Acne VulgarisPhase 1/2NCT02656043
A Safety, Tolerability, Efficacy and Exposure Study of XEN801 Topical Gel
A Phase 1/2 study testing XPF-005 in people with Acne Vulgaris, run by Xenon Pharmaceuticals Inc. at 20 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- XPF-005
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 213 participants
- Where
- 20 sitesCanada
- Study dates
- 17 Sep 2015to 17 Mar 2017
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged between 18 and 50, inclusive
- Male or female, agree to comply with contraceptive requirements
- Signed Informed Consent Form
- 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
- 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
Who cannot join
- Known sensitivity to any topical or dermal product, including alcohol
- Female who is breast feeding, pregnant, or planning to become pregnant
- Any skin condition of the face other than acne vulgaris
- Two or more active nodular lesions
- Excessive facial hair that would interfere with the evaluation of safety or with the diagnosis or assessment of acne vulgaris
- Use of tanning beds/booths, or excessive sun exposure
Show all 14Show fewer
- Use of over-the-counter topical medications for treatment of acne vulgaris on the face within 14 days of baseline
- 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
- Initiation of hormonal therapy or dose change to hormonal therapy within 12 weeks prior to baseline.
- Use of androgen receptor blockers (eg, spironolactone, flutamide) within 12 weeks prior to baseline
- 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
- Facial procedures (eg, microdermabrasion, chemical or laser peel) within 8 weeks prior to baseline
- Photodynamic therapy within 12 weeks prior to baseline
- Any other reason that would make the subject, in the opinion of the Investigator or Sponsor, unsuitable for the study
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
Canada20 sites
SimcoDerm Medical and Surgical Dermatology Center
Barrie, Ontario, L4M 7G1
Clinique Médicale Nepisiguit
Bathurst, New Brunswick, E2A 4Z9
Kirk Barber Research
Calgary, Alberta, T2G 1B1
Institute for Skin Advancement
Calgary, Alberta, T3A 2N1
Stratica Medical Inc.
Edmonton, Alberta, T5K 1X3
Lynderm Research Inc
Markham, Ontario, L3P 1X2
DermEdge Research
Mississauga, Ontario, L5H 1G9
Innovaderm Research Inc.
Montreal, Quebec, H2K4L5
Research by ICLS
Oakville, Ontario, L6J 7W5
York Dermatology Center
Richmond Hill, Ontario, L4C 9M7
Dre Angélique Gagné-Henley M.D. Inc
Saint-Jérôme, Quebec, J7Z 3B8
Dr. Chih-ho Hong Medical Inc.
Surrey, British Columbia, V3R 6A7
Bayview North Dermatology Clinic
Toronto, Ontario, M2M 4J5
G. Daniel Schachter Medicine Professional Corporation
Toronto, Ontario, M5S 3B4
Carruthers & Humphrey Clinical Research
Vancouver, British Columbia, V5Z 4E1
Pacific Dermaesthetics
Vancouver, British Columbia, V6E 4M3
K. Papp Clinical Research Inc
Waterloo, Ontario, N2J 1C4
Siena Medical Research Corporation
Westmount, Quebec, H3Z 2S6
Windsor Clinical Research Inc.
Windsor, Ontario, N8W 5L7
Toole Dermatology Research
Winnipeg, Manitoba, R3C 1R4
About this study
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
Phase 1/2 study enrolling up to 60 healthy volunteers in Phase 1 followed by approximately 150 subjects with acne vulgaris in Phase 2.
Read the 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
- Being tested
- XPF-005, Placebo
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XPF-005Drug
Comparison of active treatment XPF-005 topical gel against Placebo (XPF-005 Vehicle Gel) applied to face for acne vulgaris.
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| XPF-005 | Active comparator | Active treatment: XPF-005 Gel Receives: Drug: XPF-005 |
| Vehicle gel | Placebo comparator | Placebo: XPF-005 Vehicle Gel Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in acne lesion count
Measured: Week 12
Secondary outcomes (2)
Change from Baseline in acne lesion count
Measured: Week 4 and 8
Change from Baseline in Investigator Global Assessment (IGA)
Measured: Week 4, 8 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2016 (estimated)
- Study start17 Sep 2015
- Primary completion16 Feb 2017
- Study completion17 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 213 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xenon Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xenon Pharmaceuticals Inc., Study director, Xenon Pharmaceuticals Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02656043
- Sponsor's protocol ID
- XPF-005-101
- Status last verified
- Jan 2019
- First submitted
- 12 Jan 2016
- Last updated
- 22 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02656043
- Acronym / sponsor ID
- XPF-005-101
- Conditions
- Acne Vulgaris
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 213 participants (actual)
- Lead sponsor
- Xenon Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Sep 2015 (actual)
- Primary completion
- 16 Feb 2017 (actual)
- Study completion
- 17 Mar 2017 (actual)
- First posted
- 14 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| XPF-005 | Active comparator | Drug: XPF-005Active treatment: XPF-005 Gel |
| Vehicle gel | Placebo comparator | Drug: PlaceboPlacebo: XPF-005 Vehicle Gel |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Aged between 18 and 50, inclusive
- Male or female, agree to comply with contraceptive requirements
- Signed Informed Consent Form
- Clinical diagnosis of facial acne vulgaris defined as:
- 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 (14 listed)
- Known sensitivity to any topical or dermal product, including alcohol
- Female who is breast feeding, pregnant, or planning to become pregnant
- Any skin condition of the face other than acne vulgaris
- Two or more active nodular lesions
- Excessive facial hair that would interfere with the evaluation of safety or with the diagnosis or assessment of acne vulgaris
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XPF-005Comparison of active treatment XPF-005 topical gel against Placebo (XPF-005 Vehicle Gel) applied to face for acne vulgaris. | Drug | XPF-005 |
| Placebo | Drug | Vehicle gel |
Primary outcome
Change from Baseline in acne lesion count
Time frame: Week 12
2 secondary outcomes
Change from Baseline in acne lesion count
Time frame: Week 4 and 8
Change from Baseline in Investigator Global Assessment (IGA)
Time frame: Week 4, 8 and 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xenon Pharmaceuticals Inc. study director
Xenon Pharmaceuticals Inc.
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing XPF-005 in people with Acne Vulgaris, run by Xenon Pharmaceuticals Inc. at 20 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in acne lesion count (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2019.