A Study to Evaluate the Bioavailability of Tazarotene Foam, 0.1%, and Tazorac Gel, 0.1%, in Subjects With Acne Vulgaris
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
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Texas
-
Austin, Texas, United States, 78759
- Dermresearch, Inc.
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
EXPERIMENTAL: 1
Tazarotene foam 0.1%
|
Topical Tazarotene foam applied daily for 22 days.
Other Names:
|
|
ACTIVE_COMPARATOR: 2
Tazaroc Gel 0.1%
|
Topical tazarotene gel applied daily for 22 days.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Plasma concentrations of tazarotenic acid in subjects with acne vulgaris
Time Frame: 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
|
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
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Study Start
Primary Completion (ACTUAL)
Primary Completion
Study Completion (ACTUAL)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
First Posted
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 114565
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Study Data/Documents
-
Statistical Analysis Plan
Information identifier: 114565Information comments: For additional information about this study please refer to the GSK Clinical Study Register
-
Informed Consent Form
Information identifier: 114565Information comments: For additional information about this study please refer to the GSK Clinical Study Register
-
Study Protocol
Information identifier: 114565Information comments: For additional information about this study please refer to the GSK Clinical Study Register
-
Clinical Study Report
Information identifier: 114565Information comments: For additional information about this study please refer to the GSK Clinical Study Register
-
Dataset Specification
Information identifier: 114565Information comments: For additional information about this study please refer to the GSK Clinical Study Register
-
Individual Participant Data Set
Information identifier: 114565Information comments: For additional information about this study please refer to the GSK Clinical Study Register
-
Annotated Case Report Form
Information identifier: 114565Information comments: For additional information about this study please refer to the GSK Clinical Study Register
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.