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

NCT02218034 | Completed Phase 1

• 1 other identifier: 190168-069
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (4)

• Maximum Plasma Level (Cmax) of AGN-190168

  Day 29

• Maximum Plasma Level (Cmax) of AGN-190168 Metabolite

  Day 29

• Local Dermal Tolerability as Assessed by the Subject Using a 4-Point Scale

  Day 29

• Local Dermal Tolerability as Assessed by the Investigator Using a 4-Point Scale

  Day 29

Study Arms (4)

AGN-190168 Formulation 1

EXPERIMENTAL

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

Drug: AGN-190168 Formulation 1

AGN-190168 Formulation 2

EXPERIMENTAL

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

Drug: AGN-190168 Formulation 2

TAZORAC® Gel 0.1%

ACTIVE COMPARATOR

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.

Drug: tazarotene gel 0.1%

TAZORAC® Cream 0.1%

ACTIVE COMPARATOR

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.

Drug: tazarotene cream 0.1%

Interventions

AGN-190168 Formulation 1 DRUG

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

AGN-190168 Formulation 1

AGN-190168 Formulation 2 DRUG

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

AGN-190168 Formulation 2

tazarotene gel 0.1% DRUG

Tazarotene gel 0.1% applied topically to the face, neck, upper chest, upper back, and shoulders once daily for 29 days.

Also known as: TAZORAC® Gel 0.1%

TAZORAC® Gel 0.1%

tazarotene cream 0.1% DRUG

Tazarotene cream 0.1% cream applied topically to the face, neck, upper chest, upper back, and shoulders once daily for 29 days.

Also known as: TAZORAC® Cream 0.1%

TAZORAC® Cream 0.1%

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Allergan: lead

Study Sites (1)

Unknown Facility

College Station, Texas, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Study Officials

• Medical Director

  Allergan

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2014
• First Posted: August 15, 2014
• Study Start: August 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: April 30, 2015

Record last verified: 2015-04

Locations

US (1)