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
1 other identifier
interventional
99
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Dec 2010
Shorter than P25 for phase_2
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 23, 2010
CompletedFirst Posted
Study publicly available on registry
November 24, 2010
CompletedStudy Start
First participant enrolled
December 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedSeptember 28, 2012
September 1, 2012
8 months
November 23, 2010
September 27, 2012
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (3)
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
Study Arms (4)
PH-10 Treatment (High Dose Cohort)
EXPERIMENTALPH-10 Treatment (Mid Dose Cohort)
EXPERIMENTALPH-10 Treatment (Low Dose Cohort)
EXPERIMENTALVehicle Control
PLACEBO COMPARATORInterventions
PH-10 will be applied daily for 28 days to skin areas affected by mild to moderate psoriasis.
PH-10 will be applied daily for 28 days to skin areas affected by mild to moderate psoriasis.
PH-10 will be applied daily for 28 days to skin areas affected by mild to moderate psoriasis.
PH-10 vehicle will be applied daily for 28 days to skin areas affected by mild to moderate psoriasis.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Dermatology Specialists, Inc.
Oceanside, California, 92056, United States
International Dermatology Research
Miami, Florida, 33144, United States
Mount Sinai School of Medicine
New York, New York, 10029, United States
Wake Research Associates
Raleigh, North Carolina, 27602, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Eric Wachter, Ph.D.
Provectus Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 23, 2010
First Posted
November 24, 2010
Study Start
December 1, 2010
Primary Completion
August 1, 2011
Study Completion
March 1, 2012
Last Updated
September 28, 2012
Record last verified: 2012-09