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
1 other identifier
interventional
213
1 country
20
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Sep 2015
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 17, 2015
CompletedFirst Submitted
Initial submission to the registry
January 12, 2016
CompletedFirst Posted
Study publicly available on registry
January 14, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 16, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 17, 2017
CompletedJanuary 22, 2019
January 1, 2019
1.4 years
January 12, 2016
January 17, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Change from Baseline in acne lesion count
Week 12
Secondary Outcomes (2)
Change from Baseline in acne lesion count
Week 4 and 8
Change from Baseline in Investigator Global Assessment (IGA)
Week 4, 8 and 12
Study Arms (2)
XPF-005
ACTIVE COMPARATORActive treatment: XPF-005 Gel
Vehicle gel
PLACEBO COMPARATORPlacebo: XPF-005 Vehicle Gel
Interventions
Eligibility Criteria
You may qualify if:
- 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:
- to 75 inflammatory lesions,
- to 120 non-inflammatory lesions, and
- an IGA score of ≥3
- 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
You may not qualify if:
- Known sensitivity to any topical or dermal product, including alcohol
- Female who is breast feeding, pregnant, or planning to become pregnant
- Any skin condition of the face other than acne vulgaris
- Two or more active nodular lesions
- Excessive facial hair that would interfere with the evaluation of safety or with the diagnosis or assessment of acne vulgaris
- Use of tanning beds/booths, or excessive sun exposure
- Use of over-the-counter topical medications for treatment of acne vulgaris on the face within 14 days of baseline
- 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
- Initiation of hormonal therapy or dose change to hormonal therapy within 12 weeks prior to baseline.
- Use of androgen receptor blockers (eg, spironolactone, flutamide) within 12 weeks prior to baseline
- 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
- Facial procedures (eg, microdermabrasion, chemical or laser peel) within 8 weeks prior to baseline
- Photodynamic therapy within 12 weeks prior to baseline
- Any other reason that would make the subject, in the opinion of the Investigator or Sponsor, unsuitable for the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
Kirk Barber Research
Calgary, Alberta, T2G 1B1, Canada
Institute for Skin Advancement
Calgary, Alberta, T3A 2N1, Canada
Stratica Medical Inc.
Edmonton, Alberta, T5K 1X3, Canada
Dr. Chih-ho Hong Medical Inc.
Surrey, British Columbia, V3R 6A7, Canada
Carruthers & Humphrey Clinical Research
Vancouver, British Columbia, V5Z 4E1, Canada
Pacific Dermaesthetics
Vancouver, British Columbia, V6E 4M3, Canada
Toole Dermatology Research
Winnipeg, Manitoba, R3C 1R4, Canada
Clinique Médicale Nepisiguit
Bathurst, New Brunswick, E2A 4Z9, Canada
SimcoDerm Medical and Surgical Dermatology Center
Barrie, Ontario, L4M 7G1, Canada
Lynderm Research Inc
Markham, Ontario, L3P 1X2, Canada
DermEdge Research
Mississauga, Ontario, L5H 1G9, Canada
Research by ICLS
Oakville, Ontario, L6J 7W5, Canada
York Dermatology Center
Richmond Hill, Ontario, L4C 9M7, Canada
Bayview North Dermatology Clinic
Toronto, Ontario, M2M 4J5, Canada
G. Daniel Schachter Medicine Professional Corporation
Toronto, Ontario, M5S 3B4, Canada
K. Papp Clinical Research Inc
Waterloo, Ontario, N2J 1C4, Canada
Windsor Clinical Research Inc.
Windsor, Ontario, N8W 5L7, Canada
Innovaderm Research Inc.
Montreal, Quebec, H2K4L5, Canada
Dre Angélique Gagné-Henley M.D. Inc
Saint-Jérôme, Quebec, J7Z 3B8, Canada
Siena Medical Research Corporation
Westmount, Quebec, H3Z 2S6, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Xenon Pharmaceuticals Inc.
Xenon Pharmaceuticals Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 12, 2016
First Posted
January 14, 2016
Study Start
September 17, 2015
Primary Completion
February 16, 2017
Study Completion
March 17, 2017
Last Updated
January 22, 2019
Record last verified: 2019-01