Status:
COMPLETED
Safety, Tolerability and Pharmacokinetics of AGN-190168 in Subjects With Acne Vulgaris
Lead Sponsor:
Allergan
Conditions:
Acne Vulgaris
Eligibility:
All Genders
12+ years
Phase:
PHASE1
Brief Summary
This is a safety, tolerability and pharmacokinetics study of AGN-190168 in subjects with acne vulgaris.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT02218034
Start Date
August 1 2014
End Date
March 1 2015
Last Update
April 30 2015
Active Locations (1)
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1
College Station, Texas, United States