Acne VulgarisPhase 1NCT02218034
Safety, Tolerability and Pharmacokinetics of AGN-190168 in Subjects With Acne Vulgaris
A Phase 1 study testing AGN-190168 Formulation 1, AGN-190168 Formulation 2 and tazarotene gel 0.1% in people with Acne Vulgaris, run by Allergan at 1 site in United States.
Trial summary
This is a safety, tolerability and pharmacokinetics study of AGN-190168 in subjects with acne vulgaris. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- AGN-190168 Formulation 1, AGN-190168 Formulation 2 and tazarotene gel 0.1%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Mar 2015
- Phase
- Phase 1
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of acne vulgaris on the face
- No tobacco use for the past 30 days, and willing to refrain from nicotine use during the study
- Willing to avoid excessive or prolonged exposure of the treated skin to ultraviolet light (eg, sunlight, tanning beds) and extremes in weather, such as wind or cold, throughout the study
- If male, willing to maintain routine shaving regimen for the duration of the study and avoid shaving 12 hours prior to specified visits
- Females of childbearing potential must use a reliable method of contraception
Who cannot join
- Use of phototherapy devices (eg, ClearLight™) and adhesive cleansing strips (eg, Ponds® and Biore®), as well as cosmetic procedures (eg, facials, peeling, and comedone extraction) in the area to be treated in the past 1 week
- Use of topical anti-inflammatory drugs, salicylic acid (eg, Clearasil® and Clean \& Clear®), corticosteroids, antibiotics, antibacterials (including benzoyl peroxide-containing products [eg, benzamycin]), retinoids, and other topical acne treatments (eg, photodynamic therapy, laser therapy, and medicated soaps) in the area to be treated in the past 2 weeks
- Ability to abstain from caffeine-containing products on the dates instructed
Trial locations and contacts
1 site in 1 country.
About this study
This is a safety, tolerability and pharmacokinetics study of AGN-190168 in subjects with acne vulgaris.
- Conditions
- Acne Vulgaris
- Being tested
- AGN-190168 Formulation 1, AGN-190168 Formulation 2, tazarotene gel 0.1%, tazarotene cream 0.1%
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AGN-190168 Formulation 1Drug
AGN-190168 Formulation 1 applied topically to the face, neck, upper chest, upper back, and shoulders once daily for 29 days.
AGN-190168 Formulation 2Drug
AGN-190168 Formulation 2 applied topically to the face, neck, upper chest, upper back, and shoulders once daily for 29 days.
tazarotene gel 0.1%Drug
Also called TAZORAC® Gel 0.1%
Tazarotene gel 0.1% applied topically to the face, neck, upper chest, upper back, and shoulders once daily for 29 days.
tazarotene cream 0.1%Drug
Also called TAZORAC® Cream 0.1%
Tazarotene cream 0.1% cream applied topically to the face, neck, upper chest, upper back, and shoulders once daily for 29 days.
| Study group | Role | What they receive |
|---|---|---|
| AGN-190168 Formulation 1 | Experimental | AGN-190168 Formulation 1 applied topically to the face, neck, upper chest, upper back, and shoulders once daily for 29 days. Receives: Drug: AGN-190168 Formulation 1 |
| AGN-190168 Formulation 2 | Experimental | AGN-190168 Formulation 2 applied topically to the face, neck, upper chest, upper back, and shoulders once daily for 29 days. Receives: Drug: AGN-190168 Formulation 2 |
| TAZORAC® Gel 0.1% | Active comparator | TAZORAC® Gel 0.1% (tazarotene gel 0.1%) applied topically to the face, neck, upper chest, upper back, and shoulders once daily for 29 days. Receives: Drug: tazarotene gel 0.1% |
| TAZORAC® Cream 0.1% | Active comparator | TAZORAC® Cream 0.1% (tazarotene cream 0.1%) applied topically to the face, neck, upper chest, upper back, and shoulders once daily for 29 days. Receives: Drug: tazarotene cream 0.1% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plasma Level (Cmax) of AGN-190168
Measured: Day 29
Maximum Plasma Level (Cmax) of AGN-190168 Metabolite
Measured: Day 29
Local Dermal Tolerability as Assessed by the Subject Using a 4-Point Scale
Measured: Day 29
Local Dermal Tolerability as Assessed by the Investigator Using a 4-Point Scale
Measured: Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionMar 2015
- Study completionMar 2015
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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02218034
- Sponsor's protocol ID
- 190168-069
- Status last verified
- Apr 2015
- First submitted
- 14 Aug 2014
- Last updated
- 30 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability and Pharmacokinetics of AGN-190168 in Subjects With Acne Vulgaris
- ClinicalTrials.gov ID
- NCT02218034
- Acronym / sponsor ID
- 190168-069
- Conditions
- Acne Vulgaris
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- Aug 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 15 Aug 2014 (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.
