Safety, Tolerability and Pharmacokinetics of AGN-190168 in Subjects With Acne Vulgaris

Study Overview
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Brief Summary
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This is a safety, tolerability and pharmacokinetics study of AGN-190168 in subjects with acne vulgaris.

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Drug: AGN-190168 Formulation 1
* Drug: AGN-190168 Formulation 2
* Drug: tazarotene gel 0.1%
* Drug: tazarotene cream 0.1%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AGN-190168 Formulation 1<br>AGN-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<br>* AGN-190168 Formulation 1 applied topically to the face, neck, upper chest, upper back, and shoulders once daily for 29 days.<br>|
| Experimental: AGN-190168 Formulation 2<br>AGN-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<br>* AGN-190168 Formulation 2 applied topically to the face, neck, upper chest, upper back, and shoulders once daily for 29 days.<br>|
| Active Comparator: TAZORAC® Gel 0.1%<br>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: tazarotene gel 0.1%<br>* Tazarotene gel 0.1% applied topically to the face, neck, upper chest, upper back, and shoulders once daily for 29 days.<br>* Other names: TAZORAC® Gel 0.1%;|
| Active Comparator: TAZORAC® Cream 0.1%<br>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. | Drug: tazarotene cream 0.1%<br>* Tazarotene cream 0.1% cream applied topically to the face, neck, upper chest, upper back, and shoulders once daily for 29 days.<br>* Other names: TAZORAC® Cream 0.1%;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Plasma Level (Cmax) of AGN-190168 |  | Day 29 | 
| Maximum Plasma Level (Cmax) of AGN-190168 Metabolite |  | Day 29 | 
| Local Dermal Tolerability as Assessed by the Subject Using a 4-Point Scale |  | Day 29 | 
| Local Dermal Tolerability as Assessed by the Investigator Using a 4-Point Scale |  | Day 29 |