A Phase 2 interventional study of PH-10 (0.001% Rose Bengal) in Psoriasis, sponsored by Provectus Pharmaceuticals. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-07-07.
Sponsored by Provectus Pharmaceuticals · Phase 2, Interventional, and Treatment
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.
1,928 studies on the registry are indexed under Psoriasis; 234 are open to participants now.
This study's planned enrollment of 30 is below the median of 70 across 1,472 interventional studies indexed under Psoriasis.
Browse Psoriasis studies →Provectus Pharmaceuticals is the lead sponsor of 8 studies on the registry; none are open to participants now.
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Drug: PH-10 (0.001% Rose Bengal)
PH-10 will be applied daily for 28 days to skin areas affected by mild to moderate psoriasis.
The primary efficacy endpoint is "Treatment Success," a static endpoint assessed at Day 29 after initial PH-10 treatment and defined as 0 or 1 on all Psoriasis Severity Index (PSI) components and 0 or 1 on the Plaque Response scale.
Time frame: 28 days
The primary safety endpoint is incidence of adverse experiences, including pain and dermatologic/skin toxicity (incidence, severity, frequency, duration and causality).
Time frame: 8 weeks
Psoriasis Severity Index (PSI) score changes at each visit from Day 1 pre-treatment.
Time frame: 8 weeks
Plaque Response score changes at each visit from Day 1 pre-treatment.
Time frame: 8 weeks
Pruritus Self-Assessment score changes at each visit from Day 1 pre-treatment.
Time frame: 8 weeks
This study is completed, as verified in Jul 2010. You cannot join it, but the record below documents what was studied.
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Provectus Pharmaceuticals