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

NCT01017146 | Completed Phase 3 Results

• 1 other identifier: 114575
• Study Type: interventional
• Target: 744
• Locations: 2 countries
• Sites: 22

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.

Conditions

Acne Vulgaris

Keywords

Ance

Outcome Measures

Primary Outcomes (3)

• Absolute Change in Lesion Counts (LCs) From Baseline to Week 12

  LC: count of all inflammatory lesions (ILs, i.e., papules, pustules, and nodules) and non-inflammatory lesions (NILs, i.e., open and closed comedones) at Baseline and at Week 12. Total lesions (TLs) were calculated as the sum of ILs and NILs. LC was confined to the face (including forehead, nose, checks, and chin). Change from Baseline at Week 12 was calculated as the value at Week 12 minus the value at Baseline.

  Baseline (Week 0/Day 1) and Week 12

• Number of Participants With a Minimum 2-grade (G) Improvement in the Investigator Static Global Assessment (ISGA) Score From Baseline at Week 12

  Investigators evaluated the acne severity (S) of the participants' face using the ISGA scale, ranging from 0 to 5: 0=clear skin with no ILs or NILs; 1=almost clear: rare NIL with no more than rare papules; 2=mild S: \>G 1, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions \[NLs\]); 3=moderate S: \>G 2, up to many NILs and may have some ILs, but no more than one small NL; 4=severe: greater than G 3, up to many NILs and ILs, but no more than a few NLs; 5=very severe: many NILs and ILs and more than a few NLs, may have cystic lesions.

  Baseline (Week 0/Day 1) and Week 12

• Number of Participants With an ISGA Score of 0 or 1 at Week 12

  Investigators evaluated the acne severity (S) of the participants' face using the ISGA scale, ranging from 0 to 5: 0=clear skin with no ILs or NILs; 1=almost clear: rare NIL with no more than rare papules; 2=mild S: \>G 1, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions \[NLs\]); 3=moderate S: \>G 2, up to many NILs and may have some ILs, but no more than one small NL; 4=severe: greater than G 3, up to many NILs and ILs, but no more than a few NLs; 5=very severe: many NILs and ILs and more than a few NLs, may have cystic lesions.

  Week 12

Secondary Outcomes (13)

• Percent Change in LC From Baseline at Weeks 2, 4, 8, and 12

  Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12

• Absolute Change From Baseline in LC at Weeks 2, 4, and 8

  Baseline (Week 0/Day 1); Weeks 2, 4, and 8

• Time to a 50 Percent Reduction in Total Lesion Counts (TLC)

  Baseline (Week 0/Day 1) to Week 12

• Number of Participants With a Minimum 2-grade Improvement in ISGA Score at Weeks 2, 4, and 8

  Baseline (Week 0/Day 1); Weeks 2, 4, and 8

• Number of Participants With an ISGA Score of 0 or 1 at Weeks 2, 4, and 8

  Weeks 2, 4, and 8

Study Arms (2)

1

EXPERIMENTAL

Tazarotene foam, 0.1%

Drug: Tazarotene foam

2

PLACEBO COMPARATOR

Vehicle Foam

Drug: Vehicle Foam

Interventions

Tazarotene foam DRUG

Tazarotene foam once a day application to the face

1

Vehicle Foam DRUG

Vehicle Foam once a day application to the face

2

Eligibility Criteria

• Age: 12 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (22)

Cherry Creek Research, Inc.

Denver, Colorado, 80209, United States

Location

Cosmetic Medicine & Treatment Research Insttitute, Inc.

Miami Beach, Florida, 33140, United States

Location

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, 46260, United States

Location

Minnesota Clinical Study Center

Fridley, Minnesota, 55432, United States

Location

Academic Dermatology Associates

Albuquerque, New Mexico, 87106, United States

Location

DermResearch Center of New York, Inc.

Stony Brook, New York, 11790, United States

Location

Dermatology Consulting Services

High Point, North Carolina, 27262, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

The Dermatology Research of Cincinnati

Cincinnati, Ohio, 45220, United States

Location

Group Health Associates

Cincinnatti, Ohio, 45220, United States

Location

Haber Dermatology & Cosmetic Surgery, Inc.

South Euclid, Ohio, 44118, United States

Location

Oregon Dermatology and Research Center

Portland, Oregon, 97210, United States

Location

Yardley Dermatology Associates

Yardley, Pennsylvania, 19067, United States

Location

The Skin Wellness Center, PC

Knoxville, Tennessee, 37922, United States

Location

Dermatology Research Associates, Inc.

Nashville, Tennessee, 37203, United States

Location

DermResearch, Inc.

Austin, Texas, 78759, United States

Location

J & S Studies, Inc.

College Station, Texas, 77845, United States

Location

Dermatology Treatment & Research Center

Dallas, Texas, 75230, United States

Location

Aurora Advanced Healthcare, Inc. Clinical Research Center

Milwaukee, Wisconsin, 53209, United States

Location

Ultranova Skincare

Barrie, Ontario, L4M 6L2, Canada

Location

Dermatrials Research

Hamilton, Ontario, L8N 1V6, Canada

Location

Nexus Clinical Research

St. John's, NL A1B 3E1, Canada

Location

Related Publications (1)

• 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.

  PMID: 23652892 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.

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2009
• First Posted: November 20, 2009
• Study Start: October 1, 2009
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: January 18, 2017
• Results First Posted: July 6, 2012

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will share

Locations

US (19); CA (3)