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Randomized Study of PH-10 for Psoriasis

Primary Purpose

Psoriasis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
PH-10 (0.002% Rose Bengal)
PH-10 (0.005% Rose Bengal)
PH-10 (0.01% Rose Bengal)
Vehicle
Sponsored by
Provectus Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis

Eligibility Criteria

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

Inclusion Criteria:

  • Men or women, age 18 or older.
  • Presence of mild to moderate plaque psoriasis on the trunk or extremities (excluding palms, soles, scalp, and facial or intertriginous areas).
  • Fitzpatrick skin type I-VI.
  • Written informed consent by the subject or legal guardian.

Exclusion Criteria:

  • Female subjects of childbearing potential who are pregnant, attempting to conceive, not using effective contraception, or who are nursing an infant.
  • Subjects who have received psoralen plus ultraviolet A (PUVA) therapy or systemic antipsoriatic therapy (immunosuppressants, cytostatics, corticosteroids) within 28 days of study initiation (two weeks for methotrexate).
  • Subjects who have received ultraviolet B (UVB) light therapy within 14 days of study initiation.
  • Subjects who have received topical antipsoriatic therapy (including corticosteroids, tar, anthralin or Vitamin D analogs) to the study plaque areas within 14 days of study initiation.
  • Subjects who have received agents posing a clinically significant risk of photosensitivity reaction within 5 half-lives of study initiation.
  • Subjects who have received any approved or investigational biologic drug therapy for psoriasis within 90 days or 5 half-lives of study initiation.
  • Subjects who have participated in a clinical research study within 28 days of study initiation.
  • Subjects with a history of porphyria, systemic lupus erythematosus or xeroderma pigmentosum.
  • Subjects with clinical conditions that, in the opinion of the 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

  • Dermatology Specialists, Inc.
  • International Dermatology Research
  • Mount Sinai School of Medicine
  • Wake Research Associates

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

PH-10 Treatment (High Dose Cohort)

PH-10 Treatment (Mid Dose Cohort)

PH-10 Treatment (Low Dose Cohort)

Vehicle Control

Arm Description

Outcomes

Primary Outcome Measures

The primary efficacy endpoint is "Treatment Success," a static endpoint assessed at Day 29 after initial PH-10 treatment and defined as 0 or 1 on all Psoriasis Severity Index (PSI) components and 0 or 1 on the Plaque Response scale.
The primary safety endpoint is incidence of adverse experiences, including pain and dermatologic/skin toxicity (incidence, severity, frequency, duration and causality).

Secondary Outcome Measures

Psoriasis Severity Index (PSI) score changes at each visit from Day 1 pre-treatment.
Plaque Response score changes at each visit from Day 1 pre-treatment.
Pruritus Self-Assessment score changes at each visit from Day 1 pre-treatment.

Full Information

First Posted
November 23, 2010
Last Updated
September 27, 2012
Sponsor
Provectus Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01247818
Brief Title
Randomized Study of PH-10 for Psoriasis
Official Title
A Phase 2 Dose-Randomized, Vehicle-Controlled Study of PH-10-Aqueous Hydrogel for the Treatment of Plaque Psoriasis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Provectus Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
PH-10 is an aqueous hydrogel formulation of rose bengal disodium (RB) for topical administration to the skin, and is being studied for the treatment of cutaneous skin disorders, specifically psoriasis and atopic dermatitis. This multicenter phase 2 study of subjects randomized sequentially by center to one of four treatment cohorts will assess efficacy and safety of topical PH-10 applied once daily to areas of mild to moderate plaque psoriasis.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
99 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PH-10 Treatment (High Dose Cohort)
Arm Type
Experimental
Arm Title
PH-10 Treatment (Mid Dose Cohort)
Arm Type
Experimental
Arm Title
PH-10 Treatment (Low Dose Cohort)
Arm Type
Experimental
Arm Title
Vehicle Control
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
PH-10 (0.002% Rose Bengal)
Intervention Description
PH-10 will be applied daily for 28 days to skin areas affected by mild to moderate psoriasis.
Intervention Type
Drug
Intervention Name(s)
PH-10 (0.005% Rose Bengal)
Intervention Description
PH-10 will be applied daily for 28 days to skin areas affected by mild to moderate psoriasis.
Intervention Type
Drug
Intervention Name(s)
PH-10 (0.01% Rose Bengal)
Intervention Description
PH-10 will be applied daily for 28 days to skin areas affected by mild to moderate psoriasis.
Intervention Type
Drug
Intervention Name(s)
Vehicle
Intervention Description
PH-10 vehicle will be applied daily for 28 days to skin areas affected by mild to moderate psoriasis.
Primary Outcome Measure Information:
Title
The primary efficacy endpoint is "Treatment Success," a static endpoint assessed at Day 29 after initial PH-10 treatment and defined as 0 or 1 on all Psoriasis Severity Index (PSI) components and 0 or 1 on the Plaque Response scale.
Time Frame
28 days
Title
The primary safety endpoint is incidence of adverse experiences, including pain and dermatologic/skin toxicity (incidence, severity, frequency, duration and causality).
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Psoriasis Severity Index (PSI) score changes at each visit from Day 1 pre-treatment.
Time Frame
8 weeks
Title
Plaque Response score changes at each visit from Day 1 pre-treatment.
Time Frame
8 weeks
Title
Pruritus Self-Assessment score changes at each visit from Day 1 pre-treatment.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men or women, age 18 or older. Presence of mild to moderate plaque psoriasis on the trunk or extremities (excluding palms, soles, scalp, and facial or intertriginous areas). Fitzpatrick skin type I-VI. Written informed consent by the subject or legal guardian. Exclusion Criteria: Female subjects of childbearing potential who are pregnant, attempting to conceive, not using effective contraception, or who are nursing an infant. Subjects who have received psoralen plus ultraviolet A (PUVA) therapy or systemic antipsoriatic therapy (immunosuppressants, cytostatics, corticosteroids) within 28 days of study initiation (two weeks for methotrexate). Subjects who have received ultraviolet B (UVB) light therapy within 14 days of study initiation. Subjects who have received topical antipsoriatic therapy (including corticosteroids, tar, anthralin or Vitamin D analogs) to the study plaque areas within 14 days of study initiation. Subjects who have received agents posing a clinically significant risk of photosensitivity reaction within 5 half-lives of study initiation. Subjects who have received any approved or investigational biologic drug therapy for psoriasis within 90 days or 5 half-lives of study initiation. Subjects who have participated in a clinical research study within 28 days of study initiation. Subjects with a history of porphyria, systemic lupus erythematosus or xeroderma pigmentosum. Subjects with clinical conditions that, in the opinion of the 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
Eric Wachter, Ph.D.
Organizational Affiliation
Provectus Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Dermatology Specialists, Inc.
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
International Dermatology Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
Mount Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Wake Research Associates
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27602
Country
United States

12. IPD Sharing Statement

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Randomized Study of PH-10 for Psoriasis

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