Clinical trial NCT02322086: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psoriasis
Lead sponsor: Provectus Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2014-12-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change in the immunologic, structural and hyperproliferative state of the skin in the target plaque and evidence of cellular atypia following PH-10 application
timeFrame: 28 days
Secondary outcomes:
measure: Psoriasis Severity Index (PSI) changes from pre-treatment
timeFrame: 28 days
measure: Plaque Response changes from Day 1 pre-treatment
timeFrame: 28 days
measure: Pruritus Self-Assessment score changes from Day 1 pre-treatment
timeFrame: 28 days
measure: Correlation of PSI changes with observed histopathologic and immunohistopathologic changes in the skin of the target plaque
timeFrame: 28 days
measure: Incidence of adverse experiences
timeFrame: 28 days
measure: Incidence of adverse changes in clinical laboratory tests
timeFrame: 28 days
measure: Incidence of adverse changes in weight or vital signs
timeFrame: 28 days
measure: Correlation of adverse experiences with observed histopathologic and immunohistopathologic changes in the skin
timeFrame: 28 days
Other outcomes:
Locations:
city: Miami
country: United States
facility: International Dermatology Research
state: Florida
city: Chapel Hill
country: United States
facility: University of North Carolina School of Medicine
state: North Carolina
city: Austin
country: United States
facility: DermResearch Inc.
state: Texas
Study officials:
affiliation: Provectus Biopharmaceuticals, Inc.
name: Eric Wachter, Ph.D.
role: STUDY_DIRECTOR
References: