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

Primary Purpose

Psoriasis

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Topical Rose Bengal, 0.005%

About this trial

This is an interventional treatment trial for Psoriasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

International Dermatology Research
University of North Carolina School of Medicine
DermResearch Inc.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PH-10

Arm Description

Active treatment

Outcomes

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

Secondary Outcome Measures

Psoriasis Severity Index (PSI) changes from pre-treatment

Plaque Response changes from Day 1 pre-treatment

Pruritus Self-Assessment score changes from Day 1 pre-treatment

Correlation of PSI changes with observed histopathologic and immunohistopathologic changes in the skin of the target plaque

Incidence of adverse experiences

Incidence of adverse changes in clinical laboratory tests

Incidence of adverse changes in weight or vital signs

Correlation of adverse experiences with observed histopathologic and immunohistopathologic changes in the skin

Full Information

NCT ID

NCT02322086

First Posted

December 16, 2014

Last Updated

November 8, 2017

Sponsor

Provectus Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT02322086

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2017

Overall Recruitment Status

Completed

Study Start Date

January 2015 (Actual)

Primary Completion Date

December 2015 (Actual)

Study Completion Date

June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Provectus Pharmaceuticals

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Psoriasis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PH-10

Arm Type

Experimental

Arm Description

Active treatment

Intervention Type

Drug

Intervention Name(s)

Topical Rose Bengal, 0.005%

Other Intervention Name(s)

PH-10

Intervention Description

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).

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

Psoriasis Severity Index (PSI) changes from pre-treatment

Time Frame

28 days

Title

Plaque Response changes from Day 1 pre-treatment

Time Frame

28 days

Title

Pruritus Self-Assessment score changes from Day 1 pre-treatment

Time Frame

28 days

Title

Correlation of PSI changes with observed histopathologic and immunohistopathologic changes in the skin of the target plaque

Time Frame

28 days

Title

Incidence of adverse experiences

Time Frame

28 days

Title

Incidence of adverse changes in clinical laboratory tests

Time Frame

28 days

Title

Incidence of adverse changes in weight or vital signs

Time Frame

28 days

Title

Correlation of adverse experiences with observed histopathologic and immunohistopathologic changes in the skin

Time Frame

28 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Eric Wachter, Ph.D.

Organizational Affiliation

Provectus Biopharmaceuticals, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

International Dermatology Research

City

Miami

State/Province

Florida

ZIP/Postal Code

33144

Country

United States

Facility Name

University of North Carolina School of Medicine

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27516

Country

United States

Facility Name

DermResearch Inc.

City

Austin

State/Province

Texas

ZIP/Postal Code

78759

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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