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

NCT ID: NCT02656043

Last Updated: 2019-01-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 213 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-17
• Study Completion Date: 2017-03-17

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).

Conditions

Acne Vulgaris

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

XPF-005

Active treatment: XPF-005 Gel

Group Type: ACTIVE_COMPARATOR

XPF-005

Intervention Type: DRUG

Comparison of active treatment XPF-005 topical gel against Placebo (XPF-005 Vehicle Gel) applied to face for acne vulgaris.

Vehicle gel

Placebo: XPF-005 Vehicle Gel

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

XPF-005

Comparison of active treatment XPF-005 topical gel against Placebo (XPF-005 Vehicle Gel) applied to face for acne vulgaris.

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Xenon Pharmaceuticals Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xenon Pharmaceuticals Inc.

Role: STUDY_DIRECTOR

Xenon Pharmaceuticals Inc.

Locations

Kirk Barber Research

Calgary, Alberta, Canada

Institute for Skin Advancement

Calgary, Alberta, Canada

Stratica Medical Inc.

Edmonton, Alberta, Canada

Dr. Chih-ho Hong Medical Inc.

Surrey, British Columbia, Canada

Carruthers & Humphrey Clinical Research

Vancouver, British Columbia, Canada

Pacific Dermaesthetics

Vancouver, British Columbia, Canada

Toole Dermatology Research

Winnipeg, Manitoba, Canada

Clinique Médicale Nepisiguit

Bathurst, New Brunswick, Canada

SimcoDerm Medical and Surgical Dermatology Center

Barrie, Ontario, Canada

Lynderm Research Inc

Markham, Ontario, Canada

DermEdge Research

Mississauga, Ontario, Canada

Research by ICLS

Oakville, Ontario, Canada

York Dermatology Center

Richmond Hill, Ontario, Canada

Bayview North Dermatology Clinic

Toronto, Ontario, Canada

G. Daniel Schachter Medicine Professional Corporation

Toronto, Ontario, Canada

K. Papp Clinical Research Inc

Waterloo, Ontario, Canada

Windsor Clinical Research Inc.

Windsor, Ontario, Canada

Innovaderm Research Inc.

Montreal, Quebec, Canada

Dre Angélique Gagné-Henley M.D. Inc

Saint-Jérôme, Quebec, Canada

Siena Medical Research Corporation

Westmount, Quebec, Canada

Countries

Canada

Other Identifiers

XPF-005-101

Identifier Type: -

Identifier Source: org_study_id