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Completed

NCT Number: NCT02322086

A Phase 2 Study of Cellular and Immunologic Changes in the Skin of Subjects Receiving PH-10

This is a multicenter study of subjects with mild to moderate psoriasis. Subjects will apply PH-10 vehicle daily for 28 consecutive days followed by active PH-10 daily for 28 consecutive days to their plaque psoriasis areas on the trunk or extremities (excluding palms, soles, scalp, facial and intertriginous sites). Biopsies of one target plaque will be collected at baseline (at least 7 days prior to first study treatment on Day 1) and at Days 29 and 64, with a 7-day interval between biopsy at Day 29 and commencement of application of application of active PH-10 on Day 36. Study data from each subject will serve as an internal control (i.e., assessment at baseline and at the end of application of PH-10 vehicle) for assessment of clinical and cellular response to active investigational agent.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

International Dermatology Research, Miami, Florida, 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).
  • At least one target plaque having a minimum diameter of 5 cm (2 inches) with uniform mild to moderate plaque psoriasis.
  • 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 PH-10.
  • Subjects who have received PUVA or systemic antipsoriatic therapy (immunosuppressants, cytostatics, corticosteroids) within 28 days of study initiation (14 days 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 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 because of involvement in the study or detrimentally affect regular follow-up of the subject.

Treatment and study plan

Topical Rose Bengal, 0.005%

Drug

Subjects will apply PH-10 vehicle daily for 28 consecutive days followed by active PH-10 daily for 28 consecutive days to their plaque psoriasis areas on the trunk or extremities (excluding palms, soles, scalp, facial and intertriginous sites).

Other names: PH-10

Primary outcomes

  1. Change in the immunologic, structural and hyperproliferative state of the skin in the target plaque and evidence of cellular atypia following PH-10 application

    Time frame: 28 days

Secondary outcomes

  1. Psoriasis Severity Index (PSI) changes from pre-treatment

    Time frame: 28 days

  2. Plaque Response changes from Day 1 pre-treatment

    Time frame: 28 days

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

    Time frame: 28 days

  4. Correlation of PSI changes with observed histopathologic and immunohistopathologic changes in the skin of the target plaque

    Time frame: 28 days

  5. Incidence of adverse experiences

    Time frame: 28 days

  6. Incidence of adverse changes in clinical laboratory tests

    Time frame: 28 days

  7. Incidence of adverse changes in weight or vital signs

    Time frame: 28 days

  8. Correlation of adverse experiences with observed histopathologic and immunohistopathologic changes in the skin

    Time frame: 28 days

Sponsors and collaborators

Lead sponsor

Provectus Pharmaceuticals

Industry

Registry information

Official study title

A Phase 2 Study of Cellular and Immunologic Changes in the Skin of Subjects Receiving PH-10 Aqueous Hydrogel to Plaque Psoriasis

Important dates

Study start
2015
Primary completion
2015
Study completion
2017
First posted
Dec 22, 2014
Registry last updated
Nov 13, 2017

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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