Safety, Tolerability and Pharmacokinetics of AGN-190168 in Subjects With Acne Vulgaris
Overview
- Phase
- Phase 1
- Intervention
- AGN-190168 Formulation 1
- Conditions
- Acne Vulgaris
- Sponsor
- Allergan
- Enrollment
- 78
- Primary Endpoint
- Maximum Plasma Level (Cmax) of AGN-190168 Metabolite
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
This is a safety, tolerability and pharmacokinetics study of AGN-190168 in subjects with acne vulgaris.
Investigators
Eligibility Criteria
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
Arms & Interventions
AGN-190168 Formulation 1
AGN-190168 Formulation 1 applied topically to the face, neck, upper chest, upper back, and shoulders once daily for 29 days.
Intervention: AGN-190168 Formulation 1
AGN-190168 Formulation 2
AGN-190168 Formulation 2 applied topically to the face, neck, upper chest, upper back, and shoulders once daily for 29 days.
Intervention: AGN-190168 Formulation 2
TAZORAC® 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.
Intervention: tazarotene gel 0.1%
TAZORAC® 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.
Intervention: tazarotene cream 0.1%
Outcomes
Primary Outcomes
Maximum Plasma Level (Cmax) of AGN-190168 Metabolite
Time Frame: Day 29
Local Dermal Tolerability as Assessed by the Investigator Using a 4-Point Scale
Time Frame: Day 29
Maximum Plasma Level (Cmax) of AGN-190168
Time Frame: Day 29
Local Dermal Tolerability as Assessed by the Subject Using a 4-Point Scale
Time Frame: Day 29