Last updated: 11/07/2018 07:53:54

A Study to Evaluate the Bioavailability of Tazarotene Foam, 0.1%, and Tazorac Gel, 0.1%, in Subjects with Acne Vulgaris

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GSK study ID
114565
See study documents
Clinicaltrials.gov ID
NCT01019603
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A Single-Center, Randomized, Open-Label Study to Evaluate the Bioavailability of Tazarotene Foam, 0.1%, and Tazorac Gel, 0.1%, in Subjects with Acne Vulgaris
Trial description: The purpose of this study is to assess systemic exposure of a new foam formulation of tazarotene, 0.1% compared with Tazorac Gel, 0.1%. The study design and dosing regimen are based on previous clinical studies with Tazorac Gel and Tazorac Cream.
Primary purpose:
Basic Science
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Plasma concentrations of tazarotenic acid in subjects with acne vulgaris

Timeframe: Days 1, 8, 12, 15, 18, 20, 22 (pre-dose and 3, 4.5, 6, 7.5, 9, 12, 16, 20, 24, 38, 48, 62, and 72 hr post-dose

Secondary outcomes:
Not applicable
Interventions:
  • Drug: Tazarotene
  • Drug: Tazaroc Gel
    • Enrollment:
    30
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Michael Jarratt, Cary P Werner, & Alessandra B Alio Saenz. Relative bioavailability of tazarotenic acid when administered as tazarotene foam or tazarotene gel in subjects with moderate-to-severe acne vulgaris . Clinical Drug Investigation . 2013;33(4):283-289.
    Medical condition
    Acne Vulgaris
    Product
    tazarotene
    Collaborators
    GSK
    Study date(s)
    October 2009 to December 2009
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    12+ years
    Accepts healthy volunteers
    No
    • Male or female 12 years of age or older who is in good general health.
    • Have an Investigator’s Static Global Assessment (ISGA) score of 3 or greater at baseline. The area considered for the ISGA must be confined to the face.
    • Female who is pregnant, trying to become pregnant, or breast feeding.
    • History of known or suspected intolerance to any of the ingredients of the study products.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Male or female 12 years of age or older who is in good general health.
    • Have an Investigator’s Static Global Assessment (ISGA) score of 3 or greater at baseline. The area considered for the ISGA must be confined to the face.
    • Regular menstrual cycle prior to study entry (as reported by the subject) for females of childbearing potential.

      • Negative urine pregnancy test for females of childbearing potential.

      • Sexually active females of childbearing potential participating in the study must agree to use a medically acceptable method of contraception while receiving protocol-assigned product. A woman of childbearing potential is defined as one who is biologically capable of becoming pregnant; including perimenopausal women who are less than 2 years from their last menses. Women who are not currently sexually active must agree to use medically accepted methods of contraception should they become sexually active while participating in the study. Male subjects and/or their partners must use a medically acceptable form of contraception.
    • Nonsmoker or smoker with at least 30 days abstinence from smoking or using nicotine-containing products prior to study entry and willing not to smoke or to use nicotine-containing products throughout the study.
    • Ability and willingness to follow all study procedures, attend all scheduled visits, and successfully complete the study.
    • Capable of understanding and willing to provide signed and dated written voluntary informed consent before any protocol specific procedures are performed
    Exclusion criteria:
    • Female who is pregnant, trying to become pregnant, or breast feeding.
    • History of known or suspected intolerance to any of the ingredients of the study products.
    • Use of topical antibiotics or topical corticosteroids for acne treatment within the past 2 weeks.
    • Use of systemic corticosteroids within the past 4 weeks.
    • Use of systemic retinoids (eg, isotretinoin) within the past 6 months.
    • Concurrent use of medications known to be photosensitizers because of the possibility of augmented photosensitivity.
    • Use of topical anti-acne medications (eg, benzoyl peroxide, retinoids) within the past 2 weeks.
    • Concomitant use of of facial products such as: abradants, facials, peels containing glycolic or other acids .
    • Facial procedure (eg, chemical or laser peel or microdermabrasion) performed by an esthetician, beautician, physician, nurse, or other practitioner within the past 2 weeks.
    • History or evidence of skin conditions other than acne (eg, eczema) that would interfere with the subject’s participation in the study.
    • Consumption of alcohol within 24 hours prior to study product application on days 8, 12, 15, 18, 20, and 22 and within 72 hours post application on day 22.
    • Consumption of xanthine-containing beverages or products (eg, caffeinated coffee, tea, over-the counter medication for cold symptoms) within 24 hours prior to study product application on days 8, 12, 15, 18, 20, and 22 and within 72 hours post-application on day 22.
    • Anticipated need to engage in activities or exercise that would cause profuse sweating during the study.
    • Anticipated need for surgery or hospitalization during the study.
    • Require or desire excessive or prolonged exposure to ultraviolet light (eg, sunlight or tanning beds) during the study.
    • Concurrent involvement in another investigational study or participation within 30 days prior to the start of this study.
    • Any other condition that, in the judgment of the investigator, would put the subject at unacceptable risk for participation in the study.
    • Currently lives in the same household as currently enrolled subjects; is an employee of Stiefel, an investigator, or a contract research organization involved in the study; or is an immediate family member (eg, partner, offspring, parents) of an employee involved in the study.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    DermResearch, Inc.
    Austin, TX, United States, 78759
    Status
    Study Complete
    Contact us

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2009-20-12

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

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    Additional information
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