Topical PH-10 Aqueous Hydrogel and Photodynamic Therapy for Psoriasis - Full Text View

Purpose

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

MedlinePlus related topics:

Psoriasis Rashes

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment

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

Further study details as provided by Provectus Pharmaceuticals:

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. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in Pruritus of subject's treatment and control plaque areas using a self-assessment scale of 0-4. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Durability of Response based on plaque areas exhibiting Treatment Success that retain this level of response. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Adverse Experience. [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	25
Study Start Date:	November 2007
Estimated Study Completion Date:	August 2008
Estimated Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00555646

Contacts


Contact: Giselle Singer	(212) 241-3288	Giselle.Singer@mssm.edu

Locations


United States, New York
	Mount Sinai School of Medicine	Recruiting
	New York, New York, United States, 10029
	Principal Investigator: Amir Larian, MD

Sponsors and Collaborators

Provectus Pharmaceuticals

Investigators


Principal Investigator:	Amir Larian, MD	Mount Sinai School of Medicine

More Information

Responsible Party:	Provectus Pharmaceuticals, Inc. ( Eric Wachter, Ph.D./Vice President )
Study ID Numbers:	PH-10-PS-21
First Received:	November 7, 2007
Last Updated:	March 21, 2008
ClinicalTrials.gov Identifier:	NCT00555646
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Skin Diseases

Psoriasis

Connective Tissue Diseases

Skin Diseases, Papulosquamous

Additional relevant MeSH terms:

Skin and Connective Tissue Diseases

ClinicalTrials.gov processed this record on May 15, 2008

Sponsored by:	Provectus Pharmaceuticals
Information provided by:	Provectus Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00555646