Topical PH-10 Aqueous Hydrogel and Photodynamic Therapy for Psoriasis

Study Overview
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Brief Summary
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This is an open label, single center, controlled study with each subject's two treatment plaque areas assigned by the investigator 1:1 to (a) PH-10 with ambient light exposure and (b) PH-10 with 544 nm LED light illumination at 10 J/cm2. A third plaque area will receive no treatment and serve as a control. Subjects with at least three distinct, stable study plaque areas will receive the experimental therapy to two treatment plaque areas twice a week (2-5 days apart) for the lesser of 12 weeks or until remission is observed in the treatment plaque areas. If remission is observed in a treatment plaque area then treatment of that area will be discontinued and the area assessed weekly. A third plaque area (control plaque area) will receive no drug or light treatment and serve as an internal control. Primary efficacy will be assessed 12 weeks after initial PH-10 treatment. Subjects will be followed for a total of 16 weeks to allow assessment of Durability of Response of treated lesions and comprehensive follow-up of adverse events.

Official Title
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A Phase 2 Study of Topical PH-10 Aqueous Hydrogel and Photodynamic Therapy for the Treatment of Plaque Psoriasis

Conditions
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Plaque Psoriasis

Intervention / Treatment
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* Drug: PH-10 (rose bengal disodium 0.001%)
* Drug: PH-10 (rose bengal disodium 0.001%)
* Drug: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Stable, moderate to severe plaque psoriasis in at least three distinct plaque areas, each separated by at least a 2.5-cm band of normal skin. Study plaque areas, each covering a contiguous area up to 15 x 35 cm in size, should have a minimum plaque size of 2 cm2. All study plaque areas must be on the trunk or extremities (excluding palms, soles, scalp, and facial or intertriginous sites). Fitzpatrick skin type I-VI. Ability to understand and sign the informed consent document. Exclusion Criteria: Female subjects of childbearing potential who are pregnant, attempting to conceive, or nursing an infant. Subjects who have received PUVA or UVB light therapy or systemic antipsoriatic therapy within 4 weeks of study treatment (two weeks for methotrexate). Subjects who have received topical antipsoriatic therapy (including corticosteroids, tar, anthralin, or Vitamin D analogs) to the study plaque areas within 2 weeks of study treatment. Subjects who have received any photosensitizing or phototoxic drug within 4 weeks of study treatment. Subjects who have received any approved biologic drug therapy for psoriasis within 3 months or 5 half-lives of study treatment. Subjects who have participated in a clinical research study within 4 weeks of study treatment. Subjects with a history of porphyria, systemic lupus erythematosus or xeroderma pigmentosum. Subjects with clinical conditions that, in the opinion of the Principal Investigator, may pose a health risk to the subject by being involved in the study or detrimentally affect regular follow-up of the subject.

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Each subject's study plaque areas will be assigned by the investigator to two PH-10 treatment plaque areas and one control plaque area. | Drug: PH-10 (rose bengal disodium 0.001%)<br>* Treatment plaque area 1: PH-10 with 544 nm LED light illumination.<br>Drug: PH-10 (rose bengal disodium 0.001%)<br>* Treatment plaque area 2: PH-10 with ambient light illumination.<br>Drug: Control<br>* No treatment control.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Success, defined as 0 or 1 on all Psoriasis Severity Index components (erythema, induration, and scaling) and 0 or 1 on the Plaque Response scale. | Treatment Success was assessed after 12 weeks and defined as 0 or 1 on all Psoriasis Severity Index components (erythema, induration, and scaling) and 0 or 1 on the Plaque Response scale. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pruritus of subject's treatment and control plaque areas using a self-assessment scale of 0-4. | Pruritus was assessed on a scale ranging from 0 (no pruritus) to 4 (frequent, troublesome pruritus that interferes with sleep or other activities). | 12 weeks | 
| Time to Remission (TTR) based on the (a) number of treatments and (b) days elapsed until Treatment Success is noted in each treatment plaque area. |  | 12 weeks | 
| Durability of Response based on plaque areas exhibiting Treatment Success that retain this level of response. |  | 16 weeks | 
| Adverse Experience. |  | 16 weeks |