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

Acne Vulgaris Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02656043
• Other study ID #: XPF-005-101
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: September 17, 2015
• Est. completion date: March 17, 2017

Study information

• Verified date: January 2019
• Source: Xenon Pharmaceuticals Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 213
• Est. completion date: March 17, 2017
• Est. primary completion date: February 16, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

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

Locations

Country	Name	City	State
Canada	SimcoDerm Medical and Surgical Dermatology Center	Barrie	Ontario
Canada	Clinique Médicale Nepisiguit	Bathurst	New Brunswick
Canada	Institute for Skin Advancement	Calgary	Alberta
Canada	Kirk Barber Research	Calgary	Alberta
Canada	Stratica Medical Inc.	Edmonton	Alberta
Canada	Lynderm Research Inc	Markham	Ontario
Canada	DermEdge Research	Mississauga	Ontario
Canada	Innovaderm Research Inc.	Montréal	Quebec
Canada	Research by ICLS	Oakville	Ontario
Canada	York Dermatology Center	Richmond Hill	Ontario
Canada	Dre Angélique Gagné-Henley M.D. Inc	Saint-Jérôme	Quebec
Canada	Dr. Chih-ho Hong Medical Inc.	Surrey	British Columbia
Canada	Bayview North Dermatology Clinic	Toronto	Ontario
Canada	G. Daniel Schachter Medicine Professional Corporation	Toronto	Ontario
Canada	Carruthers & Humphrey Clinical Research	Vancouver	British Columbia
Canada	Pacific Dermaesthetics	Vancouver	British Columbia
Canada	K. Papp Clinical Research Inc	Waterloo	Ontario
Canada	Siena Medical Research Corporation	Westmount	Quebec
Canada	Windsor Clinical Research Inc.	Windsor	Ontario
Canada	Toole Dermatology Research	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
Xenon Pharmaceuticals Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in acne lesion count		Week 12
Secondary	Change from Baseline in acne lesion count		Week 4 and 8
Secondary	Change from Baseline in Investigator Global Assessment (IGA)		Week 4, 8 and 12

External Links

•   Study information and participation