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

Phase 1

Completed

• Conditions: Acne Vulgaris
• Interventions: Drug: tazarotene gel 0.1%; Drug: AGN-190168 Formulation 2; Drug: AGN-190168 Formulation 1; Drug: tazarotene cream 0.1%

• Registration Number: NCT02218034
• Lead Sponsor: Allergan

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2014-08-14
• Study First Submitted QC: 2014-08-14
• Study First Posted: 2014-08-15
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-28
• Last Update Posted: 2015-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TAZORAC® Gel 0.1%	tazarotene gel 0.1%	TAZORAC® Gel 0.1% (tazarotene gel 0.1%) applied topically to the face, neck, upper chest, upper back, and shoulders once daily for 29 days.
AGN-190168 Formulation 2	AGN-190168 Formulation 2	AGN-190168 Formulation 2 applied topically to the face, neck, upper chest, upper back, and shoulders once daily for 29 days.
AGN-190168 Formulation 1	AGN-190168 Formulation 1	AGN-190168 Formulation 1 applied topically to the face, neck, upper chest, upper back, and shoulders once daily for 29 days.
TAZORAC® Cream 0.1%	tazarotene cream 0.1%	TAZORAC® Cream 0.1% (tazarotene cream 0.1%) applied topically to the face, neck, upper chest, upper back, and shoulders once daily for 29 days.

Primary Outcome Measures

Name	Time	Method
Maximum Plasma Level (Cmax) of AGN-190168 Metabolite	Day 29
Local Dermal Tolerability as Assessed by the Investigator Using a 4-Point Scale	Day 29
Maximum Plasma Level (Cmax) of AGN-190168	Day 29
Local Dermal Tolerability as Assessed by the Subject Using a 4-Point Scale	Day 29