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

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01019603
First received: November 19, 2009
Last updated: February 23, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention Phase
Acne Vulgaris
Drug: Tazarotene
Drug: Tazaroc Gel
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: October 2009
Study Completion Date: January 2010
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Tazarotene foam 0.1%
Drug: Tazarotene
Topical Tazarotene foam applied daily for 22 days.
Other Name: Tazorac
Active Comparator: 2
Tazaroc Gel 0.1%
Drug: Tazaroc Gel
Topical tazarotene gel applied daily for 22 days.
Other Name: Tazorac

Detailed Description:

A single-center, randomized, open-label, phase 1, comparative bioavailability study in subjects with moderate to severe acne vulgaris. Approximately 30 subjects will be enrolled and randomized to 1 of the 2 study product groups in a 1:1 ratio (tazarotene foam: Tazorac Gel). Study product will be applied once daily for 22 days to the face, upper chest, upper back, and shoulders. Following the baseline visit, subjects will return to the study center daily for study product application. Blood samples to determine plasma concentrations of tazarotenic acid will be collected before study product application on days 1, 8, 12, 15, 18, 20, and 22, and collected at multiple time points over a 72 hour period on days 22 through 25.

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01019603

Locations
United States, Texas
DermResearch, Inc.
Austin, Texas, United States, 78759
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: NCT01019603     History of Changes
Other Study ID Numbers: 114565, W0260-105
Study First Received: November 19, 2009
Last Updated: February 23, 2012
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
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Keratolytic Agents

ClinicalTrials.gov processed this record on September 16, 2014