The purpose of this study is to determine how clobetasol proprionate foam works against a placebo foam in the treatment of hand dermatitis.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
125
2 times a day, 14 total days study treatment
2 times a day, 14 total days of study treatment
GSK Investigational Site
San Diego, California, United States
GSK Investigational Site
Boynton Beach, Florida, United States
GSK Investigational Site
West Palm Beach, Florida, United States
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
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
Number of Participants With an Improvement of at Least 1 Grade in the ISGA (Target Hand) Score From Baseline to Day 15
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
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
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.
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GSK Investigational Site
Louisville, Kentucky, United States
GSK Investigational Site
Louisville, Kentucky, United States
GSK Investigational Site
Belleville, New Jersey, United States
GSK Investigational Site
Montclair, New Jersey, United States
GSK Investigational Site
Knoxville, Tennessee, United States
GSK Investigational Site
Nashville, Tennessee, United States
GSK Investigational Site
Austin, Texas, United States
Time frame: Baseline (Day 1), Day 3, and Day 8
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
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
Number of Participants With an ISGA (Target Hand) Score of 0 or 1 at Days 3, 8, and 15
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
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
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
Number of Participants With an SGA (Target Hand) Score of 0 or 1 at Days 3, 8, and 15
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
Percent Change From Baseline in Pruritus, Stinging, Burning, and Pain Scores (Target Hand) at Days 3, 8, and 15
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