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Topical PH-10 Aqueous Hydrogel and Photodynamic Therapy for Psoriasis

Primary Purpose

Plaque Psoriasis

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

PH-10 (rose bengal disodium 0.001%)

Control

About this trial

This is an interventional treatment trial for Plaque Psoriasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Mount Sinai School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

Each subject's study plaque areas will be assigned by the investigator to two PH-10 treatment plaque areas and one control plaque area.

Outcomes

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.

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 Outcome Measures

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

Pruritus was assessed on a scale ranging from 0 (no pruritus) to 4 (frequent, troublesome pruritus that interferes with sleep or other activities).

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.

Durability of Response based on plaque areas exhibiting Treatment Success that retain this level of response.

Adverse Experience.

Full Information

NCT ID

NCT00555646

First Posted

November 7, 2007

Last Updated

December 1, 2021

Sponsor

Provectus Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00555646

Brief Title

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

2. Study Status

Record Verification Date

December 2021

Overall Recruitment Status

Terminated

Why Stopped

Change of dose regimen (new protocol)

Study Start Date

November 2007 (undefined)

Primary Completion Date

September 2008 (Actual)

Study Completion Date

September 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Provectus Pharmaceuticals

4. Oversight

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Plaque Psoriasis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Each subject's study plaque areas will be assigned by the investigator to two PH-10 treatment plaque areas and one control plaque area.

Intervention Type

Drug

Intervention Name(s)

PH-10 (rose bengal disodium 0.001%)

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

PH-10 (rose bengal disodium 0.001%)

Intervention Description

Treatment plaque area 2: PH-10 with ambient light illumination.

Intervention Type

Drug

Intervention Name(s)

Control

Intervention Description

No treatment control.

Primary Outcome Measure Information:

Title

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.

Description

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.

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

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

Description

Pruritus was assessed on a scale ranging from 0 (no pruritus) to 4 (frequent, troublesome pruritus that interferes with sleep or other activities).

Time Frame

12 weeks

Title

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

Title

Durability of Response based on plaque areas exhibiting Treatment Success that retain this level of response.

Time Frame

16 weeks

Title

Adverse Experience.

Time Frame

16 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Amir Larian, MD

Organizational Affiliation

Icahn School of Medicine at Mount Sinai

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mount Sinai School of Medicine

City

New York

State/Province

New York

ZIP/Postal Code

10029

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Topical PH-10 Aqueous Hydrogel and Photodynamic Therapy for Psoriasis

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