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Completed

NCT Number: NCT01247818

Randomized Study of PH-10 for 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Dermatology Specialists, Inc., Oceanside, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PH-10 (0.002% Rose Bengal)

Drug

PH-10 will be applied daily for 28 days to skin areas affected by mild to moderate psoriasis.

PH-10 (0.005% Rose Bengal)

Drug

PH-10 will be applied daily for 28 days to skin areas affected by mild to moderate psoriasis.

PH-10 (0.01% Rose Bengal)

Drug

PH-10 will be applied daily for 28 days to skin areas affected by mild to moderate psoriasis.

Vehicle

Drug

PH-10 vehicle will be applied daily for 28 days to skin areas affected by mild to moderate psoriasis.

Primary outcomes

  1. 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

  2. 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 outcomes

  1. Psoriasis Severity Index (PSI) score changes at each visit from Day 1 pre-treatment.

    Time frame: 8 weeks

  2. Plaque Response score changes at each visit from Day 1 pre-treatment.

    Time frame: 8 weeks

  3. Pruritus Self-Assessment score changes at each visit from Day 1 pre-treatment.

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Provectus Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Nov 24, 2010
Registry last updated
Sep 28, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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