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Ethanol-Free Clobetasol Propionate Foam 0.05% (Olux-E Foam) vs Vehicle Foam in the Treatment of Chronic Hand Dermatitis.

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01323673
First received: March 24, 2011
Last updated: February 23, 2012
Last verified: February 2012
History of Changes
Results First Received: November 17, 2011  
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: Dermatitis, Chronic
Interventions: Drug: clobetasol propionate 0.05%
Drug: Vehicle / Placebo

  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
Olux-E Foam Olux-E foam containing 0.05% clobestasol propionate, applied twice daily (morning and evening [BD]) for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 grams (g) per week
Vehicle Foam Vehicle foam without the active ingredient clobestasol propionate, applied BD for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 g per week

Participant Flow:   Overall Study
    Olux-E Foam     Vehicle Foam  
STARTED     62     63  
COMPLETED     59     58  
NOT COMPLETED     3     5  
Adverse Event                 0                 1  
Lost to Follow-up                 0                 1  
Protocol Violation                 1                 0  
Withdrawal by Subject                 2                 3  



  Baseline Characteristics
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Reporting Groups
  Description
Olux-E Foam Olux-E foam containing 0.05% clobestasol propionate, applied twice daily (morning and evening [BD]) for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 grams (g) per week
Vehicle Foam Vehicle foam without the active ingredient clobestasol propionate, applied BD for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 g per week
Total Total of all reporting groups

Baseline Measures
    Olux-E Foam     Vehicle Foam     Total  
Number of Participants  
[units: participants]
 		  62     63     125  
Age  
[units: Years]
Mean ± Standard Deviation 		  51.5  ± 16.4     47.3  ± 14.3     49.4  ± 15.5  
Gender  
[units: Participants]
 		     
Female     41     29     70  
Male     21     34     55  
Race/Ethnicity, Customized  
[units: participants]
 		     
American Indian or Alaska Native     2     2     4  
Asian     1     2     3  
Black     9     7     16  
Multiracial     1     2     3  
White     49     50     99  



  Outcome Measures
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1.  Primary:   Number of Participants With Improvement of at Least 2 Grades in the Investigator's Static Global Assessment (ISGA) (Target Hand) Score From Baseline to Day 15   [ Time Frame: Baseline (Day 1) and Day 15 ]

Measure Type Primary
Measure Title Number of Participants With Improvement of at Least 2 Grades in the Investigator's Static Global Assessment (ISGA) (Target Hand) Score From Baseline to Day 15
Measure Description The investigator rated chronic hand dermatitis of the participants' target hand using the 5-point ISGA: 0=clear, minor residual discoloration, no erythema (redness of skin)/induration (skin hardening)/papulation (eruption of small, rounded solid bumps on skin), no oozing/crusting; 1=almost clear, trace faint pink erythema, no induration/papulation and no oozing/crusting; 2=mild, faint pink erythema, mild induration/papulation; 3=moderate, pink-red erythema, moderate induration/papulation, some oozing/crusting; 4=Severe, bright-red erythema, severe induration/papulation, oozing/crusting.
Time Frame Baseline (Day 1) and Day 15  
Safety Issue No  

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.
Intent-to-Treat (ITT) Population: all randomized participants who were dispensed study product. Missing values were imputed using last observation carried forward (LOCF, i.e., the last available observation, including Baseline, for a participant was used to estimate subsequent missing data points).

Reporting Groups
  Description
Olux-E Foam Olux-E foam containing 0.05% clobestasol propionate, applied twice daily (morning and evening [BD]) for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 grams (g) per week
Vehicle Foam Vehicle foam without the active ingredient clobestasol propionate, applied BD for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 g per week

Measured Values
    Olux-E Foam     Vehicle Foam  
Number of Participants Analyzed  
[units: participants]
 		  62     63  
Number of Participants With Improvement of at Least 2 Grades in the Investigator's Static Global Assessment (ISGA) (Target Hand) Score From Baseline to Day 15  
[units: participants]
 		  26     18  


Statistical Analysis 1 for Number of Participants With Improvement of at Least 2 Grades in the Investigator's Static Global Assessment (ISGA) (Target Hand) Score From Baseline to Day 15
Groups [1] All groups
Method [2] Cochran-Mantel-Haenszel
P Value [3] 0.151
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Cochran-Mantel-Haenszel (CMH) test stratified by center was used for analysis.



