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

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

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.

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Drug: Topical Rose Bengal, 0.005%

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33144
      • International Dermatology Research
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27516
      • University of North Carolina School of Medicine
  • Texas
    • Austin, Texas, United States, 78759
      • DermResearch Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: PH-10

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in the immunologic, structural and hyperproliferative state of the skin in the target plaque and evidence of cellular atypia following PH-10 application	28 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Provectus Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2015
• Primary Completion (ACTUAL): December 1, 2015
• Study Completion (ACTUAL): June 1, 2017

Study Registration Dates

• First Submitted: December 16, 2014
• First Submitted That Met QC Criteria: December 19, 2014
• First Posted (ESTIMATE): December 22, 2014

Study Record Updates

• Last Update Posted (ACTUAL): November 13, 2017
• Last Update Submitted That Met QC Criteria: November 8, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: PH-10-PS-24