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Topical PH-10 Aqueous Hydrogel and Photodynamic Therapy for Psoriasis

This study is currently recruiting participants.
Information provided by Provectus Pharmaceuticals

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Descriptive Information Fields
Brief Title  Topical PH-10 Aqueous Hydrogel and Photodynamic Therapy for Psoriasis
Official Title  A Phase 2 Study of Topical PH-10 Aqueous Hydrogel and Photodynamic Therapy for the Treatment of Plaque Psoriasis
Brief Summary

This is an open label, single center, controlled study with each subject's two treatment plaque areas assigned by the investigator 1:1 to (a) PH-10 with ambient light exposure and (b) PH-10 with 544 nm LED light illumination at 10 J/cm2. A third plaque area will receive no treatment and serve as a control.

Subjects with at least three distinct, stable study plaque areas will receive the experimental therapy to two treatment plaque areas twice a week (2-5 days apart) for the lesser of 12 weeks or until remission is observed in the treatment plaque areas. If remission is observed in a treatment plaque area then treatment of that area will be discontinued and the area assessed weekly. A third plaque area (control plaque area) will receive no drug or light treatment and serve as an internal control.

Primary efficacy will be assessed 12 weeks after initial PH-10 treatment. Subjects will be followed for a total of 16 weeks to allow assessment of Durability of Response of treated lesions and comprehensive follow-up of adverse events.

Detailed Description
Study Phase Phase II
Study Type  Interventional
Study Design  Treatment, Open Label, Single Group Assignment
Primary Outcome Measure  Treatment Success, defined as 0 or 1 on all Psoriasis Severity Index components (erythema, induration, and scaling) and 0 or 1 on the Plaque Response scale. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measure  Change in Pruritus of subject's treatment and control plaque areas using a self-assessment scale of 0-4. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Time to Remission (TTR) based on the (a) number of treatments and (b) days elapsed until Treatment Success is noted in each treatment plaque area. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Durability of Response based on plaque areas exhibiting Treatment Success that retain this level of response. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Adverse Experience. [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
Condition  Plaque Psoriasis
Intervention  Drug: PH-10 (rose bengal disodium 0.001%)
Drug: Control
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  25
Start Date  November 2007
Completion Date August 2008
Eligibility Criteria 

Inclusion Criteria:

  • Stable, moderate to severe plaque psoriasis in at least three distinct plaque areas, each separated by at least a 2.5-cm band of normal skin. Study plaque areas, each covering a contiguous area up to 15 x 35 cm in size, should have a minimum plaque size of 2 cm2. All study plaque areas must be on the trunk or extremities (excluding palms, soles, scalp, and facial or intertriginous sites).
  • Fitzpatrick skin type I-VI.
  • Ability to understand and sign the informed consent document.

Exclusion Criteria:

  • Female subjects of childbearing potential who are pregnant, attempting to conceive, or nursing an infant.
  • Subjects who have received PUVA or UVB light therapy or systemic antipsoriatic therapy within 4 weeks of study treatment (two weeks for methotrexate).
  • Subjects who have received topical antipsoriatic therapy (including corticosteroids, tar, anthralin, or Vitamin D analogs) to the study plaque areas within 2 weeks of study treatment.
  • Subjects who have received any photosensitizing or phototoxic drug within 4 weeks of study treatment.
  • Subjects who have received any approved biologic drug therapy for psoriasis within 3 months or 5 half-lives of study treatment.
  • Subjects who have participated in a clinical research study within 4 weeks of study treatment.
  • Subjects with a history of porphyria, systemic lupus erythematosus or xeroderma pigmentosum.
  • Subjects with clinical conditions that, in the opinion of the Principal Investigator, may pose a health risk to the subject by being involved in the study or detrimentally affect regular follow-up of the subject.
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Contact: Giselle Singer     (212) 241-3288     Giselle.Singer@mssm.edu    
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00555646
Organization ID PH-10-PS-21
Secondary IDs ††
Study Sponsor  Provectus Pharmaceuticals
Collaborators ††
Investigators 
Principal Investigator:     Amir Larian, MD     Mount Sinai School of Medicine    
Information Provided By Provectus Pharmaceuticals
Verification Date March 2008
First Received Date  November 7, 2007
Last Updated Date March 21, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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