Date: 2016-12-29
Type of information: Initiation of preclinical development
phase: 2
Announcement:
Company: Provectus Pharmaceuticals (USA - TN)
Product: PH-10
Action mechanism:
Disease: psoriasis
Therapeutic area: Autoimmune diseases - Dermatological diseases
Country: USA
Trial
details: This is a multicenter study of subjects with mild to moderate psoriasis. Subjects will apply PH-10 vehicle daily for 28 consecutive days followed by active PH-10 daily for 28 consecutive days to their plaque psoriasis areas on the trunk or extremities (excluding palms, soles, scalp, facial and intertriginous sites). Biopsies of one target plaque will be collected at baseline (at least 7 days prior to first study treatment on Day 1) and at Days 29 and 64, with a 7-day interval between biopsy at Day 29 and commencement of application of application of active PH-10 on Day 36. Study data from each subject will serve as an internal control (i.e., assessment at baseline and at the end of application of PH-10 vehicle) for assessment of clinical and cellular response to active investigational agent. (NCT02322086)
Latest
news: * On September 21, 2015, Provectus Biopharmaceuticals announced that it has completed patient accrual for its phase 2 study of the cellular and immunologic changes in the skin of patients receiving PH-10, an investigational topical treatment for atopic dermatitis and psoriasis. This phase 2 trial is a multicenter study of subjects with mild to moderate psoriasis. Subjects apply PH-10 vehicle daily for 28 consecutive days followed by active PH-10 daily for 28 consecutive days to their plaque psoriasis areas on the trunk or extremities (excluding palms, soles, scalp, facial and intertriginous sites). Biopsies of one target plaque are collected at baseline (at least 7 days prior to first study treatment on Day 1) and at Days 29 and 64, with a 7-day interval between biopsy at Day 29 and commencement of application of active PH-10 on Day 36. Study data from each subject will serve as an internal control (i.e., assessment at baseline and at the end of application of PH-10 vehicle) for assessment of clinical and cellular response to active investigational agent.
