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

NCT01019603 | Completed Phase 1

• 1 other identifier: 114565
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acne Vulgaris

Keywords

Acne

Outcome Measures

Primary Outcomes (1)

• Plasma concentrations of tazarotenic acid in subjects with acne vulgaris

  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

Study Arms (2)

1

EXPERIMENTAL

Tazarotene foam 0.1%

Drug: Tazarotene

2

ACTIVE COMPARATOR

Tazaroc Gel 0.1%

Drug: Tazaroc Gel

Interventions

Tazarotene DRUG

Topical Tazarotene foam applied daily for 22 days.

Also known as: Tazorac

1

Tazaroc Gel DRUG

Topical tazarotene gel applied daily for 22 days.

Also known as: Tazorac

2

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Stiefel, a GSK Company: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

DermResearch, Inc.

Austin, Texas, 78759, United States

Location

Related Publications (1)

• Jarratt M, Werner CP, Alio Saenz AB. Tazarotene foam versus tazarotene gel: a randomized relative bioavailability study in acne vulgaris. Clin Drug Investig. 2013 Apr;33(4):283-9. doi: 10.1007/s40261-013-0065-1.

  PMID: 23456673 BACKGROUND

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
• Results for study 114565 can be found on the GSK Clinical Study Register.

MeSH Terms

Conditions

Acne Vulgaris

Interventions

tazarotene

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2009
• First Posted: November 25, 2009
• Study Start: October 12, 2009
• Primary Completion: December 20, 2009
• Study Completion: December 20, 2009
• Last Updated: June 23, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will share

Locations

US (1)