Ethanol-Free Clobetasol Propionate Foam 0.05% (Olux-E Foam) vs Vehicle Foam in the Treatment of Chronic Hand Dermatitis.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
The purpose of this study is to determine how clobetasol proprionate foam works against a placebo foam in the treatment of hand dermatitis.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Clobetasol Propionate 0.05%
干预措施: clobetasol propionate 0.05% (Drug)
Vehicle
干预措施: Vehicle / Placebo (Drug)
结局指标
主要结局
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
时间窗: Baseline (Day 1) and 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.
次要结局
- Number of Participants With an ISGA (Target Hand) Score of 0 or 1 at Days 3, 8, and 15(Days 3, 8, and 15)
- Number of Participants With an Improvement of at Least 1 Grade in the ISGA (Target Hand) Score From Baseline to Day 15(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(Baseline (Day 1), Day 3, and Day 8)
- Number of Participants With an SGA (Target Hand) Score of 0 or 1 at Days 3, 8, and 15(Days 3, 8, and 15)
- 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(Baseline (Day 1), Day 3, and Day 8)
- 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(Baseline (Day 1) and Days 3, 8, and 15)
- Percent Change From Baseline in Pruritus, Stinging, Burning, and Pain Scores (Target Hand) at Days 3, 8, and 15(Baseline (Day 1) and Days 3, 8, and 15)