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
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
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
Observational study model:
Not applicable
Primary completion date:
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.
- 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
Negative urine pregnancy test for females of childbearing potential.
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)
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
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.
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