Topical PH-10 Aqueous Hydrogel and Photodynamic Therapy for Psoriasis

• ClinicalTrials.gov Identifier: NCT00555646
• Recruitment Status: Terminated
• First Posted: November 9, 2007
• Last Update Posted: July 9, 2009
• Sponsor: Provectus Pharmaceuticals
• Information provided by: Provectus Pharmaceuticals

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
Plaque Psoriasis	Drug: PH-10 (rose bengal disodium 0.001%); Drug: Control	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 25 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 2 Study of Topical PH-10 Aqueous Hydrogel and Photodynamic Therapy for the Treatment of Plaque Psoriasis
• Study Start Date: November 2007
• Actual Primary Completion Date: June 2009
• Estimated Study Completion Date: July 2009

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%); PH-10 with 544 nm LED light illumination OR PH-10 with ambient light exposure; Drug: Control; No treatment control.

Outcome Measures

Primary Outcome Measures :

1. 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. [ Time Frame: 12 weeks ]

Secondary Outcome Measures :

1. Change in Pruritus of subject's treatment and control plaque areas using a self-assessment scale of 0-4. [ Time Frame: 12 weeks ]
2. 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. [ Time Frame: 12 weeks ]
3. Durability of Response based on plaque areas exhibiting Treatment Success that retain this level of response. [ Time Frame: 16 weeks ]
4. Adverse Experience. [ Time Frame: 16 weeks ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, New York

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

More Information

• Responsible Party: Eric Wachter, Ph.D./Vice President, Provectus Pharmaceuticals, Inc.
• ClinicalTrials.gov Identifier: NCT00555646
• Other Study ID Numbers: PH-10-PS-21
• First Posted: November 9, 2007
• Last Update Posted: July 9, 2009
• Last Verified: July 2009

Additional relevant MeSH terms:

Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases