A Phase 1/2 interventional study of XPF-005 and Placebo in Acne Vulgaris, sponsored by Xenon Pharmaceuticals Inc.. Completed at 20 sites in Canada. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-01-22.
Sponsored by Xenon Pharmaceuticals Inc. · Phase 1/2, Interventional, and Treatment
Phase 1/2 study enrolling up to 60 healthy volunteers in Phase 1 followed by approximately 150 subjects with acne vulgaris in Phase 2.
Phase 1/2 study enrolling up to 60 healthy volunteers followed by approximately 150 subjects with acne vulgaris. Data from Phase 1 stage will be reviewed before progressing to Phase 2.
Phase 1 is an open label study to determine safety, tolerability of XPF-005 topical gel and exposure of XEN801 (active ingredient). Up to 5 cohorts of 12 healthy volunteers will each receive different dose volumes of XPF-005 gel or Placebo gel on their face and back for 14 or 21 days. Safety assessments are completed and PK samples are collected at study visits.
Phase 2 is a randomized, double-blind, vehicle-controlled, parallel-group study to determine safety, tolerability, efficacy of XPF-005 topical gel and exposure of XEN801 (active ingredient). Approximately 150 subjects with acne vulgaris will apply XPF-005 or matching placebo gel on their face for 12 weeks. Safety and efficacy assessments are completed and PK samples are collected at study visits.
Safety assessments include local skin tolerability assessments, vital signs, physical examination, 12-lead ECG, safety laboratory blood and urine and adverse event reporting.
Efficacy assessments include acne lesion counts and Investigator's Global Assessment (IGA).
730 studies on the registry are indexed under Acne Vulgaris; 86 are open to participants now.
This study's enrollment of 213 is above the median of 69 across 628 interventional studies indexed under Acne Vulgaris.
Browse Acne Vulgaris studies →Xenon Pharmaceuticals Inc. is the lead sponsor of 23 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Clinical diagnosis of facial acne vulgaris defined as:
Key Exclusion Criteria:
Active treatment: XPF-005 Gel
Drug: XPF-005
Placebo: XPF-005 Vehicle Gel
Drug: Placebo
Comparison of active treatment XPF-005 topical gel against Placebo (XPF-005 Vehicle Gel) applied to face for acne vulgaris.
Change from Baseline in acne lesion count
Time frame: Week 12
Change from Baseline in acne lesion count
Time frame: Week 4 and 8
Change from Baseline in Investigator Global Assessment (IGA)
Time frame: Week 4, 8 and 12
This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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Xenon Pharmaceuticals Inc.