2.  Secondary:   Number of Participants With an Improvement of at Least 1 Grade in the ISGA (Target Hand) Score From Baseline to Day 15   [ Time Frame: Baseline (Day 1) and Day 15 ]

Measure Type Secondary
Measure Title Number of Participants With an Improvement of at Least 1 Grade in the ISGA (Target Hand) Score From Baseline to Day 15
Measure Description The investigator rated chronic hand dermatitis of the participants' target hand using the 5-point ISGA: 0=clear, minor residual discoloration, no erythema (redness of skin)/induration (skin hardening)/papulation (eruption of small, rounded solid bumps on skin), no oozing/crusting; 1=almost clear, trace faint pink erythema, no induration/papulation and no oozing/crusting; 2=mild, faint pink erythema, mild induration/papulation; 3=moderate, pink-red erythema, moderate induration/papulation, some oozing/crusting; 4=Severe, bright-red erythema, severe induration/papulation, oozing/crusting.
Time Frame Baseline (Day 1) and Day 15  
Safety Issue No  

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.
ITT Population. Missing values were imputed using LOCF (i.e., the last available observation, including Baseline, for a participant was used to estimate subsequent missing data points).

Reporting Groups
  Description
Olux-E Foam Olux-E foam containing 0.05% clobestasol propionate, applied twice daily (morning and evening [BD]) for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 grams (g) per week
Vehicle Foam Vehicle foam without the active ingredient clobestasol propionate, applied BD for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 g per week

Measured Values
    Olux-E Foam     Vehicle Foam  
Number of Participants Analyzed  
[units: participants]
 		  62     63  
Number of Participants With an Improvement of at Least 1 Grade in the ISGA (Target Hand) Score From Baseline to Day 15  
[units: participants]
 		  45     38  

No statistical analysis provided for Number of Participants With an Improvement of at Least 1 Grade in the ISGA (Target Hand) Score From Baseline to Day 15



3.  Secondary:   Number of Participants With an Improvement of at Least 2 Grades in the ISGA (Target Hand) Score From Baseline to Day 3 and to Day 8   [ Time Frame: Baseline (Day 1), Day 3, and Day 8 ]

Measure Type Secondary
Measure Title Number of Participants With an Improvement of at Least 2 Grades in the ISGA (Target Hand) Score From Baseline to Day 3 and to Day 8
Measure Description The investigator rated chronic hand dermatitis of the participants' target hand using the 5-point ISGA: 0=clear, minor residual discoloration, no erythema (redness of skin)/induration (skin hardening)/papulation (eruption of small, rounded solid bumps on skin), no oozing/crusting; 1=almost clear, trace faint pink erythema, no induration/papulation and no oozing/crusting; 2=mild, faint pink erythema, mild induration/papulation; 3=moderate, pink-red erythema, moderate induration/papulation, some oozing/crusting; 4=Severe, bright-red erythema, severe induration/papulation, oozing/crusting.
Time Frame Baseline (Day 1), Day 3, and Day 8  
Safety Issue No  

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.
ITT Population. Missing values were imputed using LOCF (i.e., the last available observation, including Baseline, for a participant was used to estimate subsequent missing data points).

