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Efficacy of Fluocinonide Cream 0.1% (Vanos(R)) in Reducing Itch in Subjects With Atopic Dermatitis

This study has been completed.
Sponsor:
Collaborator:
Medicis Pharmaceutical Corporation
Information provided by (Responsible Party):
Steven R. Feldman, Wake Forest University Health Sciences
ClinicalTrials.gov Identifier:
NCT01469767
First received: November 7, 2011
Last updated: April 27, 2017
Last verified: April 2017
Results First Received: January 27, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: No masking;   Primary Purpose: Treatment
Condition: Atopic Dermatitis
Intervention: Drug: Fluocinonide cream

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Fluocinonide Cream

Subjects will apply fluocinonide cream 0.1% twice daily for 5 days.

Fluocinonide cream: Fluocinonide cream 0.1% applied twice daily for 5 days.


Participant Flow:   Overall Study
    Fluocinonide Cream
STARTED   10 
COMPLETED   10 
NOT COMPLETED   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Fluocinonide Cream

Subjects will apply fluocinonide cream 0.1% twice daily for 5 days.

Fluocinonide cream: Fluocinonide cream 0.1% applied twice daily for 5 days.


Baseline Measures
   Fluocinonide Cream 
Overall Participants Analyzed 
[Units: Participants]
 10 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      3  30.0% 
Between 18 and 65 years      6  60.0% 
>=65 years      1  10.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      7  70.0% 
Male      3  30.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      4  40.0% 
White      6  60.0% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 
Region of Enrollment 
[Units: Participants]
 
United States   10 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   IGA   [ Time Frame: 14 days ]

2.  Secondary:   Actigraphy   [ Time Frame: 14 days ]

3.  Secondary:   EASI   [ Time Frame: 14 days ]

4.  Secondary:   BSA   [ Time Frame: 14 days ]

5.  Secondary:   VAS   [ Time Frame: 14 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Steve Feldman MD
Organization: Wake Forest University Health Sciences
phone: 336-716=3775
e-mail: sfeldman@wakehealth.edu



Responsible Party: Steven R. Feldman, Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT01469767     History of Changes
Other Study ID Numbers: 00018876
Study First Received: November 7, 2011
Results First Received: January 27, 2017
Last Updated: April 27, 2017