An Open-Label, Bilaterally-Controlled Single Center Study to Compare the Efficacy of Taclonex Ointment With Hydrogel Patch Occlusion to Taclonex Ointment Without Occlusion in the Treatment of Plaque-Type Psoriasis
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Change in Total Modified PASI Score at Week 4 Compared to Baseline
研究概览
简要总结
The purpose of this study is to determine whether using Taclonex ointment under a hydrogel patch is more effective than using the ointment alone in treating psoriasis. Taclonex ointment is currently FDA approved for use on psoriasis. The hydrogel patch is a type of adhesive pad and contains no medications. It is currently FDA approved and has been shown to be safe and virtually free of side effects. The hypothesis is that psoriatic plaques which are treated with Taclonex ointment under a hydrogel patch will be more effectively treated compared to psoriatic plaques treated with Taclonex alone.
详细描述
This will be an open label, bilaterally-controlled single center study. Thirty subjects with plaque type psoriasis will be enrolled in the study. All subjects will receive treatment on two target lesions that are similar in erythema, scaling and induration, and symmetric in anatomic location. The severity of their target lesions will be assessed using a modified Psoriasis Area and Severity Index (PASI) scoring system (Appendix A). Symmetrical target lesions must each be rated at a PASI score equal to or greater than 7 and be within 1 PASI score of each other.
All subjects will apply Taclonex ointment to both target lesions once daily for 4 weeks. The occlusive dressing will be applied by the subject to one of the two symmetrical target lesions once daily for 4 weeks. The occlusive dressing will be removed by the patient if he/she experiences warmth, irritation, increased erythema, and/or itching. If the patch is removed due to these symptoms and signs, the subject will leave the lesion un-occluded until for 24 hours, at which time a new occlusive dressing will be placed.
After the initial 4 weeks of treatment, there will be a follow up period of 6 weeks during which no treatment is used.
Subjects will be restricted from using systemic therapies for psoriasis during this study, including Psoralen Ultraviolet A (PUVA) photochemotherapy and herbal therapies. All topical medications, except the study medications, and UVB phototherapy are prohibited on the target lesions. All of the other psoriasis lesions on the body can be treated as usual with other topical medications and Ultraviolet B (UVB) phototherapy as long as it does not impact on the two target lesions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- 否
入选标准
- •Subject has signed the informed consent form and Health Information Portability and Accountability Act (HIPAA) authorization form;
- •Male or female subject at least 18 years of age;
- •A diagnosis of stable plaque-type psoriasis vulgaris with at least one pair of symmetric lesions on either the trunk, arms, or legs that would serve as target lesions. Paired target lesions must be in similar anatomic locations (e.g., right and left elbows or right and left knees) and have roughly equivalent (no more than one point difference) modified Psoriasis Area Severity Index (PASI) scores. Each paired target lesions must have PASI scores equal to or greater than 7;
- •Any additional diagnoses must, in the investigator's opinion, not preclude the subject from safely participating in this study or interfere with the evaluation of the subject's psoriasis;
- •Psoriasis must be clinically stable for at least 30 days before enrollment;
- •Subject is able to discontinue the use of any medication or therapy for relief of psoriasis in the target areas to be treated;
- •Subject is able to discontinue the use of any systemic medication or therapy (e.g. oral or injectable psoriasis medications, PUVA photochemotherapy, herbal remedies, etc.) for psoriasis;
- •Subject must be reliable and mentally competent to complete study measurements;
- •Subject is able to understand and agrees to comply with study requirements, attend study visits, and comply with the restrictions during the study.
排除标准
- •Subject has a skin disorder other than psoriasis in the target areas to be evaluated;
- •Known hypersensitivity to any component of the test medications;
- •Pigmentation, extensive scarring, or pigmented lesions in affected areas that would interfere with evaluation of efficacy parameters;
- •Clinically infected psoriasis at baseline;
- •Guttate, pustular, erythrodermic, or other non-plaque forms of psoriasis;
- •Spontaneously worsening or improving psoriasis within 30 days of enrollment;
- •Any evidence of atrophy in the areas selected for treatment with topical corticosteroid;
- •Topical or intralesional therapies (other than emollients) or UVB phototherapy on potential target lesions within two weeks of starting study treatment;
- •Systemic therapy, PUVA phototherapy, or a systemic investigational therapy for psoriasis within 30 days prior to study entry;
- •Treatment with topical investigational therapy of the target lesions within 30 days prior to study entry;
- •Subject is considered unreliable as to medication compliance or adherence to scheduled appointments as determined by the investigators.
- •Subject is pregnant
研究组 & 干预措施
Taclonex Ointment/Hydrogel Patch Applied Topically Once Daily
Taclonex ointment once daily used to treat one psoriatic plaque, along with the Hydrogel Patch used once daily.
干预措施: Taclonex Ointment and Hydrogel Patch (Drug)
Taclonex Ointment Topically Once Daily
干预措施: Taclonex Ointment (Drug)
结局指标
主要结局
Change in Total Modified PASI Score at Week 4 Compared to Baseline
时间窗: 4 weeks
Modified psoriasis severity index measures erythema, induration, and scaling each measured from 0-4, with a maximum summed score of 12. A higher score means greater psoriasis severity and a lower score means lower psoriasis severity.
次要结局
- Change in Modified PASI Scores Between Week 4 and Week 6 During the Follow-up Period. This is to Determine Whether There is Further Improvement of Psoriasis After the Cessation of Occlusion(6 Weeks)