Reporting Groups
  Description
Olux-E Foam Olux-E foam containing 0.05% clobestasol propionate, applied twice daily (morning and evening [BD]) for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 grams (g) per week
Vehicle Foam Vehicle foam without the active ingredient clobestasol propionate, applied BD for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 g per week

Measured Values
    Olux-E Foam     Vehicle Foam  
Number of Participants Analyzed  
[units: participants]
 		  62     63  
Number of Participants With an Improvement of at Least 2 Grades in the ISGA (Target Hand) Score From Baseline to Day 3 and to Day 8  
[units: participants]
 		   
Day 3     2     3  
Day 15     12     11  

No statistical analysis provided for Number of Participants With an Improvement of at Least 2 Grades in the ISGA (Target Hand) Score From Baseline to Day 3 and to Day 8



4.  Secondary:   Number of Participants With an Improvement of at Least 1 Grade in the ISGA (Target Hand) Score From Baseline to Day 3 and and to Day 8   [ Time Frame: Baseline (Day 1), Day 3, and Day 8 ]

Measure Type Secondary
Measure Title Number of Participants With an Improvement of at Least 1 Grade in the ISGA (Target Hand) Score From Baseline to Day 3 and and to Day 8
Measure Description The investigator rated chronic hand dermatitis of the participants' target hand using the 5-point ISGA: 0=clear, minor residual discoloration, no erythema (redness of skin)/induration (skin hardening)/papulation (eruption of small, rounded solid bumps on skin), no oozing/crusting; 1=almost clear, trace faint pink erythema, no induration/papulation and no oozing/crusting; 2=mild, faint pink erythema, mild induration/papulation; 3=moderate, pink-red erythema, moderate induration/papulation, some oozing/crusting; 4=Severe, bright-red erythema, severe induration/papulation, oozing/crusting.
Time Frame Baseline (Day 1), Day 3, and Day 8  
Safety Issue No  

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.
ITT Population. Missing values were imputed using LOCF (i.e., the last available observation, including Baseline, for a participant was used to estimate subsequent missing data points).

Reporting Groups
  Description
Olux-E Foam Olux-E foam containing 0.05% clobestasol propionate, applied twice daily (morning and evening [BD]) for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 grams (g) per week
Vehicle Foam Vehicle foam without the active ingredient clobestasol propionate, applied BD for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 g per week

Measured Values
    Olux-E Foam     Vehicle Foam  
Number of Participants Analyzed  
[units: participants]
 		  62     63  
Number of Participants With an Improvement of at Least 1 Grade in the ISGA (Target Hand) Score From Baseline to Day 3 and and to Day 8  
[units: participants]
 		   
Day 3     24     14  
Day 8     36     32  

No statistical analysis provided for Number of Participants With an Improvement of at Least 1 Grade in the ISGA (Target Hand) Score From Baseline to Day 3 and and to Day 8



5.  Secondary:   Number of Participants With an ISGA (Target Hand) Score of 0 or 1 at Days 3, 8, and 15   [ Time Frame: Days 3, 8, and 15 ]

Measure Type Secondary
Measure Title Number of Participants With an ISGA (Target Hand) Score of 0 or 1 at Days 3, 8, and 15
Measure Description The investigator rated chronic hand dermatitis of the participants' target hand using the 5-point ISGA: 0=clear, minor residual discoloration, no erythema (redness of skin)/induration (skin hardening)/papulation (eruption of small, rounded solid bumps on skin), no oozing/crusting; 1=almost clear, trace faint pink erythema, no induration/papulation and no oozing/crusting; 2=mild, faint pink erythema, mild induration/papulation; 3=moderate, pink-red erythema, moderate induration/papulation, some oozing/crusting; 4=Severe, bright-red erythema, severe induration/papulation, oozing/crusting.
Time Frame Days 3, 8, and 15  
Safety Issue No  

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.
ITT Population. Missing values were imputed using LOCF (i.e., the last available observation, including Baseline, for a participant was used to estimate subsequent missing data points).

