A Safety, Tolerability, Efficacy and Exposure Study of XEN801 Topical Gel

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

Phase 1/2 study enrolling up to 60 healthy volunteers in Phase 1 followed by approximately 150 subjects with acne vulgaris in Phase 2.

Study Overview

• Status: Completed
• Conditions: Acne Vulgaris
• Intervention / Treatment: Drug: Placebo; Drug: XPF-005

Detailed 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).

• Study Type: Interventional
• Enrollment (Actual): 213
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2G 1B1
      • Kirk Barber Research
    • Calgary, Alberta, Canada, T3A 2N1
      • Institute For Skin Advancement
    • Edmonton, Alberta, Canada, T5K 1X3
      • Stratica Medical Inc.
  • British Columbia
    • Surrey, British Columbia, Canada, V3R 6A7
      • Dr. Chih-ho Hong Medical Inc.
    • Vancouver, British Columbia, Canada, V6E 4M3
      • Pacific Dermaesthetics
    • Vancouver, British Columbia, Canada, V5Z 4E1
      • Carruthers & Humphrey Clinical Research
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3C 1R4
      • Toole Dermatology Research
  • New Brunswick
    • Bathurst, New Brunswick, Canada, E2A 4Z9
      • Clinique Medicale Nepisiguit
  • Ontario
    • Barrie, Ontario, Canada, L4M 7G1
      • SimcoDerm Medical and Surgical Dermatology Center
    • Markham, Ontario, Canada, L3P 1X2
      • Lynderm Research Inc
    • Mississauga, Ontario, Canada, L5H 1G9
      • DermEdge Research
    • Oakville, Ontario, Canada, L6J 7W5
      • Research by ICLS
    • Richmond Hill, Ontario, Canada, L4C 9M7
      • York Dermatology Center
    • Toronto, Ontario, Canada, M2M 4J5
      • Bayview North Dermatology Clinic
    • Toronto, Ontario, Canada, M5S 3B4
      • G. Daniel Schachter Medicine Professional Corporation
    • Waterloo, Ontario, Canada, N2J 1C4
      • K. Papp Clinical Research Inc
    • Windsor, Ontario, Canada, N8W 5L7
      • Windsor Clinical Research Inc.
  • Quebec
    • Montréal, Quebec, Canada, H2K4L5
      • Innovaderm Research Inc.
    • Saint-Jérôme, Quebec, Canada, J7Z 3B8
      • Dre Angelique Gagne-Henley M.D. Inc
    • Westmount, Quebec, Canada, H3Z 2S6
      • Siena Medical Research Corporation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Key Inclusion Criteria:

1. Aged between 18 and 50, inclusive
2. Male or female, agree to comply with contraceptive requirements
3. Signed Informed Consent Form

4. Clinical diagnosis of facial acne vulgaris defined as:

   • 25 to 75 inflammatory lesions,
   • 20 to 120 non-inflammatory lesions, and
   • an IGA score of ≥3
5. 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:

1. Known sensitivity to any topical or dermal product, including alcohol
2. Female who is breast feeding, pregnant, or planning to become pregnant
3. Any skin condition of the face other than acne vulgaris
4. Two or more active nodular lesions
5. Excessive facial hair that would interfere with the evaluation of safety or with the diagnosis or assessment of acne vulgaris
6. Use of tanning beds/booths, or excessive sun exposure
7. Use of over-the-counter topical medications for treatment of acne vulgaris on the face within 14 days of baseline
8. Use of systemic corticosteroids, antibiotics, anti-acne drugs, anti-inflammatory drugs (NSAIDs are permitted) or prescription topical retinoid use on the face within 28 days prior the baseline
9. Initiation of hormonal therapy or dose change to hormonal therapy within 12 weeks prior to baseline.
10. Use of androgen receptor blockers (eg, spironolactone, flutamide) within 12 weeks prior to baseline
11. Use of oral retinoid (eg, isotretinoin, alitretinoin) within 12 months prior to baseline and vitamin A supplements >10,000 units/day within 6 months prior to baseline
12. Facial procedures (eg, microdermabrasion, chemical or laser peel) within 8 weeks prior to baseline
13. Photodynamic therapy within 12 weeks prior to baseline
14. Any other reason that would make the subject, in the opinion of the Investigator or Sponsor, unsuitable for the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: XPF-005; Active treatment: XPF-005 Gel	Drug: XPF-005; 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	Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from Baseline in acne lesion count	Week 12

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from Baseline in acne lesion count	Week 4 and 8
Change from Baseline in Investigator Global Assessment (IGA)	Week 4, 8 and 12

Collaborators and Investigators

• Sponsor: Xenon Pharmaceuticals Inc.
• Investigators: Study Director: Xenon Pharmaceuticals Inc., Xenon Pharmaceuticals Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 17, 2015
• Primary Completion (ACTUAL): February 16, 2017
• Study Completion (ACTUAL): March 17, 2017

Study Registration Dates

• First Submitted: January 12, 2016
• First Submitted That Met QC Criteria: January 12, 2016
• First Posted (ESTIMATE): January 14, 2016

Study Record Updates

• Last Update Posted (ACTUAL): January 22, 2019
• Last Update Submitted That Met QC Criteria: January 17, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris
• Other Study ID Numbers: XPF-005-101