Clinical trial NCT01323673: Ethanol-Free Clobetasol Propionate Foam 0.05% (Olux-E Foam) vs Vehicle Foam in the Treatment of Chronic Hand Dermatitis.
Official title: Ethanol-Free Clobetasol Propionate Foam 0.05% (Olux-E Foam) vs Vehicle Foam in the Treatment of Chronic Hand Dermatitis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dermatitis, Chronic
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
First posted: 2011-03-25
Enrollment: 125
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: 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
timeFrame: Baseline (Day 1) and Day 15
Secondary outcomes:
measure: Number of Participants With an Improvement of at Least 1 Grade in the ISGA (Target Hand) Score From Baseline to Day 15
timeFrame: Baseline (Day 1) and Day 15
measure: 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
timeFrame: Baseline (Day 1), Day 3, and Day 8
measure: 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
timeFrame: Baseline (Day 1), Day 3, and Day 8
measure: Number of Participants With an ISGA (Target Hand) Score of 0 or 1 at Days 3, 8, and 15
timeFrame: Days 3, 8, and 15
measure: 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
timeFrame: Baseline (Day 1) and Days 3, 8, and 15
measure: Number of Participants With an SGA (Target Hand) Score of 0 or 1 at Days 3, 8, and 15
timeFrame: Days 3, 8, and 15
measure: Percent Change From Baseline in Pruritus, Stinging, Burning, and Pain Scores (Target Hand) at Days 3, 8, and 15
timeFrame: Baseline (Day 1) and Days 3, 8, and 15
Other outcomes:
Locations:
city: San Diego
country: United States
facility: GSK Investigational Site
state: California
city: Boynton Beach
country: United States
facility: GSK Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: GSK Investigational Site
state: Florida
city: Louisville
country: United States
facility: GSK Investigational Site
state: Kentucky
city: Louisville
country: United States
facility: GSK Investigational Site
state: Kentucky
city: Belleville
country: United States
facility: GSK Investigational Site
state: New Jersey
city: Montclair
country: United States
facility: GSK Investigational Site
state: New Jersey
city: Knoxville
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Austin
country: United States
facility: GSK Investigational Site
state: Texas
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Kircik LH, Eastman WJ, Gwazdauskas J. A randomized, double-blind phase 4 study of the efficacy and safety of ethanol-free clobetasol propionate foam, 0.05%, vs vehicle foam in the treatment of chronic hand dermatitis. J Drugs Dermatol. 2013 Mar;12(3):328-34.