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Desoximetasone Spray 0.05%, 0.25%; Dose Ranging Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Taro Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT01018134
First received: November 19, 2009
Last updated: July 9, 2014
Last verified: July 2014
Results First Received: January 31, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Psoriasis
Interventions: Drug: Desoximetasone 0.05% once daily
Drug: Desoximetasone 0.05% twice daily
Drug: Desoximetasone 0.25% once daily
Drug: Vehicle once daily
Drug: Vehicle twice daily

  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
Desoximetasone 0.05% Once Daily

Desoximetasone topical spray 0.05% administered once daily to affected area

Desoximetasone 0.05% once daily: Desoximetasone topical spray 0.05% administered to affected area once daily for 28 days

Desoximetasone 0.05% Twice Daily

Desoximetasone topical spray 0.05% administered twice daily to affected area

Desoximetasone 0.05% twice daily: Desoximetasone topical spray 0.05% administered to affected area twice daily for 28 days

Desoximetasone 0.25% Once Daily

Desoximetasone topical spray 0.25% administered once daily to affected area

Desoximetasone 0.25% once daily: Desoximetasone topical spray 0.25% administered to affected area once daily for 28 days

Desoximetasone 0.25% Twice Daily

Desoximetasone topical spray 0.25% administered twice daily to affected area

Desoximetasone 0.25% once daily: Desoximetasone topical spray 0.25% administered to affected areas twice daily for 28 days

Vehicle Once Daily

Vehicle administered to affected areas once daily

Vehicle once daily: Vehicle topical spray administered to affected areas once daily for 28 days

Vehicle Twice Daily

Vehicle administered to affected areas twice daily

Vehicle twice daily: Vehicle topical spray administered to affected areas twice daily for 28 days


Participant Flow:   Overall Study
    Desoximetasone 0.05% Once Daily   Desoximetasone 0.05% Twice Daily   Desoximetasone 0.25% Once Daily   Desoximetasone 0.25% Twice Daily   Vehicle Once Daily   Vehicle Twice Daily
STARTED   30   31   30   29 [1]   15   15 
COMPLETED   30   30   29   29   15   15 
NOT COMPLETED   0   1   1   0   0   0 
[1] 30 enrolled patients, one who did not use the study medication was excluded from all analyses



  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
Desoximetasone 0.05% Once Daily

Desoximetasone topical spray 0.05% administered once daily to affected area

Desoximetasone 0.05% once daily: Desoximetasone topical spray 0.05% administered to affected area once daily for 28 days

Desoximetasone 0.05% Twice Daily

Desoximetasone topical spray 0.05% administered twice daily to affected area

Desoximetasone 0.05% twice daily: Desoximetasone topical spray 0.05% administered to affected area twice daily for 28 days

Desoximetasone 0.25% Once Daily

Desoximetasone topical spray 0.25% administered once daily to affected area

Desoximetasone 0.25% once daily: Desoximetasone topical spray 0.25% administered to affected area once daily for 28 days

Desoximetasone 0.25% Twice Daily

Desoximetasone topical spray 0.25% administered twice daily to affected area

Desoximetasone 0.25% once daily: Desoximetasone topical spray 0.25% administered to affected areas twice daily for 28 days

Vehicle Once Daily

Vehicle administered to affected areas once daily

Vehicle once daily: Vehicle topical spray administered to affected areas once daily for 28 days

Vehicle Twice Daily

Vehicle administered to affected areas twice daily

Vehicle twice daily: Vehicle topical spray administered to affected areas twice daily for 28 days

Total Total of all reporting groups

Baseline Measures
   Desoximetasone 0.05% Once Daily   Desoximetasone 0.05% Twice Daily   Desoximetasone 0.25% Once Daily   Desoximetasone 0.25% Twice Daily   Vehicle Once Daily   Vehicle Twice Daily   Total 
Overall Participants Analyzed 
[Units: Participants]
 30   31   30   29   15   15   150 
Age 
[Units: Years]
Mean (Standard Deviation)
 53.60  (15.21)   45.06  (13.04)   51.60  (12.67)   50.62  (14.54)   53.53  (12.92)   49.60  (13.30)   50.66  (13.61) 
Gender 
[Units: Participants]
             
Female   12   13   14   11   1   7   58 
Male   18   18   16   18   14   8   92 
Region of Enrollment 
[Units: Participants]
             
United States   30   31   30   29   15   15   150 


  Outcome Measures
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1.  Primary:   Number of Participants in Each Treatment Group With Clinical Cure: Physician's Global Assessment (PGA) Score = 0 or 1 at Day 28   [ Time Frame: 28 days ]

2.  Primary:   Number of Participants in Each Treatment Group With Treatment Success for the Target Lesion (Total Lesion Severity Scale (TLSS) a Score of 0 or 1).   [ Time Frame: Day 28 ]

3.  Secondary:   Mean Change From Baseline in PGA Score at Day 28 Using the ITT   [ Time Frame: Day 28 ]

4.  Secondary:   Mean Change From Baseline in Total Lesion Severity Score (TLSS) at Day 28   [ Time Frame: Day 28 ]

5.  Secondary:   Mean Change From Baseline in %Body Surface Area (%BSA) Affected at Day 28 (or Early Termination).   [ Time Frame: Day 28 ]


  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
No text entered.


  More Information
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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: Director, Clinical Research
Organization: Taro Pharmaceuticals U.S.A., Inc.
phone: 914-345-9001
e-mail: natalie.yantovskiy@taro.com



Responsible Party: Taro Pharmaceuticals USA
ClinicalTrials.gov Identifier: NCT01018134     History of Changes
Other Study ID Numbers: DSXS 0906.00
70915004 ( Other Identifier: Novum PRS )
Study First Received: November 19, 2009
Results First Received: January 31, 2014
Last Updated: July 9, 2014
Health Authority: United States: Food and Drug Administration