search
Back to results

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

Primary Purpose

Acne Vulgaris

Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
XPF-005
Placebo
Sponsored by
Xenon Pharmaceuticals Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Vulgaris

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Kirk Barber Research
  • Institute for Skin Advancement
  • Stratica Medical Inc.
  • Dr. Chih-ho Hong Medical Inc.
  • Carruthers & Humphrey Clinical Research
  • Pacific Dermaesthetics
  • Toole Dermatology Research
  • Clinique Médicale Nepisiguit
  • SimcoDerm Medical and Surgical Dermatology Center
  • Lynderm Research Inc
  • DermEdge Research
  • Research by ICLS
  • York Dermatology Center
  • Bayview North Dermatology Clinic
  • G. Daniel Schachter Medicine Professional Corporation
  • K. Papp Clinical Research Inc
  • Windsor Clinical Research Inc.
  • Innovaderm Research Inc.
  • Dre Angélique Gagné-Henley M.D. Inc
  • Siena Medical Research Corporation

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

XPF-005

Vehicle gel

Arm Description

Active treatment: XPF-005 Gel

Placebo: XPF-005 Vehicle Gel

Outcomes

Primary Outcome Measures

Change from Baseline in acne lesion count

Secondary Outcome Measures

Change from Baseline in acne lesion count
Change from Baseline in Investigator Global Assessment (IGA)

Full Information

First Posted
January 12, 2016
Last Updated
January 17, 2019
Sponsor
Xenon Pharmaceuticals Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT02656043
Brief Title
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

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
September 17, 2015 (Actual)
Primary Completion Date
February 16, 2017 (Actual)
Study Completion Date
March 17, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xenon Pharmaceuticals Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
213 (Actual)

8. Arms, Groups, and Interventions

Arm Title
XPF-005
Arm Type
Active Comparator
Arm Description
Active treatment: XPF-005 Gel
Arm Title
Vehicle gel
Arm Type
Placebo Comparator
Arm Description
Placebo: XPF-005 Vehicle Gel
Intervention Type
Drug
Intervention Name(s)
XPF-005
Intervention Description
Comparison of active treatment XPF-005 topical gel against Placebo (XPF-005 Vehicle Gel) applied to face for acne vulgaris.
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change from Baseline in acne lesion count
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Change from Baseline in acne lesion count
Time Frame
Week 4 and 8
Title
Change from Baseline in Investigator Global Assessment (IGA)
Time Frame
Week 4, 8 and 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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: 25 to 75 inflammatory lesions, 20 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 Key Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xenon Pharmaceuticals Inc.
Organizational Affiliation
Xenon Pharmaceuticals Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Kirk Barber Research
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2G 1B1
Country
Canada
Facility Name
Institute for Skin Advancement
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3A 2N1
Country
Canada
Facility Name
Stratica Medical Inc.
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5K 1X3
Country
Canada
Facility Name
Dr. Chih-ho Hong Medical Inc.
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3R 6A7
Country
Canada
Facility Name
Carruthers & Humphrey Clinical Research
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E1
Country
Canada
Facility Name
Pacific Dermaesthetics
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6E 4M3
Country
Canada
Facility Name
Toole Dermatology Research
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3C 1R4
Country
Canada
Facility Name
Clinique Médicale Nepisiguit
City
Bathurst
State/Province
New Brunswick
ZIP/Postal Code
E2A 4Z9
Country
Canada
Facility Name
SimcoDerm Medical and Surgical Dermatology Center
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 7G1
Country
Canada
Facility Name
Lynderm Research Inc
City
Markham
State/Province
Ontario
ZIP/Postal Code
L3P 1X2
Country
Canada
Facility Name
DermEdge Research
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5H 1G9
Country
Canada
Facility Name
Research by ICLS
City
Oakville
State/Province
Ontario
ZIP/Postal Code
L6J 7W5
Country
Canada
Facility Name
York Dermatology Center
City
Richmond Hill
State/Province
Ontario
ZIP/Postal Code
L4C 9M7
Country
Canada
Facility Name
Bayview North Dermatology Clinic
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M2M 4J5
Country
Canada
Facility Name
G. Daniel Schachter Medicine Professional Corporation
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5S 3B4
Country
Canada
Facility Name
K. Papp Clinical Research Inc
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2J 1C4
Country
Canada
Facility Name
Windsor Clinical Research Inc.
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8W 5L7
Country
Canada
Facility Name
Innovaderm Research Inc.
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2K4L5
Country
Canada
Facility Name
Dre Angélique Gagné-Henley M.D. Inc
City
Saint-Jérôme
State/Province
Quebec
ZIP/Postal Code
J7Z 3B8
Country
Canada
Facility Name
Siena Medical Research Corporation
City
Westmount
State/Province
Quebec
ZIP/Postal Code
H3Z 2S6
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs