A Study to Evaluate the Safety and Efficacy of Tazarotene Foam, 0.1%, in Subjects With Common Facial Acne - W0260-301

Completed · Phase 3

Conditions studied: Acne Vulgaris

In brief

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

Key facts

Study ID

NCT01017146

Run by

Stiefel, a GSK Company

People needed

744

Starts

2009-10-01

Expected to finish

2010-11-01

Last updated by the study team

2017-01-18

Who can join

Age: 12 and older, up to 45. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• Between 25 and 50 facial inflammatory lesions and no more than 1 facial nodular lesion (<5mm), with NO cystic lesions.
• 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.

You may not qualify if…

• 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

Where it is running

• Cherry Creek Research, Inc. — Denver, Colorado, United States
• Cosmetic Medicine & Treatment Research Insttitute, Inc. — Miami Beach, Florida, United States
• Dawes Fretzin Clinical Research Group, LLC — Indianapolis, Indiana, United States
• Minnesota Clinical Study Center — Fridley, Minnesota, United States
• Academic Dermatology Associates — Albuquerque, New Mexico, United States
• DermResearch Center of New York, Inc. — Stony Brook, New York, United States
• Dermatology Consulting Services — High Point, North Carolina, United States
• Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States
• The Dermatology Research of Cincinnati — Cincinnati, Ohio, United States
• Group Health Associates — Cincinnatti, Ohio, United States
• Haber Dermatology & Cosmetic Surgery, Inc. — South Euclid, Ohio, United States
• Oregon Dermatology and Research Center — Portland, Oregon, United States
• Yardley Dermatology Associates — Yardley, Pennsylvania, United States
• The Skin Wellness Center, PC — Knoxville, Tennessee, United States
• Dermatology Research Associates, Inc. — Nashville, Tennessee, United States
• DermResearch, Inc. — Austin, Texas, United States
• J & S Studies, Inc. — College Station, Texas, United States
• Dermatology Treatment & Research Center — Dallas, Texas, United States
• Aurora Advanced Healthcare, Inc. Clinical Research Center — Milwaukee, Wisconsin, United States
• Ultranova Skincare — Barrie, Ontario, Canada
• Dermatrials Research — Hamilton, Ontario, Canada
• Nexus Clinical Research — St. John's, Canada

Full record on ClinicalTrials.gov

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