A Comparison of Treatment of Psoriasis With Acitretin or Tazarotene Gel 0.1% and Active or Sham Treatments With the 308 nm Excimer Laser
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Change in the NPF Psoriasis Score of Plaques
研究概览
简要总结
This is a randomized, double-blind study of excimer (308-nm UVB) laser added to either tazarotene 0.1% gel or acitretin 25 mg daily for plaque psoriasis.
The primary objective of this study is to compare the improvement of psoriatic plaques with and without excimer laser (308-nm UVB) treatment, applied in a randomized and blinded fashion, in subjects on acitretin 25 mg or tazarotene gel 0.1% QD.
详细描述
The hypothesis of this study is that excimer (308-nm UVB) laser added to either tazarotene 0.1% gel or acitretin 25 mg daily will lead to improved efficacy of these treatments alone.
The primary objective of this study is to compare the improvement of psoriatic plaques with and without excimer laser (308-nm UVB) treatment, applied in a randomized and blinded fashion, in subjects on acitretin 25 mg or tazarotene gel 0.1% QD. The primary endpoint will be the comparison between the change in NPF score of plaques treated with excimer laser and those treated with sham treatment.
The secondary objectives are to compare the number of excimer light treatments and time necessary to achieve an average lesion assessment score of 0 to 1 in subjects treated with acitretin 25 mg PO or tazarotene gel 0.1% QD, and to evaluate adverse events related to combinations of the study treatments.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Excimer laser active and comparator were delivered the same way by a non-blinded person who applies a cap to the laser head to block UV rays for a sham administration. The masking was done by blindfolding the patients so they could not see which side was treated with active or sham laser. The outcomes assessor did their assessment in a separate room and access restricted to the randomization assignments.
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
- •Must give written informed consent
- •Must be at least 18 years old
- •Must have been diagnosed with stable plaque type psoriasis covering between 1 and 5% BSA
- •NPF-PS ≥8 (based additive scores averaged over all lesions for erythema, scale, and thickness range of score = 0-5)
- •No systemic or phototherapy in the 4 wks prior to entering the study
- •No topical therapy other than emollients (no corticosteroids, vitamin D analogs, vitamin A analogs) in the 2 wks prior to entering the study
- •Women on tazarotene gel must not be pregnant nor planning to become pregnant during the study and must be on two forms of birth control
- •Subjects known to not tolerate oral acitretin at 25 mg/day and women of child-bearing potential may be enrolled and treated with topical tazarotene gel 0.1%
排除标准
- •Candidates will be excluded from study entry if any of the following exclusion criteria exist at the time of enrollment:
- •Unstable disease
- •Only treatable sites are in intertriginous areas or on face
- •Subjects unable to tolerate frequency of visits
- •NPF-PS severity score <8 additive score of erythema, scale, and thickness, averaged over all lesions
- •History of inability to tolerate topical tazarotene 0.1% gel and or acitretin 25 mg/day
- •Women of childbearing potential are excluded from the actretin arm of the study.
研究组 & 干预措施
acitretin and active excimer laser
patients enrolled in the acitretin arm will be treated with acitretin 25 mg daily and excimer (active) to randomly assigned left or right side of body psoriasis lesions.
干预措施: Acitretin 25Mg Oral Capsule (Drug)
acitretin and active excimer laser
patients enrolled in the acitretin arm will be treated with acitretin 25 mg daily and excimer (active) to randomly assigned left or right side of body psoriasis lesions.
干预措施: Excimer laser (Device)
acitretin and sham excimer laser
Patients in this arm were treated with acitretin 25 mg daily and sham (placebo) excimer laser to randomly assigned left or right side of body psoriasis lesions.
干预措施: Acitretin 25Mg Oral Capsule (Drug)
acitretin and sham excimer laser
Patients in this arm were treated with acitretin 25 mg daily and sham (placebo) excimer laser to randomly assigned left or right side of body psoriasis lesions.
干预措施: Sham excimer laser (Device)
tazarotene and active excimer laser
patients enrolled in this arm were treated with tazarotene 0.1% gel topical application daily and excimer (active) laser to randomly assigned left or right side of body psoriasis lesions.
干预措施: Excimer laser (Device)
tazarotene and active excimer laser
patients enrolled in this arm were treated with tazarotene 0.1% gel topical application daily and excimer (active) laser to randomly assigned left or right side of body psoriasis lesions.
干预措施: Tazarotene 0.1% Gel,Top (Drug)
tazarotene and sham excimer laser
patients enrolled in this arm were treated with tazarotene 0.1% gel topical application daily and sham excimer laser to randomly assigned left or right side of body psoriasis lesions.
干预措施: Tazarotene 0.1% Gel,Top (Drug)
tazarotene and sham excimer laser
patients enrolled in this arm were treated with tazarotene 0.1% gel topical application daily and sham excimer laser to randomly assigned left or right side of body psoriasis lesions.
干预措施: Sham excimer laser (Device)
结局指标
主要结局
Change in the NPF Psoriasis Score of Plaques
时间窗: week 8
mean % change in the National Psoriasis Foundation (NPF) psoriasis score of the target plaques \[higher percent change in NPF score is consistent with improvement, while higher absolute NPF score is consistent with worse disease, minimum score of 0 (no disease) and maximum score of 30 (worst disease)\]
次要结局
- Number of Participants With Adverse Events(12 weeks)
- Number of Patients That Achieved an Average Lesion Assessment Score of 0 or 1 at Week 12.(8 weeks)
研究者
Kristina Callis
Assistant Professor
University of Utah