Clinical trial NCT00555646: Topical PH-10 Aqueous Hydrogel and Photodynamic Therapy for Psoriasis
Official title: A Phase 2 Study of Topical PH-10 Aqueous Hydrogel and Photodynamic Therapy for the Treatment of Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Plaque Psoriasis
Lead sponsor: Provectus Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2007-11-09
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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).
* 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.

Primary outcomes:
measure: 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.
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in Pruritus of subject's treatment and control plaque areas using a self-assessment scale of 0-4.
timeFrame: 12 weeks
measure: 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.
timeFrame: 12 weeks
measure: Durability of Response based on plaque areas exhibiting Treatment Success that retain this level of response.
timeFrame: 16 weeks
measure: Adverse Experience.
timeFrame: 16 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Amir Larian, MD
role: PRINCIPAL_INVESTIGATOR
References: