A Safety, Tolerability, Efficacy and Exposure Study of XEN801 Topical Gel
|ClinicalTrials.gov Identifier: NCT02656043|
Recruitment Status : Completed
First Posted : January 14, 2016
Last Update Posted : January 22, 2019
|Condition or disease||Intervention/treatment||Phase|
|Acne Vulgaris||Drug: XPF-005 Drug: Placebo||Phase 1 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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||213 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 1 and 2 Randomized, Double-Blind, Vehicle-Controlled, Parallel-Group Study to Evaluate the Safety, Tolerability, Efficacy, and Exposure of up to 12 Weeks of XPF-005 Treatment in Healthy Volunteers and Subjects With Acne Vulgaris|
|Actual Study Start Date :||September 17, 2015|
|Actual Primary Completion Date :||February 16, 2017|
|Actual Study Completion Date :||March 17, 2017|
Active Comparator: XPF-005
Active treatment: XPF-005 Gel
Comparison of active treatment XPF-005 topical gel against Placebo (XPF-005 Vehicle Gel) applied to face for acne vulgaris.
Placebo Comparator: Vehicle gel
Placebo: XPF-005 Vehicle Gel
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02656043
|Study Director:||Xenon Pharmaceuticals Inc.||Xenon Pharmaceuticals Inc.|