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

X

Xenon Pharmaceuticals

Status and phase

Completed
Phase 2
Phase 1

Conditions

Acne Vulgaris

Treatments

Drug: Placebo
Drug: XPF-005

Study type

Interventional

Funder types

Industry

Identifiers

NCT02656043
XPF-005-101

Details and patient eligibility

About

Phase 1/2 study enrolling up to 60 healthy volunteers in Phase 1 followed by approximately 150 subjects with acne vulgaris in Phase 2.

Full 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).

Enrollment

213 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

213 participants in 2 patient groups, including a placebo group

XPF-005
Active Comparator group
Description:
Active treatment: XPF-005 Gel
Treatment:
Drug: XPF-005
Vehicle gel
Placebo Comparator group
Description:
Placebo: XPF-005 Vehicle Gel
Treatment:
Drug: Placebo

Trial contacts and locations

20

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Data sourced from clinicaltrials.gov

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