Taclonex Ointment With Hydrogel Patch Occlusion for the Treatment of Psoriasis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Plaque Psoriasis, Psoriasis Vulgaris

Intervention / Treatment
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* Drug: Taclonex Ointment and Hydrogel Patch
* Drug: Taclonex Ointment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Taclonex Ointment/Hydrogel Patch Applied Topically Once Daily<br>Taclonex ointment once daily used to treat one psoriatic plaque, along with the Hydrogel Patch used once daily. | Drug: Taclonex Ointment and Hydrogel Patch<br>* Each patient will have bilateral symmetrical psoriatic plaques. One plaque will be treated with Taclonex Ointment daily along with Hydrogel Patch daily. All treatment will be for 4 weeks.<br>|
| Active Comparator: Taclonex Ointment Topically Once Daily<br> | Drug: Taclonex Ointment<br>* Taclonex ointment daily for one psoriatic plaque.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Total Modified PASI Score at Week 4 Compared to Baseline | 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. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psoriasis, Plaque psoriasis, with bilateral symmetrical lesions., 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.