Plaque Psoriasis
Conditions
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.
Interventions
DRUGPH-10 (rose bengal disodium 0.001%)
Treatment plaque area 1: PH-10 with 544 nm LED light illumination.
DRUGControl
No treatment control.
Sponsors
Provectus Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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). |
Countries
United States
Outcome results
None listed