Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
99 participants
INTERVENTIONAL
2010-12-31
2012-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
PH-10 Treatment (High Dose Cohort)
PH-10 (0.01% Rose Bengal)
PH-10 will be applied daily for 28 days to skin areas affected by mild to moderate psoriasis.
PH-10 Treatment (Mid Dose Cohort)
PH-10 (0.005% Rose Bengal)
PH-10 will be applied daily for 28 days to skin areas affected by mild to moderate psoriasis.
PH-10 Treatment (Low Dose Cohort)
PH-10 (0.002% Rose Bengal)
PH-10 will be applied daily for 28 days to skin areas affected by mild to moderate psoriasis.
Vehicle Control
Vehicle
PH-10 vehicle will be applied daily for 28 days to skin areas affected by mild to moderate psoriasis.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
PH-10 (0.002% Rose Bengal)
PH-10 will be applied daily for 28 days to skin areas affected by mild to moderate psoriasis.
PH-10 (0.005% Rose Bengal)
PH-10 will be applied daily for 28 days to skin areas affected by mild to moderate psoriasis.
PH-10 (0.01% Rose Bengal)
PH-10 will be applied daily for 28 days to skin areas affected by mild to moderate psoriasis.
Vehicle
PH-10 vehicle will be applied daily for 28 days to skin areas affected by mild to moderate psoriasis.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Subjects who have received psoralen plus ultraviolet A (PUVA) therapy or systemic antipsoriatic therapy (immunosuppressants, cytostatics, corticosteroids) within 28 days of study initiation (two weeks for methotrexate).
* Subjects who have received ultraviolet B (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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Provectus Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Eric Wachter, Ph.D.
Role: STUDY_DIRECTOR
Provectus Pharmaceuticals
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Dermatology Specialists, Inc.
Oceanside, California, United States
International Dermatology Research
Miami, Florida, United States
Mount Sinai School of Medicine
New York, New York, United States
Wake Research Associates
Raleigh, North Carolina, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PH-10-PS-23
Identifier Type: -
Identifier Source: org_study_id