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CompletedNCT02218034Updated Apr 30, 2015

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

A Phase 1 interventional study of AGN-190168 Formulation 1 and AGN-190168 Formulation 2 in Acne Vulgaris, sponsored by Allergan. Completed at 1 site in United States. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2015-04-30.

Sponsored by Allergan · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
78
Allocation
Randomized
Ages
12 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Acne Vulgaris

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03

In context

Acne Vulgaris

730 studies on the registry are indexed under Acne Vulgaris; 86 are open to participants now.

This study's enrollment of 78 is above the median of 69 across 628 interventional studies indexed under Acne Vulgaris.

Browse Acne Vulgaris studies →

Lead sponsor

Allergan is the lead sponsor of 499 studies on the registry; none are open to participants now.

Of its 91 completed or terminated interventional studies of FDA-regulated products, 89 (98%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
78 participants (actual)

Study arms

  • Experimental
    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.

    Drug: AGN-190168 Formulation 1

  • Experimental
    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.

    Drug: AGN-190168 Formulation 2

  • Active comparator
    TAZORAC® 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.

    Drug: tazarotene gel 0.1%

  • Active comparator
    TAZORAC® 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.

    Drug: tazarotene cream 0.1%

Interventions

  • DrugAGN-190168 Formulation 1

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

  • DrugAGN-190168 Formulation 2

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

  • Drugtazarotene gel 0.1%

    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%

  • Drugtazarotene cream 0.1%

    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%

06

What researchers measure

Primary outcomes

  1. Maximum Plasma Level (Cmax) of AGN-190168

    Time frame: Day 29

  2. Maximum Plasma Level (Cmax) of AGN-190168 Metabolite

    Time frame: Day 29

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

    Time frame: Day 29

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

    Time frame: Day 29

07

Study locations

1 site
  • College Station, Texas, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 30, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02218034
Lead sponsor
Allergan
Responsible party
Sponsor
First posted
Aug 15, 2014
Start date
Aug 2014
Primary completion
Mar 2015
Completion
Mar 2015
Last update
Apr 30, 2015

Study contacts

Medical Director
study director · Allergan

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.

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