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Trial record 5 of 14 for:    Provectus

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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Provectus Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT02322086
First received: December 16, 2014
Last updated: September 15, 2015
Last verified: September 2015
  Purpose
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.

Condition Intervention Phase
Psoriasis
Drug: Topical Rose Bengal, 0.005%
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2 Study of Cellular and Immunologic Changes in the Skin of Subjects Receiving PH-10 Aqueous Hydrogel to Plaque Psoriasis

Resource links provided by NLM:


Further study details as provided by Provectus Pharmaceuticals:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Psoriasis Severity Index (PSI) changes from pre-treatment [ Time Frame: 28 days ]
  • Plaque Response changes from Day 1 pre-treatment [ Time Frame: 28 days ]
  • Pruritus Self-Assessment score changes from Day 1 pre-treatment [ Time Frame: 28 days ]
  • Correlation of PSI changes with observed histopathologic and immunohistopathologic changes in the skin of the target plaque [ Time Frame: 28 days ]
  • Incidence of adverse experiences [ Time Frame: 28 days ]
  • Incidence of adverse changes in clinical laboratory tests [ Time Frame: 28 days ]
  • Incidence of adverse changes in weight or vital signs [ Time Frame: 28 days ]
  • Correlation of adverse experiences with observed histopathologic and immunohistopathologic changes in the skin [ Time Frame: 28 days ]

Estimated Enrollment: 30
Study Start Date: January 2015
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PH-10
Active treatment
Drug: Topical Rose Bengal, 0.005%
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 Name: PH-10

  Eligibility

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).
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02322086

Locations
United States, Florida
International Dermatology Research
Miami, Florida, United States, 33144
United States, North Carolina
University of North Carolina School of Medicine
Chapel Hill, North Carolina, United States, 27516
United States, Texas
DermResearch Inc.
Austin, Texas, United States, 78759
Sponsors and Collaborators
Provectus Pharmaceuticals
Investigators
Study Director: Eric Wachter, Ph.D. Provectus Biopharmaceuticals, Inc.
  More Information

Responsible Party: Provectus Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02322086     History of Changes
Other Study ID Numbers: PH-10-PS-24
Study First Received: December 16, 2014
Last Updated: September 15, 2015

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

ClinicalTrials.gov processed this record on May 24, 2017