Randomized Study of PH-10 for Psoriasis - Full Text View

Purpose

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.

Condition	Intervention	Phase
Psoriasis	Drug: PH-10 (0.002% Rose Bengal) Drug: PH-10 (0.005% Rose Bengal) Drug: PH-10 (0.01% Rose Bengal) Drug: Vehicle	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Phase 2 Dose-Randomized, Vehicle-Controlled Study of PH-10-Aqueous Hydrogel for the Treatment of Plaque Psoriasis

Resource links provided by NLM:

MedlinePlus related topics: Psoriasis

Drug Information available for: Rose Bengal

U.S. FDA Resources

Further study details as provided by Provectus Pharmaceuticals:

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. [ Time Frame: 28 days ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Psoriasis Severity Index (PSI) score changes at each visit from Day 1 pre-treatment. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Plaque Response score changes at each visit from Day 1 pre-treatment. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Pruritus Self-Assessment score changes at each visit from Day 1 pre-treatment. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment:	99
Study Start Date:	December 2010
Study Completion Date:	March 2012
Primary Completion Date:	August 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.
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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01247818

Locations

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

Sponsors and Collaborators

Provectus Pharmaceuticals

Investigators

Study Director:

Eric Wachter, Ph.D.

Provectus Pharmaceuticals

More Information

No publications provided

Responsible Party:	Provectus Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT01247818 History of Changes
Other Study ID Numbers:	PH-10-PS-23
Study First Received:	November 23, 2010
Last Updated:	September 27, 2012
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on May 21, 2013