Reporting Groups
  Description
Olux-E Foam Olux-E foam containing 0.05% clobestasol propionate, applied twice daily (morning and evening [BD]) for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 grams (g) per week
Vehicle Foam Vehicle foam without the active ingredient clobestasol propionate, applied BD for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 g per week

Measured Values
    Olux-E Foam     Vehicle Foam  
Number of Participants Analyzed  
[units: participants]
 		  62     63  
Number of Participants With an ISGA (Target Hand) Score of 0 or 1 at Days 3, 8, and 15  
[units: participants]
 		   
Day 3     2     2  
Day 8     11     9  
Day 15     24     17  

No statistical analysis provided for Number of Participants With an ISGA (Target Hand) Score of 0 or 1 at Days 3, 8, and 15



6.  Secondary:   Number of Participants With an Improvement of at Least 1 Grade in the Subject Global Assessment (SGA) (Target Hand) Score From Baseline to Days 3, 8, and 15   [ Time Frame: Baseline (Day 1) and Days 3, 8, and 15 ]

Measure Type Secondary
Measure Title Number of Participants With an Improvement of at Least 1 Grade in the Subject Global Assessment (SGA) (Target Hand) Score From Baseline to Days 3, 8, and 15
Measure Description On Days 1, 3, 8, and 15 prior to the investigator assessment, participants rated chronic hand dermatitis of the target hand using the 5-point SGA: 0=skin is clear; 1=dermatitis in minimal, there may be a few light-pink areas; 2=dermatitis is mild, there may be occasional light-pink areas; 3=dermatitis is moderate, there may be easily noticeable pink-red areas; 4=dermatitis is severe, there may be deep or bright-red areas that may be warm to the touch.
Time Frame Baseline (Day 1) and Days 3, 8, and 15  
Safety Issue No  

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.
ITT Population. Missing values were imputed using LOCF (i.e., the last available observation, including Baseline, for a participant was used to estimate subsequent missing data points).

Reporting Groups
  Description
Olux-E Foam Olux-E foam containing 0.05% clobestasol propionate, applied twice daily (morning and evening [BD]) for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 grams (g) per week
Vehicle Foam Vehicle foam without the active ingredient clobestasol propionate, applied BD for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 g per week

Measured Values
    Olux-E Foam     Vehicle Foam  
Number of Participants Analyzed  
[units: participants]
 		  62     63  
Number of Participants With an Improvement of at Least 1 Grade in the Subject Global Assessment (SGA) (Target Hand) Score From Baseline to Days 3, 8, and 15  
[units: participants]
 		   
Day 3     28     25  
Day 8     44     35  
Day 15     51     33  

No statistical analysis provided for Number of Participants With an Improvement of at Least 1 Grade in the Subject Global Assessment (SGA) (Target Hand) Score From Baseline to Days 3, 8, and 15



7.  Secondary:   Number of Participants With an SGA (Target Hand) Score of 0 or 1 at Days 3, 8, and 15   [ Time Frame: Days 3, 8, and 15 ]

Measure Type Secondary
Measure Title Number of Participants With an SGA (Target Hand) Score of 0 or 1 at Days 3, 8, and 15
Measure Description On Days 1, 3, 8, and 15 prior to the investigator assessment, participants rated chronic hand dermatitis of the target hand using the 5-point SGA: 0=skin is clear; 1=dermatitis in minimal, there may be a few light-pink areas; 2=dermatitis is mild, there may be occasional light-pink areas; 3=dermatitis is moderate, there may be easily noticeable pink-red areas; 4=dermatitis is severe, there may be deep or bright-red areas that may be warm to the touch.
Time Frame Days 3, 8, and 15  
Safety Issue No  

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.
ITT Population. Missing values were imputed using LOCF (i.e., the last available observation, including Baseline, for a participant was used to estimate subsequent missing data points).

