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

Allergan

Status and phase: Completed; Phase 1

Conditions: Acne Vulgaris

Treatments: Drug: AGN-190168 Formulation 2; Drug: AGN-190168 Formulation 1; Drug: tazarotene gel 0.1%; Drug: tazarotene cream 0.1%

Study type: Interventional

Funder types: Industry

Identifiers

NCT02218034

190168-069

Details and patient eligibility

About

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

Enrollment: 78 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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78 participants in 4 patient groups

AGN-190168 Formulation 1

Experimental group

Description:

AGN-190168 Formulation 1 applied topically to the face, neck, upper chest, upper back, and shoulders once daily for 29 days.

Treatment:

Drug: AGN-190168 Formulation 1

AGN-190168 Formulation 2

Experimental group

Description:

AGN-190168 Formulation 2 applied topically to the face, neck, upper chest, upper back, and shoulders once daily for 29 days.

Treatment:

Drug: AGN-190168 Formulation 2

TAZORAC® Gel 0.1%

Active Comparator group

Description:

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.

Treatment:

Drug: tazarotene gel 0.1%

TAZORAC® Cream 0.1%

Active Comparator group

Description:

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.

Treatment:

Drug: tazarotene cream 0.1%