GSK: Protocol Summary for 115054

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Protocol Summary for 115054

Protocol Summary
Protocol Id:	115054
Secondary Ids:
Title:	Ethanol-Free Clobetasol Propionate Foam 0.05% (Olux-E Foam) vs Vehicle Foam in the Treatment of Chronic Hand Dermatitis.
Phase:	phase 4
Acronym:
FDA Regulated Intervention?:	Yes
Section 801 Clinical Trial?:	Yes
Delayed Posting:	No
IND/IDE Protocol?:	no
Study Type:	Interventional
Oversight Authority:	United States: Food & Drug Administration
Collaborators:	N/A GSK
Brief Summary:	The purpose of this study is to determine how clobetasol proprionate foam works against a placebo foam in the treatment of hand dermatitis.
Detailed Description:	Topical corticosteroids have anti-inflammatory, immunosuppressive and antiproliferative properties. Clobetasol propionate foam 0.05% (Olux-E), a Class 1 corticosteroid, is formulated in an ethanol free petrolatum base that provides the benefits of a super-potent corticosteroid combined with moisturizing ingredients in the treatment of corticosteroid responsive dermatoses. The current study is designed to show efficacy and safety in the treatment of moderate to severe chronic hand dermatitis.
Record Verification Date:	August 2011
Status:	Completed
Why Study Stopped:
Study Start Date:	November 2010
Study Completion Date:	March 2011
Study Completion Date Type:	Actual
Primary Completion Date:	March 2011
Primary Completion Date Type:	Actual
Primary Purpose:	treatment
Allocation:	Randomized
Masking:	Double Blind
Masked Subject:	yes
Masked Caregiver:	yes
Masked Investigator:	yes
Masked Assessor:	yes
Study Design (Assignment):	Parallel Assignment
Study Classification (Endpoint):	Safety/Efficacy Study
Primary Outcomes:	The proportion of subjects who achieve treatment success, improvement on the ISGA (Investigator Static Global Assessment) for the target hand 15 days
Secondary Outcomes:
Conditions:	Dermatitis, Chronic
Keywords:
Eligibility Criteria:	Click to view inclusion/exclusion criteria Inclusion Criteria: • Capable of understanding and willing to provide signed informed consent • Male or female at least 12 years of age at time of consent and at time of first dose. •Able to complete the study and to comply with study instructions. •Moderate to severe hand dermatitis. •Chronic hand dermatitis diagnosis must be at least 6 months Exclusion Criteria: •Female who is pregnant, trying to become pregnant, or breast feeding. •Currently diagnosed with allergic contact dermatitis. •Participated in a previous study of the same study product. •Had any major illness within 30 days before the screening/baseline visit. •Considered immunocompromised. •Has a clinically relevant history of or current evidence of abuse of alcohol or other drugs. •Considered unable or unlikely to attend the necessary visits.
Gender:	Both
Minimum Age:	12 Year
Maximum Age:
Enrollment:	125
Enrollment Type:	Actual
Healthy Volunteers?:	none
Central Contact:	Call Center
Central Contact Phone:	877-379-3718
Central Contact Email:	GSKClinicalSupportHD@gsk.com
Backup Central Contact:
Backup Central Contact Phone:
Backup Central Contact Email:
Overall Study Official:	GSK Clinical Trials
Overall Study Official Affiliation:	GlaxoSmithKline
Overall Study Official Role:	Study Director
Responsible Party Name/Official Title:	Cheri Hudson; Clinical Disclosure Advisor
Responsible Party Organization:	GSK Clinical Disclosure
Location and Contact Information:	Click to view location information United States (click to view all sites in United States) Florida (click to view) GSK Investigational Site Boynton Beach, Florida, 33437; COMPLETED; Contact: Joshua M Berlin, Principal Investigator, . GSK Investigational Site West Palm Beach, Florida, 33401; COMPLETED; Contact: Kenneth Beer, Principal Investigator, . Kentucky (click to view) GSK Investigational Site Louisville, Kentucky, 40217; COMPLETED; Contact: Leon Kircik, Principal Investigator, . GSK Investigational Site Louisville, Kentucky, 40202; COMPLETED; Contact: Joseph Fowler, Principal Investigator, . New Jersey (click to view) GSK Investigational Site Montclair, New Jersey, 07042; COMPLETED; Contact: Jeanine B Downie, Principal Investigator, . GSK Investigational Site Belleville, New Jersey, 07109; COMPLETED; Contact: Joseph S Eastern, Principal Investigator, . Tennessee (click to view) GSK Investigational Site Nashville, Tennessee, 37215; COMPLETED; Contact: Michael H Gold, Principal Investigator, . GSK Investigational Site Knoxville, Tennessee, 37922; COMPLETED; Contact: Kimberly Grande, Principal Investigator, . Texas (click to view) GSK Investigational Site Austin, Texas, 78759; COMPLETED; Contact: Michael Jarratt, Principal Investigator, .

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Protocol Summary for 115054