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

Completed · Phase 1

Conditions studied: Acne Vulgaris

In brief

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.

Key facts

Study ID

NCT01019603

Run by

Stiefel, a GSK Company

People needed

30

Starts

2009-10-12

Expected to finish

2009-12-20

Last updated by the study team

2017-06-23

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• DermResearch, Inc. — Austin, Texas, United States

Full record on ClinicalTrials.gov

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