Randomized Study of PH-10 for Psoriasis

A Phase 2 Dose-Randomized, Vehicle-Controlled Study of PH-10-Aqueous Hydrogel for the Treatment of Plaque Psoriasis

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.

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Drug: PH-10 (0.01% Rose Bengal); Drug: PH-10 (0.005% Rose Bengal); Drug: PH-10 (0.002% Rose Bengal); Drug: Vehicle

• Study Type: Interventional
• Enrollment (Actual): 99
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Oceanside, California, United States, 92056
      • Dermatology Specialists, Inc.
  • Florida
    • Miami, Florida, United States, 33144
      • International Dermatology Research
  • New York
    • New York, New York, United States, 10029
      • Mount Sinai School of Medicine
  • North Carolina
    • Raleigh, North Carolina, United States, 27602
      • Wake Research Associates

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Vehicle Control	Drug: Vehicle; PH-10 vehicle will be applied daily for 28 days to skin areas affected by mild to moderate psoriasis.
Experimental: PH-10 Treatment (High Dose Cohort)	Drug: PH-10 (0.01% Rose Bengal); PH-10 will be applied daily for 28 days to skin areas affected by mild to moderate psoriasis.
Experimental: PH-10 Treatment (Mid Dose Cohort)	Drug: PH-10 (0.005% Rose Bengal); PH-10 will be applied daily for 28 days to skin areas affected by mild to moderate psoriasis.
Experimental: PH-10 Treatment (Low Dose Cohort)	Drug: PH-10 (0.002% Rose Bengal); PH-10 will be applied daily for 28 days to skin areas affected by mild to moderate psoriasis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	28 days
The primary safety endpoint is incidence of adverse experiences, including pain and dermatologic/skin toxicity (incidence, severity, frequency, duration and causality).	8 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Psoriasis Severity Index (PSI) score changes at each visit from Day 1 pre-treatment.	8 weeks
Plaque Response score changes at each visit from Day 1 pre-treatment.	8 weeks
Pruritus Self-Assessment score changes at each visit from Day 1 pre-treatment.	8 weeks

Collaborators and Investigators

• Sponsor: Provectus Pharmaceuticals
• Investigators: Study Director: Eric Wachter, Ph.D., Provectus Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): August 1, 2011
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: November 23, 2010
• First Submitted That Met QC Criteria: November 23, 2010
• First Posted (Estimate): November 24, 2010

Study Record Updates

• Last Update Posted (Estimate): September 28, 2012
• Last Update Submitted That Met QC Criteria: September 27, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: PH-10-PS-23