This is a safety, tolerability and pharmacokinetics study of AGN-190168 in subjects with acne vulgaris.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| AGN-190168 Formulation 1 | Experimental | Drug: AGN-190168 Formulation 1AGN-190168 Formulation 1 applied topically to the face, neck, upper chest, upper back, and shoulders once daily for 29 days. |
| AGN-190168 Formulation 2 | Experimental | Drug: AGN-190168 Formulation 2AGN-190168 Formulation 2 applied topically to the face, neck, upper chest, upper back, and shoulders once daily for 29 days. |
| TAZORAC® Gel 0.1% | Active comparator | Drug: tazarotene gel 0.1%TAZORAC® Gel 0.1% (tazarotene gel 0.1%) applied topically to the face, neck, upper chest, upper back, and shoulders once daily for 29 days. |
| TAZORAC® Cream 0.1% | Active comparator | Drug: tazarotene cream 0.1%TAZORAC® Cream 0.1% (tazarotene cream 0.1%) applied topically to the face, neck, upper chest, upper back, and shoulders once daily for 29 days. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of acne vulgaris on the face
- No tobacco use for the past 30 days, and willing to refrain from nicotine use during the study
- Willing to avoid excessive or prolonged exposure of the treated skin to ultraviolet light (eg, sunlight, tanning beds) and extremes in weather, such as wind or cold, throughout the study
- If male, willing to maintain routine shaving regimen for the duration of the study and avoid shaving 12 hours prior to specified visits
- Females of childbearing potential must use a reliable method of contraception
Key exclusion criteria (3 listed)
- Use of phototherapy devices (eg, ClearLight™) and adhesive cleansing strips (eg, Ponds® and Biore®), as well as cosmetic procedures (eg, facials, peeling, and comedone extraction) in the area to be treated in the past 1 week
- Use of topical anti-inflammatory drugs, salicylic acid (eg, Clearasil® and Clean \& Clear®), corticosteroids, antibiotics, antibacterials (including benzoyl peroxide-containing products [eg, benzamycin]), retinoids, and other topical acne treatments (eg, photodynamic therapy, laser therapy, and medicated soaps) in the area to be treated in the past 2 weeks
- Ability to abstain from caffeine-containing products on the dates instructed
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 |
|---|---|---|
| AGN-190168 Formulation 1AGN-190168 Formulation 1 applied topically to the face, neck, upper chest, upper back, and shoulders once daily for 29 days. | Drug | AGN-190168 Formulation 1 |
| AGN-190168 Formulation 2AGN-190168 Formulation 2 applied topically to the face, neck, upper chest, upper back, and shoulders once daily for 29 days. | Drug | AGN-190168 Formulation 2 |
| tazarotene gel 0.1%Also: TAZORAC® Gel 0.1%Tazarotene gel 0.1% applied topically to the face, neck, upper chest, upper back, and shoulders once daily for 29 days. | Drug | TAZORAC® Gel 0.1% |
| tazarotene cream 0.1%Also: TAZORAC® Cream 0.1%Tazarotene cream 0.1% cream applied topically to the face, neck, upper chest, upper back, and shoulders once daily for 29 days. | Drug | TAZORAC® Cream 0.1% |
Primary outcome
Maximum Plasma Level (Cmax) of AGN-190168
Time frame: Day 29
Maximum Plasma Level (Cmax) of AGN-190168 Metabolite
Time frame: Day 29
Local Dermal Tolerability as Assessed by the Subject Using a 4-Point Scale
Time frame: Day 29
Local Dermal Tolerability as Assessed by the Investigator Using a 4-Point Scale
Time frame: Day 29
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 30 Apr 2015.
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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.
Medical Director study director
Allergan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AGN-190168 Formulation 1, AGN-190168 Formulation 2 and tazarotene gel 0.1% in people with Acne Vulgaris, run by Allergan at 1 site in United States.
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 5 inclusion and 3 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 30 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
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?
Maximum Plasma Level (Cmax) of AGN-190168 (time frame: Day 29). The study lists 4 primary outcomes in all. 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 30 Apr 2015.