A Double-blinded, Placebo-controlled Study to Evaluate the Tolerability and Efficacy of Enstilar® (Calcipotriene and Betamethasone Dipropionate) Foam in the Treatment of Chronic Plaque Psoriasis in Patients With Skin of Color
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Number of Patients Who Achieved Treatment Success
研究概览
简要总结
This will be a single-center, randomized, double-blinded, vehicle-controlled clinical study to determine the efficacy of Enstilar® foam, a combination of calcipotriene and betamethasone dipropionate 0.005%/0.064%, in the treatment of psoriasis vulgaris in skin of color (FST IV-VI). This study will also evaluate the degree of erythema versus hyperpigmentation in psoriasis plaques in skin of color (and its change with Enstilar ® treatment) as well as the effect of Enstilar ® on post-inflammatory hyperpigmentation and quality of life.
详细描述
Psoriasis is a chronic inflammatory disorder primarily affecting the skin and joints. This condition occurs in different ethnic groups worldwide with varying prevalence.
There are notable differences in psoriasis presentation in skin of color groups. Black patients with psoriasis tend to have less erythema, increased risk of pigmentation, thicker plaques, more scaling, and greater body involvement as compared to white patients. The resolution of psoriasis lesions in darker skin types is associated with a higher rate of dyspigmentation (both hyper- and hypo-pigmentation), which may be more bothersome to patients than the psoriasis itself. Further, several studies have shown that psoriasis is associated with greater psychological impact and worse quality of life in non-whites with psoriasis compared to whites.
Unique issues in skin of color populations make studies dedicated to darker skin types essential for the treatment of psoriasis in these populations. This study will evaluate the efficacy of Enstilar® foam, a combination of calcipotriene and betamethasone dipropionate 0.005%/0.064%, in the treatment of psoriasis vulgaris in darker skin types. This study will also evaluate the degree of erythema versus hyperpigmentation in psoriasis plaques as well as the effect of Enstilar ® on post-inflammatory hyperpigmentation and quality of life in skin of color.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double-blind, vehicle-controlled from week 0 to 4
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provide written, signed and dated informed consent prior to initiating any study-related activities.
- •Male or female >18 years of age at the time of screening
- •Fitzpatrick Skin phototype IV-VI, non-white race/ethnicity, including but not limited to - --African Americans, Asians, Pacific Islanders and Hispanics.
- •Clinical diagnosis of chronic plaque-type psoriasis of the body
- •Plaque psoriasis with ≥2% Body Surface Area (BSA) involvement (may include scalp involvement), PASI Score ≥ 2, IGA mod 2011 score of 2 or greater (based on scale of 0-4)
- •Females of childbearing potential (FCBP) must have a negative pregnancy test at Screening and Baseline. While using investigational product and for at least 28 days after last application of investigational product, FCBP who engage in activity in which conception is possible must use one of the approved contraceptive options d
- •Must be in general good health as judged by the Investigator, based on medical history and physical examination.
排除标准
- •Form of diagnosed psoriasis other than chronic plaque psoriasis (i.e. guttate, erythrodermic, pustular)
- •Diagnosis of other active, ongoing skin diseases or skin infections that may interfere with examination of psoriasis lesions
- •Ongoing use of other psoriasis treatment including but not limited to topical or systemic corticosteroids, other topical medications (i.e. coal tar), oral or biologic medications for the treatment of psoriasis, and UV therapy. The following washout periods will be required: 2 weeks for topical therapy; 2 weeks for phototherapy; 12 weeks for biologic or targeted therapies; 4 weeks for other systemic therapies
- •Use of oral estrogen therapy, excluding oral contraceptive pills
- •Women who are pregnant, nursing, or of child-bearing potential who are unwilling to use appropriate method(s) of contraception.
- •Patients unwilling to limit exposure to UV light
- •Current significant medical problems that, in the discretion of the investigator, would put the patient at significant risk
- •Patients with disorders of calcium metabolism and/or hypercalcemia
- •Use of any investigational drug within 4 weeks prior to randomization, or 5 pharmacokinetic/pharmacodynamics half-lives, if known (whichever is longer)
- •History of allergy to any component of the IP
研究组 & 干预措施
Vehicle foam
does not contain the active ingredient
干预措施: Vehicle foam (Drug)
Enstilar® foam
Enstilar® foam - a combination of calcipotriene and betamethasone dipropionate 0.005%/0.064%.
干预措施: Enstilar® foam (Drug)
结局指标
主要结局
Number of Patients Who Achieved Treatment Success
时间窗: Week 4
Number of patients at week 4 who achieved treatment success according to Investigator's Global Assessment (IGA mod 2011) of the entire body including scalp. IGA ranges from 0 (clear) to 4 (severe). Treatment success is defined as IGA of clear (0) or almost clear (1) for patients with ≥ moderate disease at baseline or IGA of clear (0) for patients with mild disease at baseline.
次要结局
- Number of Participants With Achieving Targeted Psoriasis Area and Severity Index (PASI)(4 weeks, 8 weeks)
- Number of Patients Achieving Targeted Psoriasis Scalp Severity Index (PSSI)(2 weeks, 4 weeks, 8 weeks)
- Number of Patients With Treatment Success According to Investigator Global Assessment (IGA Mod 2011)(at week 8)
- Number of Participants Who Achieved Treatment Success According to Scalp Investigator Global Assessment (ScIGA)(4 weeks, 8 weeks)
- Patient's Global Assessment of Itch(Baseline, 2 weeks, 4 weeks, 8 weeks)
- Number of Participants Who Clear or Almost Clear Disease According to the Patient's Global Assessment of Disease Severity (PaGA)(4 weeks, 8 weeks)
- Erythema Indices of Target Psoriasis Plaque(Baseline, 2 weeks, 4 weeks, 8 weeks)
- Melanin Indices of Target Psoriasis Plaque(Baseline, 2 weeks, 4 weeks, 8 weeks)
- Physician Dyspigmentation Visual Analog Scale (VAS)(baseline, 4 weeks, 8 weeks)
- Mean Change in Dermatology Life Quality Index (DLQI)(Baseline, 2 weeks, 4 weeks, 8 weeks)
研究者
Andrew Alexis, MD
Chair, Department of Dermatology
Icahn School of Medicine at Mount Sinai