Topical PH-10 Aqueous Hydrogel and Photodynamic Therapy for Psoriasis
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1 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%)
Treatment plaque area 1: PH-10 with 544 nm LED light illumination.
Drug: PH-10 (rose bengal disodium 0.001%)
Treatment plaque area 2: PH-10 with ambient light illumination.
Drug: Control
No treatment control.
|
Outcome Measures
Primary Outcome Measures
- 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. [12 weeks]
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.
Secondary Outcome Measures
- Change in Pruritus of subject's treatment and control plaque areas using a self-assessment scale of 0-4. [12 weeks]
Pruritus was assessed on a scale ranging from 0 (no pruritus) to 4 (frequent, troublesome pruritus that interferes with sleep or other activities).
- 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]
Eligibility Criteria
Criteria
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).
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Fitzpatrick skin type I-VI.
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Ability to understand and sign the informed consent document.
Exclusion Criteria:
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Female subjects of childbearing potential who are pregnant, attempting to conceive, or nursing an infant.
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Subjects who have received PUVA or UVB light therapy or systemic antipsoriatic therapy within 4 weeks of study treatment (two weeks for methotrexate).
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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.
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Subjects who have received any photosensitizing or phototoxic drug within 4 weeks of study treatment.
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Subjects who have received any approved biologic drug therapy for psoriasis within 3 months or 5 half-lives of study treatment.
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Subjects who have participated in a clinical research study within 4 weeks of study treatment.
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Subjects with a history of porphyria, systemic lupus erythematosus or xeroderma pigmentosum.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mount Sinai School of Medicine | New York | New York | United States | 10029 |
Sponsors and Collaborators
- Provectus Pharmaceuticals
Investigators
- Principal Investigator: Amir Larian, MD, Icahn School of Medicine at Mount Sinai
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PH-10-PS-21