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Randomized Study of PH-10 for Psoriasis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01247818
First Posted: November 24, 2010
Last Update Posted: September 28, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Provectus Pharmaceuticals
  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
Intervention Model: Parallel Assignment
Masking: Single (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:


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 ]
  • 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 Measures:
  • Psoriasis Severity Index (PSI) score changes at each visit from Day 1 pre-treatment. [ Time Frame: 8 weeks ]
  • Plaque Response score changes at each visit from Day 1 pre-treatment. [ Time Frame: 8 weeks ]
  • Pruritus Self-Assessment score changes at each visit from Day 1 pre-treatment. [ Time Frame: 8 weeks ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Provectus Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01247818     History of Changes
Other Study ID Numbers: PH-10-PS-23
First Submitted: November 23, 2010
First Posted: November 24, 2010
Last Update Posted: September 28, 2012
Last Verified: September 2012

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases