Topical PH-10 Aqueous Hydrogel and Photodynamic Therapy for Psoriasis

NCT00555646 | Terminated Phase 2

• 1 other identifier: PH-10-PS-21
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Plaque Psoriasis

Outcome Measures

Primary Outcomes (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.

  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.

  12 weeks

Secondary Outcomes (4)

• Change in Pruritus of subject's treatment and control plaque areas using a self-assessment scale of 0-4.

  12 weeks

• 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

Study Arms (1)

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%); Drug: Control

Interventions

PH-10 (rose bengal disodium 0.001%) DRUG

Treatment plaque area 1: PH-10 with 544 nm LED light illumination.

1

Control DRUG

No treatment control.

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Provectus Pharmaceuticals: lead

Study Sites (1)

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

Study Officials

• Amir Larian, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2007
• First Posted: November 9, 2007
• Study Start: November 1, 2007
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: December 16, 2021

Record last verified: 2021-12

Locations

US (1)