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
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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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

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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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 ]

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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 ]

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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 ]

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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 ]

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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 ]

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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 ]

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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 ]

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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 ]

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.

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
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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

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