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

NCT02322086 | Completed Phase 2

• 1 other identifier: PH-10-PS-24
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Psoriasis

Outcome Measures

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

  28 days

Secondary Outcomes (8)

• 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

Study Arms (1)

PH-10

EXPERIMENTAL

Active treatment

Drug: Topical Rose Bengal, 0.005%

Interventions

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).

Also known as: PH-10

PH-10

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Provectus Pharmaceuticals: lead

Study Sites (3)

International Dermatology Research

Miami, Florida, 33144, United States

Location

University of North Carolina School of Medicine

Chapel Hill, North Carolina, 27516, United States

Location

DermResearch Inc.

Austin, Texas, 78759, United States

Location

MeSH Terms

Conditions

Psoriasis

Interventions

Rose Bengal

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Fluoresceins; Spiro Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Xanthenes; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Polycyclic Compounds

Study Officials

• Eric Wachter, Ph.D.

  Provectus Biopharmaceuticals, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2014
• First Posted: December 22, 2014
• Study Start: January 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: June 1, 2017
• Last Updated: November 13, 2017

Record last verified: 2017-11

Locations

US (3)