Safety and Efficacy Study of Clindamycin/Benzoyl Peroxide/Tazarotene Cream in Subjects With Acne

• ClinicalTrials.gov Identifier: NCT00713609
• Recruitment Status: Completed
• First Posted: July 11, 2008
• Results First Posted: March 6, 2017
• Last Update Posted: March 6, 2017
• Sponsor: Stiefel, a GSK Company
• Collaborator: GlaxoSmithKline
• Information provided by (Responsible Party): GlaxoSmithKline ( Stiefel, a GSK Company )

Study Description

Brief Summary:

Benzoyl peroxide, clindamycin and tazarotene are known to be effective treatment alternative for acne vulgaris. The purpose of this study is to assess the safety and efficacy of a combination product including these actives for the treatment of acne vulgaris.

You may be suitable to take part in this study because you have acne vulgaris on your face. Acne vulgaris usually affects the face, but it can also affect the skin on the chest, arms, legs, and back.

Condition or disease	Intervention/treatment	Phase
Acne Vulgaris	Drug: Benzoyl peroxide gel; Drug: Clindamycin gel; Drug: Tazarotene cream; Drug: Vehicle gel; Drug: Vehicle cream	Phase 2

Detailed Description:

The study subjects must have acne vulgaris and will apply study drug to their face for 12 weeks.

Study visits will occur at baseline (day 1) and at weeks 2, 4, 8, and 12. Subjects will be assessed at every visit to determine how the study drug is working. Safety will be assessed by evaluation of adverse events (AEs), vital signs, physical examinations, and withdrawals from the study.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 591 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Multi-center, Randomized, Double-blind, Vehicle-Controlled, Phase 2 Study of the Safety and Efficacy of Benzoyl Peroxide/Clindamycin Gel and Tazarotene Cream When Used in Combination in the Treatment of Acne Vulgaris
• Study Start Date: June 2008
• Actual Primary Completion Date: March 2009
• Actual Study Completion Date: March 2009

Arms and Interventions

Arm	Intervention/treatment
Experimental: 1; Benzoyl peroxide/clindamycin gel + tazarotene cream	Drug: Benzoyl peroxide gel; 5% benzoyl peroxide in a gel applied topically once a day; Drug: Clindamycin gel; 1% clindamycin phosphate applied topically once a day; Drug: Tazarotene cream; 0.1 % tazarotene in a cream applied topically once a day
Active Comparator: 2; Benzoyl peroxide/clindamycin gel + vehicle cream	Drug: Benzoyl peroxide gel; 5% benzoyl peroxide in a gel applied topically once a day; Drug: Clindamycin gel; 1% clindamycin phosphate applied topically once a day; Drug: Vehicle cream; Vehicle cream is an identical cream without the active ingredients
Active Comparator: 3; Benzoyl peroxide gel + tazarotene cream	Drug: Benzoyl peroxide gel; 5% benzoyl peroxide in a gel applied topically once a day; Drug: Tazarotene cream; 0.1 % tazarotene in a cream applied topically once a day
Active Comparator: 4; Clindamycin gel + tazarotene cream	Drug: Clindamycin gel; 1% clindamycin phosphate applied topically once a day; Drug: Tazarotene cream; 0.1 % tazarotene in a cream applied topically once a day
Active Comparator: 5; Vehicle gel+ tazarotene cream	Drug: Tazarotene cream; 0.1 % tazarotene in a cream applied topically once a day; Drug: Vehicle gel; Vehicle gel is an identical gel without the active ingredients
Placebo Comparator: 6; Vehicle gel + vehicle cream	Drug: Vehicle gel; Vehicle gel is an identical gel without the active ingredients; Drug: Vehicle cream; Vehicle cream is an identical cream without the active ingredients

Outcome Measures

Primary Outcome Measures :

1. Absolute Change in Lesion Counts (Total, Inflammatory, and Non-inflammatory) From Baseline to Week 12 [ Time Frame: Baseline and up to Week 12 ]
   The investigator or designee took count of inflammatory lesions (papules, pustules, nodules and cysts [only post-Baseline]) (ILC), noninflammatory lesions (open and closed comedones) (NILC) and total lesions (TLC) at Baseline, Weeks 2, 4, 8, and 12. Lesion counts were confined to the face. Each of 3 lesion counts (total, inflammatory and non-inflammatory) was analyzed using an analysis of covariance (ANCOVA) model with terms for treatment, center, Baseline value and treatment-by-center interaction. If the interaction was not significant at 0.1 level, this interaction was excluded in ANCOVA model. Day 1 (Visit 1) was defined as Baseline. Only participants available at specified timepoints were analyzed (represented by n=X in the category titles).
2. Proportion of Participants With a Minimum 2-grade Improvement in the Investigator's Static Global Assessment (ISGA) Score From Baseline to Week 12 [ Time Frame: Baseline and up to Week 12 ]
   An ISGA was obtained at Baseline and at Weeks 2, 4, 8, and 12. The scores range from 0-5 (0=clear skin with no inflammatory or non-inflammatory lesions; 5=very severe with many non-inflammatory and inflammatory lesions and more than a few nodular lesions (may have cystic lesions). The higher score indicates more severe. The area considered for the ISGA was confined to the face. When possible, the same efficacy assessor performed all ISGA assessments on the same participant at all visits. Day 1 (Visit 1) was defined as Baseline. Only participants available at specified time points were analyzed.

