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



Status:Completed
Conditions:Acne, Acne, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:12 - Any
Updated:2/8/2015
Start Date:August 2014
End Date:March 2015
Contact:Allergan Inc.
Email:clinicaltrials@allergan.com

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


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
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