A Study to Evaluate the Safety and Efficacy of Tazarotene Foam, 0.1%, in Subjects With Common Facial Acne - W0260-301

NCT ID: NCT01017146

Last Updated: 2017-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 744 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2010-11-30

Brief Summary

The purpose of this study is to assess safety and efficacy of a new foam formulation of tazarotene in subjects with acne vulgaris.

Detailed Description

A multicenter, randomized, double-blind, vehicle-controlled, parallel-group study comparing tazarotene foam with vehicle foam in subjects with acne vulgaris. Approximately 742 subjects will be enrolled and randomized to 1 of the 2 study product groups in a 1:1 ratio (tazarotene foam: vehicle foam). Subjects will apply tazarotene foam or vehicle foam to the entire face once daily for 12 weeks; study visits will occur at baseline (week 0/day 1) and at weeks 2, 4, 8, and 12.

Conditions

Acne Vulgaris

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

Tazarotene foam, 0.1%

Group Type: EXPERIMENTAL

Tazarotene foam

Intervention Type: DRUG

Tazarotene foam once a day application to the face

2

Vehicle Foam

Group Type: PLACEBO_COMPARATOR

Vehicle Foam

Intervention Type: DRUG

Vehicle Foam once a day application to the face

Interventions

Tazarotene foam

Tazarotene foam once a day application to the face

Intervention Type: DRUG

Vehicle Foam

Vehicle Foam once a day application to the face

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male or female age 12 through 45 years, inclusive, who is in good general health.
• An ISGA score of 3 or greater at baseline.
• Lesion counts meeting both of the following criteria:

1. Between 25 and 50 facial inflammatory lesions and no more than 1 facial nodular lesion (<5mm), with NO cystic lesions.

2. Between 30 and 125 facial noninflammatory lesions, excluding nasal lesions.

• Regular menstrual cycle prior to study entry 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 method 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.

• Capable of understanding and willing to provide signed and dated written voluntary informed consent before any protocol specific procedures are performed.
• Ability and willingness to follow all study procedures, attend all scheduled visits, and successfully complete the study.

Exclusion Criteria

• Female who is pregnant, trying to become pregnant, or breast feeding.
• Use of topical antibiotics on the face within the past 2 weeks.
• Use of systemic antibiotics for acne treatment within the past 4 weeks.
• Concurrent use of medications known to be photosensitizers (eg, thiazides, tetracyclines) because of the possibility of augmented photosensitivity.
• Use of topical corticosteroids on the face within the past 2 weeks or systemic corticosteroids within the past 4 weeks.
• Use of systemic retinoids (eg, isotretinoin) within the past 6 months.
• Treatment with estrogens, androgens, or anti-androgenic agents for 12 weeks or less immediately prior to study enrollment. Subjects that have been treated with these medications for more than 12 consecutive weeks prior to study enrollment are allowed to enroll as long as they do not expect to change the dose or drug, or to discontinue use during the study and it has not been indicated for the treatment of acne vulgaris.
• Use of topical anti-acne medications (eg, benzoyl peroxide, retinoids, or salicylates) within the past 2 weeks.
• Concomitant use of facial products such as: abradants, facials, peels containing glycolic or other acids, masks, washes or soaps.
• Concomitant use of medications that are reported to exacerbate acne (eg, mega-doses of certain vitamins, haloperidol, and immunosuppressants such as cyclosporine) as these may impact efficacy assessments. Multivitamins, iron supplements, and folate are acceptable.
• Facial procedure (eg, blue light, chemical or laser peel, or microdermabrasion) within the past 4 weeks.
• Require or desire excessive or prolonged exposure to ultraviolet light during the study.
• Known hypersensitivity or previous allergic reaction to any of the active components of the study product.
• A significant medical history of or currently immunocompromised.
• Use of any investigational product within the past 4 weeks or currently participating in another clinical study.
• Any other condition which, in the judgment of the investigator, would put the subject at unacceptable risk for participation in the study.
• Any major illness within 30 days before study enrollment.
• Currently lives in the same household as currently enrolled subjects; is an employee of Stiefel, an investigator, or a CRO involved in the study; or is an immediate family member (eg, partner, offspring, parents) of an employee involved in the study

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: collaborator

Stiefel, a GSK Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

Cherry Creek Research, Inc.

Denver, Colorado, United States

Cosmetic Medicine & Treatment Research Insttitute, Inc.

Miami Beach, Florida, United States

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, United States

Minnesota Clinical Study Center

Fridley, Minnesota, United States

Academic Dermatology Associates

Albuquerque, New Mexico, United States

DermResearch Center of New York, Inc.

Stony Brook, New York, United States

Dermatology Consulting Services

High Point, North Carolina, United States

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

The Dermatology Research of Cincinnati

Cincinnati, Ohio, United States

Group Health Associates

Cincinnatti, Ohio, United States

Haber Dermatology & Cosmetic Surgery, Inc.

South Euclid, Ohio, United States

Oregon Dermatology and Research Center

Portland, Oregon, United States

Yardley Dermatology Associates

Yardley, Pennsylvania, United States

The Skin Wellness Center, PC

Knoxville, Tennessee, United States

Dermatology Research Associates, Inc.

Nashville, Tennessee, United States

DermResearch, Inc.

Austin, Texas, United States

J & S Studies, Inc.

College Station, Texas, United States

Dermatology Treatment & Research Center

Dallas, Texas, United States

Aurora Advanced Healthcare, Inc. Clinical Research Center

Milwaukee, Wisconsin, United States

Ultranova Skincare

Barrie, Ontario, Canada

Dermatrials Research

Hamilton, Ontario, Canada

Nexus Clinical Research

St. John's, , Canada

Countries

United States; Canada

References

Feldman SR, Werner CP, Alio Saenz AB. The efficacy and tolerability of tazarotene foam, 0.1%, in the treatment of acne vulgaris in 2 multicenter, randomized, vehicle-controlled, double-blind studies. J Drugs Dermatol. 2013 Apr;12(4):438-46.

Reference Type: BACKGROUND

PMID: 23652892 (View on PubMed)

Study Documents

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

114575

Identifier Type: -

Identifier Source: org_study_id