Acne Vulgaris
Conditions
Brief summary
This is a safety, tolerability and pharmacokinetics study of AGN-190168 in subjects with acne vulgaris.
Interventions
DRUGAGN-190168 Formulation 1
AGN-190168 Formulation 1 applied topically to the face, neck, upper chest, upper back, and shoulders once daily for 29 days.
DRUGAGN-190168 Formulation 2
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% applied topically to the face, neck, upper chest, upper back, and shoulders once daily for 29 days.
Tazarotene cream 0.1% cream applied topically to the face, neck, upper chest, upper back, and shoulders once daily for 29 days.
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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 |
Countries
United States
Outcome results
None listed