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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02218034
Recruitment Status : Completed
First Posted : August 15, 2014
Last Update Posted : April 30, 2015
Sponsor:
Information provided by (Responsible Party):
Allergan

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

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: AGN-190168 Formulation 1 Drug: AGN-190168 Formulation 2 Drug: tazarotene gel 0.1% Drug: tazarotene cream 0.1% Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Basic Science
Study Start Date : August 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne
Drug Information available for: Tazarotene

Arms and Interventions
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Arm Intervention/treatment
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
AGN-190168 Formulation 1 applied topically to the face, neck, upper chest, upper back, and shoulders once daily for 29 days.
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
AGN-190168 Formulation 2 applied topically to the face, neck, upper chest, upper back, and shoulders once daily for 29 days.
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%
Tazarotene gel 0.1% applied topically to the face, neck, upper chest, upper back, and shoulders once daily for 29 days.
Other Name: TAZORAC® 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%
Tazarotene cream 0.1% cream applied topically to the face, neck, upper chest, upper back, and shoulders once daily for 29 days.
Other Name: TAZORAC® Cream 0.1%


Outcome Measures
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Primary Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02218034


Locations
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United States, Texas
College Station, Texas, United States
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Medical Director Allergan
More Information
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT02218034    
Other Study ID Numbers: 190168-069
First Posted: August 15, 2014    Key Record Dates
Last Update Posted: April 30, 2015
Last Verified: April 2015
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Nicotinic Acids
Tazarotene
 Dermatologic Agents
Keratolytic Agents
Vitamin B Complex
Vitamins
Micronutrients
Physiological Effects of Drugs