2017
Sponsor:
Collaborator:
Medicis Pharmaceutical Corporation
Information provided by (Responsible Party):
Eric Simpson, Oregon Health and Science University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Atopic Dermatitis
Intervention Drug: Fluocinonide
Enrollment 25
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Vanos Cream
Hide Arm/Group Description

glucocorticoid cream

Fluocinonide: Fluocinonide 0.1% cream topical daily for two weeks

Period Title: Overall Study
Started 25
Completed 25
Not Completed 0
Arm/Group Title Vanos Cream
Hide Arm/Group Description

glucocorticoid cream

Fluocinonide: Fluocinonide 0.1% cream topical daily for two weeks

Overall Number of Baseline Participants 25
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 25 participants
39
(17 to 67)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
Female
14
  56.0%
Male
11
  44.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
Caucasian, Non-Hispanic
19
  76.0%
African-American
2
   8.0%
Asian
2
   8.0%
Hispanic
1
   4.0%
Mixed race
1
   4.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 25 participants
25
1.Primary Outcome
Title Change in Eczema Severity and Area Index
Hide Description The eczema area and severity index (EAS I) is a validated composite score measuring physical signs of atopic dermatitis. The scale ranges from 0-72. The components measuring severity are four signs/symptoms of atopic dermatitis: erythema, population, excoriation and lichenification on a scale of 0-3 for each body of the four body regions (head/neck, trunk, arms, legs). The component measuring area is a body surface area measurement of each region. The area and severity of each body region is weighted based on size of region which are added together for the complete score. The score for each patient's with scores between 0 and 7 are considered mild ,between 7 and 21 are considered moderate, and greater than 21 are considered severe. In this study the change in EASI score between baseline and end of study (baseline EASI subtracted from end of study EASI) was calculated as a final outcome data point.
Time Frame 2 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vanos Cream
Hide Arm/Group Description:

glucocorticoid cream

Fluocinonide: Fluocinonide 0.1% cream topical daily for two weeks

Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: units
6.01  (7.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vanos Cream
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 6.01
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change in Transepidermal Water Loss
Hide Description A measure of water flux out the skin using a small non-invasive probe. Values can range between 0-no water loss and over 100-severe water loss. This measure indicates the degree of skin barrier permeability with lower values indicating lower permeability (improved skin barrier function).
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vanos Cream
Hide Arm/Group Description:

glucocorticoid cream

Fluocinonide: Fluocinonide 0.1% cream topical daily for two weeks

Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: G/m^2/hr
14.35  (16)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vanos Cream
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 14.35
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Vanos Cream
Hide Arm/Group Description

glucocorticoid cream

Fluocinonide: Fluocinonide 0.1% cream topical daily for two weeks

All-Cause Mortality
Vanos Cream
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Vanos Cream
Affected / at Risk (%) # Events
Total   0/25 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Vanos Cream
Affected / at Risk (%) # Events
Total   1/25 (4.00%)    
Skin and subcutaneous tissue disorders   
burning * [1]  1/25 (4.00%)  1
*
Indicates events were collected by non-systematic assessment
[1]
burning for 2 days, rated as mild
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Eric Simpson
Organization: Oregon Health & Science University
Phone: 503-494-2121
EMail: simpsone@ohsu.edu
Layout table for additonal information
Responsible Party: Eric Simpson, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00819507     History of Changes
Other Study ID Numbers: 4590
First Submitted: January 8, 2009
First Posted: January 9, 2009
Results First Submitted: May 17, 2017
Results First Posted: July 11, 2017
Last Update Posted: July 11, 2017