A Phase 2 interventional study of Topical Rose Bengal, 0.005% in Psoriasis, sponsored by Provectus Pharmaceuticals. Completed at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-11-13.
Sponsored by Provectus Pharmaceuticals · Phase 2, Interventional, and Treatment
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.
1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.
This study's enrollment of 30 is below the median of 70 across 1,447 interventional studies indexed under Psoriasis.
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Active treatment
Drug: Topical Rose Bengal, 0.005%
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).
Also known as: PH-10
Change in the immunologic, structural and hyperproliferative state of the skin in the target plaque and evidence of cellular atypia following PH-10 application
Time frame: 28 days
Psoriasis Severity Index (PSI) changes from pre-treatment
Time frame: 28 days
Plaque Response changes from Day 1 pre-treatment
Time frame: 28 days
Pruritus Self-Assessment score changes from Day 1 pre-treatment
Time frame: 28 days
Correlation of PSI changes with observed histopathologic and immunohistopathologic changes in the skin of the target plaque
Time frame: 28 days
Incidence of adverse experiences
Time frame: 28 days
Incidence of adverse changes in clinical laboratory tests
Time frame: 28 days
Incidence of adverse changes in weight or vital signs
Time frame: 28 days
Correlation of adverse experiences with observed histopathologic and immunohistopathologic changes in the skin
Time frame: 28 days
This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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Provectus Pharmaceuticals