The Effect of Enstilar Versus Vehicle on Target Lesions in Moderate Plaque Type Psoriasis Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in Physicians Global Assessment (PGA) From Baseline to Week 2 and Week 4
研究概览
简要总结
This study seeks to show whether there is a benefit of prescribing Enstilar in the treatment of patients with moderate plaque type psoriasis. Subjects will receive study treatment of Enstilar foam.
详细描述
Approximately 20 subjects from 3 sites will be enrolled in this open-label study. Subjects will receive Enstilar foam and all adverse events and concomitant medications will be recorded.
Subjects will attend a screening visit/baseline visit and those with plaque-type psoriasis and bilateral symmetric psoriatic plaques will have a target lesion identified on knees or elbows and subjects will receive study treatment as outlined above.
Enstilar will be initiated daily for the entire study period of four weeks. Study visits will occur as follows: screening/baseline, week 2, week 4. Study assessments at each visit will be Body Surface Area (BSA,) Physicians Global Assessment (PGA,) Target lesion size, Total Lesion Severity Score (TLSS) and standard medical assessments. There will be standard medication/treatment and washout periods.
NOTE: The original study protocol dated december 20, 2017, was designed to compare the effect of Enstilar versus vehicle for the treatment of plaque psoriasis at a 1:1 ratio. A protocol amendment on March 20, 2018 eliminated the chance of placebo and made this an open-label study of the effects of Enstilar for the treatment of plaque psoriasis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Outpatient, male or female subjects of any race, 18 years of age or higher. Female subjects of childbearing potential must have a (-) urine pregnancy test (UPT) result within 7 days of the first dose of study drug and practice a reliable method of contraception throughout the study.
- •A female is considered of childbearing potential unless she is:
- •postmenopausal >5 years, without a uterus and/or both ovaries, or has been surgically sterile for >6 months
- •Reliable methods of contraception are:
- •hormonal methods or intrauterine device (IUD) in use > 90 days prior to study drug administration, barrier methods plus spermicide in use > 14 days prior, or vasectomized partner.
- •[Exception: Female subjects of child bearing potential (CBP) who are not sexually active are not required to practice a reliable method of contraception and may be enrolled at the Investigator's discretion provided they are counselled to remain sexually inactive for the duration of the study and understand the risks involved in getting pregnant during the study.]
- •Moderate plaque type psoriasis eligible for topical therapies.
- •Patients with a minimum of 3% BSA to a maximum of 20% BSA & bilateral symmetric psoriatic plaques of 2 to 4 cm in diameter.
- •Physician Global Assessment (PGA) score of
- •Able to understand study requirements and sign Informed Consent/HIPAA forms.
排除标准
- •Female subjects who are pregnant, breast-feeding, or who are of childbearing potential and not practicing a reliable method of birth control, or male subjects planning a pregnancy with their spouse or partner while in the study.
- •History of hypercalcaemia or vitamin D toxicity.
- •Patients with guttate, erythrodermic, or pustular psoriasis
- •Serious skin condition (other than psoriasis) or uncontrolled medical condition (in the opinion of the investigator.)
- •Topical steroids, topical immunomodulators, topical vitamin D derivatives, tar, salicylic acid, anthralin or any other topical treatment for psoriasis within 2 weeks of baseline.
- •Use of any biologics within 3 months of baseline.
- •Use of other systemic psoriasis treatments (ie, oral retinoids, methotrexate, cyclosporine, or other immunomodulators) within 4 weeks of baseline.
- •Use of ultraviolet B rays (UVB) or psoralen+ultraviolet a rays (PUVA) within 2 weeks of baseline.
- •Skin conditions (e.g. eczema) other than psoriasis that may interfere with evaluations of psoriasis.
- •Known hypersensitivity to Enstilar or any of its components.
- •Contraindications according to Enstilar.
- •Current drug or alcohol abuse (Investigator opinion.)
- •Subject unable to commit to all the assessments required by protocol. -
研究组 & 干预措施
Enstilar foam
Subjects will receive calcipotriene hydrate/betamethasone dipropionate (Enstilar) foam and apply to affected areas once daily. A target lesion located on elbow or knee will be identified by the Investigator for daily treatment with the medicated foam from Baseline through week 4.
干预措施: Enstilar (Drug)
结局指标
主要结局
Change in Physicians Global Assessment (PGA) From Baseline to Week 2 and Week 4
时间窗: screening/baseline, week 2, week 4
Physician assessment of disease severity. 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate
次要结局
- Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Induration(screening/baseline, week 2, week 4)
- Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Erythema(screening/baseline, week 2, week 4)
- Change in Lesion Size From Baseline to Week 2 and Week 4(screening/baseline, week 2, week 4)
- Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Scaling(screening/baseline, week 2, week 4)
- Change in Body Surface Area (BSA) From Baseline to Week 2 and Week 4(screening/baseline, week 2, week 4)