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

Completed · Phase 2

Conditions studied: Psoriasis

In brief

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.

Key facts

Study ID

NCT00941278

Run by

Provectus Pharmaceuticals

People needed

30

Starts

2009-07-01

Expected to finish

2010-04-01

Last updated by the study team

2010-07-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• International Dermatology Research — Miami, Florida, United States
• Mount Sinai School of Medicine — New York, New York, United States

Full record on ClinicalTrials.gov

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