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

• Status: Completed
• Trial end date: 2017-03-17
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Xenon Pharmaceuticals Inc.

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