Secondary Outcome Measures :

1. Percent Change From Baseline to Week 12 in Each of 3 Lesion Counts (Total, Inflammatory, and Non-inflammatory) [ Time Frame: Baseline and up to Week 12 ]
   The investigator or designee took count of inflammatory lesions (papules, pustules, nodules and cysts) (ILC), noninflammatory lesions (open and closed comedones) (NILC) and total lesions (TLC) at Baseline, Weeks 2, 4, 8, and 12. Lesion counts were confined to the face. Each of 3 lesion counts (total, inflammatory and non-inflammatory) was analyzed using an analysis of covariance (ANCOVA) model with terms for treatment, center, Baseline value and treatment-by-center interaction. If the interaction was not significant at 0.1 level, this interaction was excluded in ANCOVA model. Day 1 (Visit 1) was defined as Baseline. Only participants available at specified timepoints were analyzed (represented by n=X in the category titles).
2. Proportion of Participants With an ISGA Score of 0 or 1 at Week 12 [ Time Frame: Week 12 ]
   An ISGA was obtained at Baseline and at Weeks 2, 4, 8, and 12. The scores range from 0-5 (0=clear skin with no inflammatory or non-inflammatory lesions; 5=very severe with many non-inflammatory and inflammatory lesions and more than a few nodular lesions (may have cystic lesions). The higher score indicates more severe. The area considered for the ISGA was confined to the face. When possible, the same efficacy assessor performed all ISGA assessments on the same participant at all visits. Day 1 (Visit 1) was defined as Baseline. Only participants available at specified time points were analyzed.

Eligibility Criteria

• Ages Eligible for Study: 12 Years to 45 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Inclusion Criteria: Subjects must be males or females 12 to 45 years of age.
• Subjects must have acne on their face.
• Female subjects of childbearing potential must have a negative pregnancy test. If sexually active, one medically acceptable forms of contraception must be practiced from baseline to the last study visit.
• Subjects must have the ability and willingness to follow all study procedures, attend all scheduled visits, and successfully complete the study.
• Subjects must be capable of understanding and willing to provide signed and dated written voluntary informed consent (and any local or national authorization requirements).
• Subjects must be able to complete the study and to comply with study instructions.

Exclusion Criteria:

• Subjects who are pregnant, trying to become pregnant, or breast-feeding.
• Subjects with conditions that may influence the safety and or efficacy assessments of the study including, but not limited to: regional enteritis or inflammatory bowel disease, lupus, dermatomyositis, rosacea, seborrheic dermatitis, beard folliculitis, or perioral dermatitis, subject who are immunocompromised or have had any major illness within 30 days before the screening examination
• History of known or suspected intolerance including any known hypersensitivity or previous allergic reaction to any of the ingredients of the study products
• Subjects who have used topical antibiotics or topical steroids on the face, facial procedures, or any investigational therapy within the past 4 weeks or systemic retinoids within the past 6 months.
• Subjects who have any other disease or condition, or are using any medication, that in the judgment of the investigator would put the subject at unacceptable risk for participation in the study.
• Other exclusion criteria may apply.

Contacts and Locations

Locations

United States, Arkansas

Dermatology Research of Arkansas

Little Rock, Arkansas, United States, 72205

United States, California

Center for Dermatology Cosmetic and Laser Surgery

Fremont, California, United States, 94538

Center for Dermatology and Laser Surgery

Sacramento, California, United States, 95819

United States, Colorado

Boulder Medical Center, P.C.

Boulder, Colorado, United States, 80304

United States, Florida

Dermatology Associates Research

Coral Gables, Florida, United States, 33134

United States, Georgia

MedaPhase, Inc.

Newnan, Georgia, United States, 30263

United States, Maryland

Callender Center for Clinical Research

Mitchellville, Maryland, United States, 20721

United States, Michigan

Grekin Skin Institute

Warren, Michigan, United States, 48088

United States, North Carolina

University of North Carolina Chapel Hill

Chapel Hill, North Carolina, United States, 27599

Dermatology Consulting Services

High Point, North Carolina, United States, 27262

United States, Pennsylvania

MS Hershey Medical Center

Hershey, Pennsylvania, United States, 17033

United States, Tennessee

Rivergate Dermatology & Skin Care Center

Goodlettsville, Tennessee, United States, 37072

The Skin Wellness Center, PC

Knoxville, Tennessee, United States, 37922

United States, Texas

Dermatology Treatment & Research Center

Dallas, Texas, United States, 75230

Suzanne Bruce and Associates, PA

Houston, Texas, United States, 77056

Dermatology Clinical Research Center of San Antonio

San Antonio, Texas, United States, 78229

Sponsors and Collaborators

Stiefel, a GSK Company

GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials; GlaxoSmithKline

More Information

• Responsible Party: Stiefel, a GSK Company
• ClinicalTrials.gov Identifier: NCT00713609 History of Changes
• Other Study ID Numbers: 114570
• First Posted: July 11, 2008
• Results First Posted: March 6, 2017
• Last Update Posted: March 6, 2017
• Last Verified: January 2017

Keywords provided by GlaxoSmithKline ( Stiefel, a GSK Company ):

Acne; Acne Vulgaris; Pimples

Additional relevant MeSH terms:

Tazarotene; Acne Vulgaris; Acneiform Eruptions; Skin Diseases; Sebaceous Gland Diseases; Nicotinic Acids; Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Benzoyl Peroxide; Anti-Bacterial Agents; Anti-Infective Agents; Protein Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Dermatologic Agents; Keratolytic Agents; Vitamin B Complex; Vitamins; Micronutrients; Nutrients; Growth Substances; Physiological Effects of Drugs