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Evaluation of the Efficacy and Tolerability of Clobetasol Propionate Foam Compared to Vehicle Foam

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00842153
First received: February 11, 2009
Last updated: December 21, 2011
Last verified: September 2011
History of Changes
Results First Received: December 21, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Psoriasis
Interventions: Drug: Clobetasol propionate foam
Drug: Vehicle foam

  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
A wash-out period of 2 to 8 weeks, the duration of which varied by specific medication, was required prior to Visit 1.

Reporting Groups
  Description
Olux-E Foam Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body
Vehicle Foam Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body

Participant Flow:   Overall Study
    Olux-E Foam     Vehicle Foam  
STARTED     28     30  
COMPLETED     27     27  
NOT COMPLETED     1     3  
Adverse Event                 0                 1  
Lost to Follow-up                 1                 2  



  Baseline Characteristics
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Reporting Groups
  Description
Olux-E Foam Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body
Vehicle Foam Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
Total Total of all reporting groups

Baseline Measures
    Olux-E Foam     Vehicle Foam     Total  
Number of Participants  
[units: participants]
 		  28     30     58  
Age  
[units: Years]
Mean ± Standard Deviation 		  54.2  ± 20.0     47.2  ± 13.4     50.6  ± 17.1  
Gender  
[units: Participants]
 		     
Female     12     15     27  
Male     16     15     31  
Race/Ethnicity, Customized  
[units: participants]
 		     
Caucasian     23     23     46  
Black     1     0     1  
Hispanic     0     2     2  
Asian     2     3     5  
Other (not included above; including mixed race)     2     2     4  



  Outcome Measures
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1.  Primary:   Number of Participants With a Target Lesion Global Improvement (TLGI) Score of 0, 1, or 2 at Weeks 1, 2, and 4   [ Time Frame: Weeks 1, 2, and 4 ]
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2.  Secondary:   Number of Participants With a TLGI Score of 0, 1, 2, or 3 at Weeks 1, 2, and 4   [ Time Frame: Weeks 1, 2, and 4 ]
  Show Outcome Measure 2

3.  Secondary:   Number of Participants With a Pruritus (Overall) Score of 0 or 1 at Week 2   [ Time Frame: Week 2 ]
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4.  Secondary:   Number of Participants With an Erythema Score of 0 or 1 at Week 2   [ Time Frame: Week 2 ]
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5.  Secondary:   Number of Participants With a Scaling Score of 0 or 1 at Week 2   [ Time Frame: Week 2 ]
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6.  Secondary:   Number of Participants With a Plaque Thickness Score of 0 or 1 at Week 2   [ Time Frame: Week 2 ]
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7.  Secondary:   Number of Participants With a Score of 0 or 1 for Subject Global Assessment at Week 2   [ Time Frame: Week 2 ]
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8.  Secondary:   Mean Percent Change From Baseline to Week 2 in Pruritus (Target Lesion)   [ Time Frame: Baseline (Week 0) and Week 2 ]
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9.  Secondary:   Mean Percent Change From Baseline to Week 2 in Percent (%) of Body Surface Area (BSA) Affected   [ Time Frame: Baseline (Week 0) and Week 2 ]
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10.  Secondary:   Number of Participants With a TLGI Score of 0, 1, or 2 at Week 1 and Week 4   [ Time Frame: Week 1 and Week 4 ]
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11.  Secondary:   Number of Participants With a Pruritus (Overall) Score of 0 or 1 at Baseline and Week 4   [ Time Frame: Baseline (Week 0) and Week 4 ]
  Show Outcome Measure 11

12.  Secondary:   Number of Participants With an Erythema Score of 0 or 1 at Baseline and Week 4   [ Time Frame: Baseline (Week 0) and Week 4 ]
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13.  Secondary:   Number of Participants With a Scaling Score of 0 or 1 at Baseline and Week 4   [ Time Frame: Baseline (Week 0) and Week 4 ]
  Show Outcome Measure 13

14.  Secondary:   Number of Participants With a Plaque Thickness Score of 0 or 1 at Baseline and Week 4   [ Time Frame: Baseline (Week 0) and Week 4 ]
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15.  Secondary:   Number of Participants With a Score of 0 or 1 for Subject Global Assessment at Baseline and Week 4   [ Time Frame: Baseline (Week 0) and Week 4 ]
  Show Outcome Measure 15

16.  Secondary:   Mean Percent Change From Baseline to Week 4 in Pruritus (Target Lesion)   [ Time Frame: Baseline (Week 0) and Week 4 ]
  Show Outcome Measure 16

17.  Secondary:   Mean Percent Change From Baseline to Week 4 in Percent (%) of Body Surface Area (BSA) Affected   [ Time Frame: Baseline (Week 0) and Week 4 ]
  Show Outcome Measure 17


  Serious Adverse Events
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  Other Adverse Events
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Time Frame No text entered.
Additional Description One participant in the ITT Population was dispensed study drug but did not return after the Baseline visit; thus, this participant was not included in the analysis of serious adverse events (SAEs) or non-serious AEs.

Frequency Threshold
Threshold above which other adverse events are reported   0%  

Reporting Groups
  Description
Olux-E Foam Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body
Vehicle Foam Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body

Other Adverse Events
    Olux-E Foam     Vehicle Foam  
Total, other (not including serious) adverse events      
# participants affected / at risk     3/27     6/30  
General disorders      
Tooth Extraction Surgery † 1    
# participants affected / at risk     1/27 (3.70%)     0/30 (0.00%)  
Hemorrhoids † 1    
# participants affected / at risk     1/27 (3.70%)     0/30 (0.00%)  
Moderately Elevated Prostate-Specific Antigen (PSA) † 1    
# participants affected / at risk     0/27 (0.00%)     1/30 (3.33%)  
Infections and infestations      
Common Cold † 1    
# participants affected / at risk     1/27 (3.70%)     0/30 (0.00%)  
Bronchitis † 1    
# participants affected / at risk     0/27 (0.00%)     1/30 (3.33%)  
Gastrointestinal Virus † 1    
# participants affected / at risk     0/27 (0.00%)     1/30 (3.33%)  
Neoplasms benign, malignant and unspecified (incl cysts and polyps)      
Diagnosed Prostate Cancer † 1    
# participants affected / at risk     0/27 (0.00%)     1/30 (3.33%)  
Respiratory, thoracic and mediastinal disorders      
Sinusitis † 1    
# participants affected / at risk     0/27 (0.00%)     1/30 (3.33%)  
Skin and subcutaneous tissue disorders      
Worsening Of Psoriasis, Upper Extremities † 1    
# participants affected / at risk     0/27 (0.00%)     1/30 (3.33%)  
Papular Dermatitis On Left Upper Abdomen † 1    
# participants affected / at risk     0/27 (0.00%)     1/30 (3.33%)  
Left Shin, Target Area Worse, Severe Itching/Oozing/Wheeping † 1    
# participants affected / at risk     0/27 (0.00%)     1/30 (3.33%)  
† Events were collected by systematic assessment
1 Term from vocabulary, MedDRA



  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
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.  


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


No publications provided


Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00842153     History of Changes
Other Study ID Numbers: OEF0701
Study First Received: February 11, 2009
Results First Received: December 21, 2011
Last Updated: December 21, 2011
Health Authority: Canada: Ethics Review Committee