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

Condition(s) targeted: Acne Vulgaris

Intervention: AGN-190168 Formulation 1 (Drug); AGN-190168 Formulation 2 (Drug); tazarotene gel 0.1% (Drug); tazarotene cream 0.1% (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Allergan

Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Allergan

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

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Basic Science

Primary outcome:

Maximum Plasma Level (Cmax) of AGN-190168

Maximum Plasma Level (Cmax) of AGN-190168 Metabolite

Local Dermal Tolerability as Assessed by the Subject Using a 4-Point Scale

Local Dermal Tolerability as Assessed by the Investigator Using a 4-Point Scale

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.

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

College Station, Texas, United States

Starting date: August 2014
Last updated: April 28, 2015