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

Primary Purpose

Acne Vulgaris

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
AGN-190168 Formulation 1
AGN-190168 Formulation 2
tazarotene gel 0.1%
tazarotene cream 0.1%
Sponsored by
Allergan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Acne Vulgaris

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Active Comparator

Arm Label

AGN-190168 Formulation 1

AGN-190168 Formulation 2

TAZORAC® Gel 0.1%

TAZORAC® Cream 0.1%

Arm Description

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

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

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 14, 2014
Last Updated
April 28, 2015
Sponsor
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT02218034
Brief Title
Safety, Tolerability and Pharmacokinetics of AGN-190168 in Subjects With Acne Vulgaris
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AGN-190168 Formulation 1
Arm Type
Experimental
Arm Description
AGN-190168 Formulation 1 applied topically to the face, neck, upper chest, upper back, and shoulders once daily for 29 days.
Arm Title
AGN-190168 Formulation 2
Arm Type
Experimental
Arm Description
AGN-190168 Formulation 2 applied topically to the face, neck, upper chest, upper back, and shoulders once daily for 29 days.
Arm Title
TAZORAC® Gel 0.1%
Arm Type
Active Comparator
Arm 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.
Arm Title
TAZORAC® Cream 0.1%
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
AGN-190168 Formulation 1
Intervention Description
AGN-190168 Formulation 1 applied topically to the face, neck, upper chest, upper back, and shoulders once daily for 29 days.
Intervention Type
Drug
Intervention Name(s)
AGN-190168 Formulation 2
Intervention Description
AGN-190168 Formulation 2 applied topically to the face, neck, upper chest, upper back, and shoulders once daily for 29 days.
Intervention Type
Drug
Intervention Name(s)
tazarotene gel 0.1%
Other Intervention Name(s)
TAZORAC® Gel 0.1%
Intervention Description
Tazarotene gel 0.1% applied topically to the face, neck, upper chest, upper back, and shoulders once daily for 29 days.
Intervention Type
Drug
Intervention Name(s)
tazarotene cream 0.1%
Other Intervention Name(s)
TAZORAC® Cream 0.1%
Intervention Description
Tazarotene cream 0.1% cream applied topically to the face, neck, upper chest, upper back, and shoulders once daily for 29 days.
Primary Outcome Measure Information:
Title
Maximum Plasma Level (Cmax) of AGN-190168
Time Frame
Day 29
Title
Maximum Plasma Level (Cmax) of AGN-190168 Metabolite
Time Frame
Day 29
Title
Local Dermal Tolerability as Assessed by the Subject Using a 4-Point Scale
Time Frame
Day 29
Title
Local Dermal Tolerability as Assessed by the Investigator Using a 4-Point Scale
Time Frame
Day 29

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
City
College Station
State/Province
Texas
Country
United States

12. IPD Sharing Statement

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

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