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An Efficacy and Safety Study of PH-10 Aqueous Hydrogel for the Treatment of Plaque Psoriasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00941278
Recruitment Status : Completed
First Posted : July 17, 2009
Last Update Posted : July 7, 2010
Sponsor:
Information provided by:
Provectus Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE July 15, 2009
First Posted Date  ICMJE July 17, 2009
Last Update Posted Date July 7, 2010
Study Start Date  ICMJE July 2009
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 16, 2009)
  • The primary efficacy endpoint is "Treatment Success," a static endpoint assessed at Day 29 after initial PH-10 treatment and defined as 0 or 1 on all Psoriasis Severity Index (PSI) components and 0 or 1 on the Plaque Response scale. [ Time Frame: 28 days ]
  • The primary safety endpoint is incidence of adverse experiences, including pain and dermatologic/skin toxicity (incidence, severity, frequency, duration and causality). [ Time Frame: 8 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 16, 2009)
  • Psoriasis Severity Index (PSI) score changes at each visit from Day 1 pre-treatment. [ Time Frame: 8 weeks ]
  • Plaque Response score changes at each visit from Day 1 pre-treatment. [ Time Frame: 8 weeks ]
  • Pruritus Self-Assessment score changes at each visit from Day 1 pre-treatment. [ Time Frame: 8 weeks ]
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 An Efficacy and Safety Study of PH-10 Aqueous Hydrogel for the Treatment of Plaque Psoriasis
Official Title  ICMJE Not Provided
Brief Summary PH-10 is an aqueous hydrogel formulation of rose bengal disodium (RB) for topical administration to the skin, and is being studied for the treatment of cutaneous skin disorders, specifically psoriasis and atopic dermatitis. This phase 2 efficacy and safety study will assess topical PH-10 applied once daily to areas of mild to moderate plaque psoriasis.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Psoriasis
Intervention  ICMJE Drug: PH-10 (0.001% Rose Bengal)
PH-10 will be applied daily for 28 days to skin areas affected by mild to moderate psoriasis.
Study Arms  ICMJE Experimental: PH-10 Treatment
Intervention: Drug: PH-10 (0.001% Rose Bengal)
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
Estimated Enrollment  ICMJE
 (submitted: July 16, 2009)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2010
Actual Primary Completion Date December 2009   (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).
  • Fitzpatrick skin type I-VI.
  • Written informed consent by the subject or legal guardian.

Exclusion Criteria:

  • Women of childbearing potential who are pregnant, attempting to conceive, not using effective contraception, or who are nursing an infant.
  • Subjects who have received PUVA or systemic antipsoriatic therapy (immunosuppressants, cytostatics, corticosteroids) within 28 days of study initiation (two weeks 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 agents posing a clinically significant risk of photosensitivity reaction within 5 half-lives 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 by being involved 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 NCT00941278
Other Study ID Numbers  ICMJE PH-10-PS-22
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eric Wachter/Vice President, Provectus Pharmaceuticals
Study Sponsor  ICMJE Provectus Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Eric Wachter, PhD Provectus Pharmaceuticals
PRS Account Provectus Pharmaceuticals
Verification Date July 2010

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