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

• ClinicalTrials.gov Identifier: NCT02322086
• Recruitment Status: Completed
• First Posted: December 22, 2014
• Last Update Posted: November 13, 2017
• Sponsor: Provectus Pharmaceuticals
• Information provided by (Responsible Party): Provectus Pharmaceuticals

Tracking Information

• First Submitted Date: December 16, 2014
• First Posted Date: December 22, 2014
• Last Update Posted Date: November 13, 2017
• Actual Study Start Date: January 2015
• Actual Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: December 19, 2014): 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 ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: December 19, 2014)

• 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 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Phase 2 Study of Cellular and Immunologic Changes in the Skin of Subjects Receiving PH-10
• Official Title: A Phase 2 Study of Cellular and Immunologic Changes in the Skin of Subjects Receiving PH-10 Aqueous Hydrogel to Plaque Psoriasis
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Psoriasis

Intervention

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

Study Arms

Experimental: PH-10

Active treatment

Intervention: Drug: Topical Rose Bengal, 0.005%

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 19, 2014): 30
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: June 2017
• Actual Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02322086
• Other Study ID Numbers: PH-10-PS-24
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Provectus Pharmaceuticals
• Study Sponsor: Provectus Pharmaceuticals
• Collaborators: Not Provided

Investigators

• Study Director: Eric Wachter, Ph.D.; Provectus Biopharmaceuticals, Inc.

• PRS Account: Provectus Pharmaceuticals
• Verification Date: November 2017