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A Study Evaluating the Efficacy of Fluocinonide Cream 0.1% (Vanos) in Subjects With Atopic Dermatitis (Vanos)

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ClinicalTrials.gov Identifier: NCT01049243
Recruitment Status : Completed
First Posted : January 14, 2010
Results First Posted : March 5, 2013
Last Update Posted : August 1, 2018
Sponsor:
Collaborator:
Medicis Pharmaceutical Corporation
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Atopic Dermatitis
Intervention Drug: Fluocinonide Cream 0.1%
Enrollment 20
Recruitment Details Participants were enrolled from IRB approved advertising and the Wake Forest University Health Sciences Dermatology Clininc
Pre-assignment Details  
Arm/Group Title Vanos
Hide Arm/Group Description Single group; 0.1% Cream, One Application, Twice Daily, 14 Days
Period Title: Overall Study
Started 20
Completed 18
Not Completed 2
Arm/Group Title Single Group
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 20 participants
27
(17 to 62)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
9
  45.0%
Male
11
  55.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants
20
1.Primary Outcome
Title Change in Investigator Global Assessment of Atopic Dermatitis Severity From Baseline to Day 2/3.
Hide Description Use of the Investigator's Global Assessment (IGA) score, a subjective scale measuring disease severity. Based on a 6-point scale from 0 (completely clear) to 5 (very severe). Defined score of 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe.
Time Frame Baseline to 3 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single Group
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-0.72  (0.57)
2.Secondary Outcome
Title Change in Investigator Global Assessment of Atopic Dermatitis Severity From Baseline to Day 14.
Hide Description Use of the Investigator's Global Assessment (IGA) score, a subjective scale measuring disease severity. Based on a 6-point scale from 0 (completely clear) to 5 (very severe). Defined score of 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe.
Time Frame Baseline to 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fluocinonide Cream 0.1%
Hide Arm/Group Description:

Fluocinonide Cream 0.1% open label

Fluocinonide Cream 0.1%: 0.1% Cream, One Application, Twice Daily, 14 Days

Overall Number of Participants Analyzed 20
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
2.4
(1.7 to 3.2)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Single Group
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
Single Group
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Single Group
Affected / at Risk (%)
Total   0/20 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Single Group
Affected / at Risk (%)
Total   0/20 (0.00%) 
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
Name/Title: Steven Feldman, MD, PhD
Organization: Wake Forest University Health Sciences
Phone: 336-716-1877
Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT01049243     History of Changes
Other Study ID Numbers: IRB00006468
First Submitted: January 12, 2010
First Posted: January 14, 2010
Results First Submitted: December 21, 2012
Results First Posted: March 5, 2013
Last Update Posted: August 1, 2018