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

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

Tracking Information
First Submitted Date  ICMJE December 16, 2014
First Posted Date  ICMJE December 22, 2014
Last Update Posted Date November 13, 2017
Actual Study Start Date  ICMJE January 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History Complete list of historical versions of study NCT02322086 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase 2 Study of Cellular and Immunologic Changes in the Skin of Subjects Receiving PH-10
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Psoriasis
Intervention  ICMJE 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  ICMJE Experimental: PH-10
Active treatment
Intervention: Drug: Topical Rose Bengal, 0.005%
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 19, 2014)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2017
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02322086
Other Study ID Numbers  ICMJE PH-10-PS-24
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Provectus Pharmaceuticals
Study Sponsor  ICMJE Provectus Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Eric Wachter, Ph.D. Provectus Biopharmaceuticals, Inc.
PRS Account Provectus Pharmaceuticals
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP