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Phase 1/2 study enrolling up to 60 healthy volunteers in Phase 1 followed by approximately 150 subjects with acne vulgaris in Phase 2.
Full description
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).
Enrollment
Sex
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Volunteers
Inclusion and exclusion criteria
Key Inclusion Criteria:
Aged between 18 and 50, inclusive
Male or female, agree to comply with contraceptive requirements
Signed Informed Consent Form
Clinical diagnosis of facial acne vulgaris defined as:
Agree to refrain from using any topical acne treatments on the face or any oral acne treatments. Topical acne treatment that do not have significant or measurable systemic absorption are permitted for treatment of the back, shoulders, and chest only
Key Exclusion Criteria:
Primary purpose
Allocation
Interventional model
Masking
213 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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