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A Study to Evaluate the Safety and Efficacy of Tazarotene Foam, 0.1%, in Subjects With Common Facial Acne
This study has been completed.

First Received on November 19, 2009.   Last Updated on November 10, 2011   History of Changes
Sponsor: Stiefel, a GSK Company
Collaborator: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01017120
  Purpose

The purpose of this study is to assess safety and efficacy of a new foam formulation of tazarotene in subjects with acne vulgaris.


Condition Intervention Phase
Acne Vulgaris
Drug: Tazarotene Foam
Drug: Vehicle Foam
Phase III

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Vehicle-Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of Tazarotene Foam, 0.1%, in Subjects With Acne Vulgaris

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Acne lesion counts and Investigator's Static Global Assessment (ISGA). [ Time Frame: Baseline, Weeks 2, 4, 8 and 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Local tolerability and adverse events [ Time Frame: Baseline, Weeks 2, 4, 8 and 12 ] [ Designated as safety issue: No ]

Enrollment: 742
Study Start Date: October 2009
Study Completion Date: December 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Tazarotene foam, 0.1%
Drug: Tazarotene Foam
Tazarotene foam once a day application to the face
Placebo Comparator: 2
Vehicle Foam
Drug: Vehicle Foam
Vehicle Foam once a day application to the face

Detailed Description:

A multicenter, randomized, double-blind, vehicle-controlled, parallel-group study comparing tazarotene foam with vehicle foam in subjects with acne vulgaris. Approximately 742 subjects will be enrolled and randomized to 1 of the 2 study product groups in a 1:1 ratio (tazarotene foam: vehicle foam). Subjects will apply tazarotene foam or vehicle foam to the entire face once daily for 12 weeks; study visits will occur at baseline (week 0/day 1) and at weeks 2, 4, 8, and 12.

  Eligibility

Ages Eligible for Study:   12 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female age 12 through 45 years, inclusive, who is in good general health.
  • An ISGA score of 3 or greater at baseline.
  • Lesion counts meeting both of the following criteria:

    1. Between 25 and 50 facial inflammatory lesions and no more than 1 facial nodular lesion (<5mm), with NO cystic lesions.
    2. Between 30 and 125 facial noninflammatory lesions, excluding nasal lesions. - Regular menstrual cycle prior to study entry 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 method 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.

  • Capable of understanding and willing to provide signed and dated written voluntary informed consent before any protocol specific procedures are performed.
  • Ability and willingness to follow all study procedures, attend all scheduled visits, and successfully complete the study.

Exclusion Criteria:

  • Female who is pregnant, trying to become pregnant, or breast feeding.
  • Use of topical antibiotics on the face within the past 2 weeks.
  • Use of systemic antibiotics for acne treatment within the past 4 weeks.
  • Concurrent use of medications known to be photosensitizers (eg, thiazides, tetracyclines) because of the possibility of augmented photosensitivity.
  • Use of topical corticosteroids on the face within the past 2 weeks or systemic corticosteroids within the past 4 weeks.
  • Use of systemic retinoids (eg, isotretinoin) within the past 6 months.
  • Treatment with estrogens, androgens, or anti-androgenic agents for 12 weeks or less immediately prior to study enrollment. Subjects that have been treated with these medications for more than 12 consecutive weeks prior to study enrollment are allowed to enroll as long as they do not expect to change the dose or drug, or to discontinue use during the study and it has not been indicated for the treatment of acne vulgaris.
  • Use of topical anti-acne medications (eg, benzoyl peroxide, retinoids, or salicylates) within the past 2 weeks.
  • Concomitant use of facial products such as: abradants, facials, peels containing glycolic or other acids, masks, washes or soaps.
  • Concomitant use of medications that are reported to exacerbate acne (eg, mega-doses of certain vitamins, haloperidol, and immunosuppressants such as cyclosporine) as these may impact efficacy assessments. Multivitamins, iron supplements, and folate are acceptable.
  • Facial procedure (eg, blue light, chemical or laser peel, or microdermabrasion) within the past 4 weeks.
  • Require or desire excessive or prolonged exposure to ultraviolet light during the study.
  • Known hypersensitivity or previous allergic reaction to any of the active components of the study product.
  • A significant medical history of or currently immunocompromised.
  • Use of any investigational product within the past 4 weeks or currently participating in another clinical study.
  • Any other condition which, in the judgment of the investigator, would put the subject at unacceptable risk for participation in the study.
  • Any major illness within 30 days before study enrollment.
  • Currently lives in the same household as currently enrolled subjects; is an employee of Stiefel, an investigator, or a CRO involved in the study; or is an immediate family member (eg, partner, offspring, parents) of an employee involved in the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01017120

Locations
United States, California
The Laser Institute for Dermatology
Santa Monica, California, United States, 90404
United States, Florida
FXM Research Corporation
Miami, Florida, United States, 33175
United States, Georgia
Atlanta Dermatology & Vein Research Center, PC
Alpharetta, Georgia, United States, 30022
Gwinnett Clinical Research Center, Inc.
Snellville, Georgia, United States, 30078
United States, Indiana
Hudson Dermatology
Evansville, Indiana, United States, 47714
United States, Kentucky
Dermatology Specialists
Louisville, Kentucky, United States, 40202
United States, Michigan
Henry Ford Medical Center
Detroit, Michigan, United States, 48202
Somerset Skin Centre
Troy, Michigan, United States, 48084
United States, Nebraska
Skin Specialists, P.C.
Omaha, Nebraska, United States, 68144
United States, New York
Dermatology Associates of Rochester, PC
Rochester, New York, United States, 14623
United States, Rhode Island
Clinical Partners, LLC
Johnston, Rhode Island, United States, 02919
United States, Texas
Suzanne Bruce and Associates, PA
Houston, Texas, United States, 77056
Progressive Clinical Research
San Antonio, Texas, United States, 78229
United States, Virginia
Virginia Clinical Research, Inc.
Norfolk, Virginia, United States, 23507
Canada, British Columbia
Guildford Dermatology Specialist
Surrey, British Columbia, Canada, V3R 6A7
Canada, Manitoba
Dermadvances Research
Winnipeg, Manitoba, Canada, R3C 1R4
Canada, Ontario
Lynderm Research, Inc.
Markham, Ontario, Canada, L3P 1A8
North Bay Dermatology Centre
North Bay, Ontario, Canada, P1B3Z7
Sponsors and Collaborators
Stiefel, a GSK Company
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT01017120     History of Changes
Other Study ID Numbers: 114576, W0260-302
Study First Received: November 19, 2009
Last Updated: November 10, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Acne

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases
Tazarotene
Keratolytic Agents
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012