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An Efficacy and Safety Study of PH-10 Aqueous Hydrogel for the Treatment of Plaque Psoriasis

This study has been completed.
Sponsor:
Information provided by:
Provectus Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00941278
First received: July 15, 2009
Last updated: July 2, 2010
Last verified: July 2010
History of Changes
  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 phase 2 efficacy and safety study will assess topical PH-10 applied once daily to areas of mild to moderate plaque psoriasis.


Condition Intervention Phase
Psoriasis
 Drug: PH-10 (0.001% Rose Bengal)
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Psoriasis
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 ]

Estimated Enrollment: 30
Study Start Date: July 2009
Study Completion Date: April 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PH-10 Treatment Drug: PH-10 (0.001% Rose Bengal)
PH-10 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:

  • Women of childbearing potential who are pregnant, attempting to conceive, not using effective contraception, or who are nursing an infant.
  • Subjects who have received PUVA or systemic antipsoriatic therapy (immunosuppressants, cytostatics, corticosteroids) within 28 days of study initiation (two weeks for methotrexate).
  • Subjects who have received 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: NCT00941278

Locations
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
Sponsors and Collaborators
Provectus Pharmaceuticals
Investigators
Study Director: Eric Wachter, PhD Provectus Pharmaceuticals
  More Information

No publications provided

Responsible Party: Eric Wachter/Vice President, Provectus Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00941278     History of Changes
Other Study ID Numbers: PH-10-PS-22
Study First Received: July 15, 2009
Last Updated: July 2, 2010
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 22, 2013