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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

Tracking Information
First Submitted Date  ICMJE August 14, 2014
First Posted Date  ICMJE August 15, 2014
Last Update Posted Date April 30, 2015
Study Start Date  ICMJE August 2014
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 14, 2014)
  • Maximum Plasma Level (Cmax) of AGN-190168 [ Time Frame: Day 29 ]
  • Maximum Plasma Level (Cmax) of AGN-190168 Metabolite [ Time Frame: Day 29 ]
  • Local Dermal Tolerability as Assessed by the Subject Using a 4-Point Scale [ Time Frame: Day 29 ]
  • Local Dermal Tolerability as Assessed by the Investigator Using a 4-Point Scale [ Time Frame: Day 29 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety, Tolerability and Pharmacokinetics of AGN-190168 in Subjects With Acne Vulgaris
Official Title  ICMJE Not Provided
Brief Summary This is a safety, tolerability and pharmacokinetics study of AGN-190168 in subjects with acne vulgaris.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Acne Vulgaris
Intervention  ICMJE
  • 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.
  • 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.
  • 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%
  • 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%
Study Arms  ICMJE
  • 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.
    Intervention: 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.
    Intervention: 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.
    Intervention: 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.
    Intervention: Drug: tazarotene cream 0.1%
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 25, 2015)
78
Original Estimated Enrollment  ICMJE
 (submitted: August 14, 2014)
72
Actual Study Completion Date  ICMJE March 2015
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02218034
Other Study ID Numbers  ICMJE 190168-069
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Allergan
Study Sponsor  ICMJE Allergan
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Allergan
PRS Account Allergan
Verification Date April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP