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Trial record 65 of 164 for:    acne AND Vehicle

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

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ClinicalTrials.gov Identifier: NCT02656043
Recruitment Status : Completed
First Posted : January 14, 2016
Last Update Posted : January 21, 2019
Sponsor:
Information provided by (Responsible Party):
Xenon Pharmaceuticals Inc.

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.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: XPF-005 Drug: Placebo Phase 1 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).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 213 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : September 17, 2015
Actual Primary Completion Date : February 16, 2017
Actual Study Completion Date : March 17, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

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

Placebo Comparator: Vehicle gel
Placebo: XPF-005 Vehicle Gel
Drug: Placebo



Primary Outcome Measures :
  1. Change from Baseline in acne lesion count [ Time Frame: Week 12 ]

Secondary Outcome Measures :
  1. Change from Baseline in acne lesion count [ Time Frame: Week 4 and 8 ]
  2. Change from Baseline in Investigator Global Assessment (IGA) [ Time Frame: Week 4, 8 and 12 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02656043


Locations
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Canada, Alberta
Kirk Barber Research
Calgary, Alberta, Canada, T2G 1B1
Institute for Skin Advancement
Calgary, Alberta, Canada, T3A 2N1
Stratica Medical Inc.
Edmonton, Alberta, Canada, T5K 1X3
Canada, British Columbia
Dr. Chih-ho Hong Medical Inc.
Surrey, British Columbia, Canada, V3R 6A7
Carruthers & Humphrey Clinical Research
Vancouver, British Columbia, Canada, V5Z 4E1
Pacific Dermaesthetics
Vancouver, British Columbia, Canada, V6E 4M3
Canada, Manitoba
Toole Dermatology Research
Winnipeg, Manitoba, Canada, R3C 1R4
Canada, New Brunswick
Clinique Médicale Nepisiguit
Bathurst, New Brunswick, Canada, E2A 4Z9
Canada, Ontario
SimcoDerm Medical and Surgical Dermatology Center
Barrie, Ontario, Canada, L4M 7G1
Lynderm Research Inc
Markham, Ontario, Canada, L3P 1X2
DermEdge Research
Mississauga, Ontario, Canada, L5H 1G9
Research by ICLS
Oakville, Ontario, Canada, L6J 7W5
York Dermatology Center
Richmond Hill, Ontario, Canada, L4C 9M7
Bayview North Dermatology Clinic
Toronto, Ontario, Canada, M2M 4J5
G. Daniel Schachter Medicine Professional Corporation
Toronto, Ontario, Canada, M5S 3B4
K. Papp Clinical Research Inc
Waterloo, Ontario, Canada, N2J 1C4
Windsor Clinical Research Inc.
Windsor, Ontario, Canada, N8W 5L7
Canada, Quebec
Innovaderm Research Inc.
Montréal, Quebec, Canada, H2K4L5
Dre Angélique Gagné-Henley M.D. Inc
Saint-Jérôme, Quebec, Canada, J7Z 3B8
Siena Medical Research Corporation
Westmount, Quebec, Canada, H3Z 2S6
Sponsors and Collaborators
Xenon Pharmaceuticals Inc.
Investigators
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Study Director: Xenon Pharmaceuticals Inc. Xenon Pharmaceuticals Inc.

Additional Information:
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Responsible Party: Xenon Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT02656043     History of Changes
Other Study ID Numbers: XPF-005-101
First Posted: January 14, 2016    Key Record Dates
Last Update Posted: January 21, 2019
Last Verified: January 2019
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases