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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Plaque Psoriasis
 Drug: PH-10 (rose bengal disodium 0.001%)
Drug: Control
 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2 Study of Topical PH-10 Aqueous Hydrogel and Photodynamic Therapy for the Treatment of Plaque Psoriasis

Resource links provided by NLM:

MedlinePlus related topics: Psoriasis
U.S. FDA Resources

Further study details as provided by Provectus Pharmaceuticals:

Primary Outcome Measures:
  • 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 Measures:
  • 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 ]

Estimated Enrollment: 25
Study Start Date: November 2007
Estimated Study Completion Date: July 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00555646

Locations
United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029
Sponsors and Collaborators
Provectus Pharmaceuticals
Investigators
Principal Investigator: Amir Larian, MD Mount Sinai School of Medicine
  More Information

No publications provided

Responsible Party: Eric Wachter, Ph.D./Vice President, Provectus Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00555646     History of Changes
Other Study ID Numbers: PH-10-PS-21
Study First Received: November 7, 2007
Last Updated: July 7, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on May 23, 2013