Reporting Groups
  Description
Olux-E Foam Olux-E foam containing 0.05% clobestasol propionate, applied twice daily (morning and evening [BD]) for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 grams (g) per week
Vehicle Foam Vehicle foam without the active ingredient clobestasol propionate, applied BD for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 g per week

Measured Values
    Olux-E Foam     Vehicle Foam  
Number of Participants Analyzed  
[units: participants]
 		  62     63  
Number of Participants With an SGA (Target Hand) Score of 0 or 1 at Days 3, 8, and 15  
[units: participants]
 		   
Day 3     7     4  
Day 8     16     10  
Day 15     32     14  

No statistical analysis provided for Number of Participants With an SGA (Target Hand) Score of 0 or 1 at Days 3, 8, and 15



8.  Secondary:   Percent Change From Baseline in Pruritus, Stinging, Burning, and Pain Scores (Target Hand) at Days 3, 8, and 15   [ Time Frame: Baseline (Day 1) and Days 3, 8, and 15 ]

Measure Type Secondary
Measure Title Percent Change From Baseline in Pruritus, Stinging, Burning, and Pain Scores (Target Hand) at Days 3, 8, and 15
Measure Description On Days 1, 3, 8, and 15, participants assessed the pruritis (itching), stinging (piercing pain), burning, and pain of the target hand. Participants were instructed to assess the level/severity of the indicated symptoms over the previous 24 hours using a scale ranging from 0 (none) to 10 (unbearable). Percent change from baseline was calculated as value at Days 3, 8, and 15 minus the value at Baseline divided by the Baseline value * 100.
Time Frame Baseline (Day 1) and Days 3, 8, and 15  
Safety Issue No  

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.
ITT Population. Only those participants contributing data at the indicated time points were analyzed.

Reporting Groups
  Description
Olux-E Foam Olux-E foam containing 0.05% clobestasol propionate, applied twice daily (morning and evening [BD]) for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 grams (g) per week
Vehicle Foam Vehicle foam without the active ingredient clobestasol propionate, applied BD for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 g per week

Measured Values
    Olux-E Foam     Vehicle Foam  
Number of Participants Analyzed  
[units: participants]
 		  60     60  
Percent Change From Baseline in Pruritus, Stinging, Burning, and Pain Scores (Target Hand) at Days 3, 8, and 15  
[units: Percent change in scores on a scale]
Mean ± Standard Deviation 		   
Pruritus, Day 3, n=58, 58     -29.4  ± 38.66     -11.5  ± 52.76  
Pruritus, Day 8, n=57, 57     -48.3  ± 46.38     -20.3  ± 62.98  
Pruritus, Day 15, n=60, 59     -65.7  ± 38.25     -25.3  ± 58.18  
Stinging, Day 3, n=57, 60     -27.8  ± 37.86     -1.84  ± 85.43  
Stinging, Day 8, n=56, 58     -49.2  ± 47.25     -22.9  ± 59.17  
Stinging, Day 15, n=58, 59     -63.1  ± 40.63     -28.9  ± 48.48  
Burning, Day 3, n=57, 59     -26.4  ± 40.77     -10.4  ± 84.39  
Burning, Day 8, n=55, 58     -49.7  ± 49.87     -26.1  ± 61.75  
Burning, Day 15, n=59, 60     -63.2  ± 45.46     -31.1  ± 55.67  
Pain, Day 3, n=56, 58     -22.9  ± 54.80     -21.0  ± 81.02  
Pain, Day 8, n=57, 56     -40.2  ± 52.25     -21.5  ± 76.75  
Pain, Day 15, n=60, 59     -60.6  ± 41.76     -35.5  ± 57.54  

No statistical analysis provided for Percent Change From Baseline in Pruritus, Stinging, Burning, and Pain Scores (Target Hand) at Days 3, 8, and 15




  Serious Adverse Events
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  Other Adverse Events
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  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: NCT01323673     History of Changes
Other Study ID Numbers: 115054
Study First Received: March 24, 2011
Results First Received: November 17, 2011
Last Updated: February 23, 2012
Health Authority: United States: Food and Drug Administration