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

• Status: Completed
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Allergan
• Treatments: Nicotinic Acids; Tazarotene

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