Topical PH-10 Aqueous Hydrogel and Photodynamic Therapy for Psoriasis

This study has been terminated.
(Change of dose regimen (new protocol))
Sponsor:
Information provided by:
Provectus Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00555646
First received: November 7, 2007
Last updated: July 7, 2009
Last verified: July 2009

November 7, 2007
July 7, 2009
November 2007
June 2009   (final data collection date for 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 ]
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 ]
Complete list of historical versions of study NCT00555646 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Change in Pruritus of subject's treatment and control plaque areas using a self-assessment scale of 0-4. [ Time Frame: 12 weeks ]
  • 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 ]
  • Durability of Response based on plaque areas exhibiting Treatment Success that retain this level of response. [ Time Frame: 16 weeks ]
  • Adverse Experience. [ Time Frame: 16 weeks ]
Not Provided
Not Provided
 
Topical PH-10 Aqueous Hydrogel and Photodynamic Therapy for Psoriasis
A Phase 2 Study of Topical PH-10 Aqueous Hydrogel and Photodynamic Therapy for the Treatment of Plaque Psoriasis

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.

Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Plaque Psoriasis
  • Drug: PH-10 (rose bengal disodium 0.001%)

    PH-10 with 544 nm LED light illumination

    OR

    PH-10 with ambient light exposure

  • Drug: Control
    No treatment control.
Experimental: 1
Each subject's study plaque areas will be assigned by the investigator to two PH-10 treatment plaque areas and one control plaque area.
Interventions:
  • Drug: PH-10 (rose bengal disodium 0.001%)
  • Drug: Control
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
25
July 2009
June 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00555646
PH-10-PS-21
No
Eric Wachter, Ph.D./Vice President, Provectus Pharmaceuticals, Inc.
Provectus Pharmaceuticals
Not Provided
Principal Investigator: Amir Larian, MD Mount Sinai School of Medicine
Provectus Pharmaceuticals
July 2009

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