Clinical trial NCT02656043: A Safety, Tolerability, Efficacy and Exposure Study of XEN801 Topical Gel
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Acne Vulgaris
Lead sponsor: Xenon Pharmaceuticals Inc.
Sponsor class: INDUSTRY
First posted: 2016-01-14
Enrollment: 213
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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).

Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline in acne lesion count
timeFrame: Week 12
Secondary outcomes:
measure: Change from Baseline in acne lesion count
timeFrame: Week 4 and 8
measure: Change from Baseline in Investigator Global Assessment (IGA)
timeFrame: Week 4, 8 and 12
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Kirk Barber Research
state: Alberta
city: Calgary
country: Canada
facility: Institute for Skin Advancement
state: Alberta
city: Edmonton
country: Canada
facility: Stratica Medical Inc.
state: Alberta
city: Surrey
country: Canada
facility: Dr. Chih-ho Hong Medical Inc.
state: British Columbia
city: Vancouver
country: Canada
facility: Carruthers & Humphrey Clinical Research
state: British Columbia
city: Vancouver
country: Canada
facility: Pacific Dermaesthetics
state: British Columbia
city: Winnipeg
country: Canada
facility: Toole Dermatology Research
state: Manitoba
city: Bathurst
country: Canada
facility: Clinique Médicale Nepisiguit
state: New Brunswick
city: Barrie
country: Canada
facility: SimcoDerm Medical and Surgical Dermatology Center
state: Ontario
city: Markham
country: Canada
facility: Lynderm Research Inc
state: Ontario
city: Mississauga
country: Canada
facility: DermEdge Research
state: Ontario
city: Oakville
country: Canada
facility: Research by ICLS
state: Ontario
city: Richmond Hill
country: Canada
facility: York Dermatology Center
state: Ontario
city: Toronto
country: Canada
facility: Bayview North Dermatology Clinic
state: Ontario
city: Toronto
country: Canada
facility: G. Daniel Schachter Medicine Professional Corporation
state: Ontario
city: Waterloo
country: Canada
facility: K. Papp Clinical Research Inc
state: Ontario
city: Windsor
country: Canada
facility: Windsor Clinical Research Inc.
state: Ontario
city: Montréal
country: Canada
facility: Innovaderm Research Inc.
state: Quebec
city: Saint-Jérôme
country: Canada
facility: Dre Angélique Gagné-Henley M.D. Inc
state: Quebec
city: Westmount
country: Canada
facility: Siena Medical Research Corporation
state: Quebec
Study officials:
affiliation: Xenon Pharmaceuticals Inc.
name: Xenon Pharmaceuticals Inc.
role: STUDY_DIRECTOR
References: