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

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

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.

Study Overview

• Status: Completed
• Conditions: Acne Vulgaris
• Intervention / Treatment: Drug: Benzoyl peroxide gel; Drug: Clindamycin gel; Drug: Tazarotene cream; Drug: Vehicle cream; Drug: Vehicle gel

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 Type: Interventional
• Enrollment (Actual): 591
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Dermatology Research of Arkansas
  • California
    • Fremont, California, United States, 94538
      • Center For Dermatology Cosmetic and Laser Surgery
    • Sacramento, California, United States, 95819
      • Center for Dermatology and Laser Surgery
  • Colorado
    • Boulder, Colorado, United States, 80304
      • Boulder Medical Center, P.C.
  • Florida
    • Coral Gables, Florida, United States, 33134
      • Dermatology Associates Research
  • Georgia
    • Newnan, Georgia, United States, 30263
      • MedaPhase, Inc.
  • Maryland
    • Mitchellville, Maryland, United States, 20721
      • Callender Center for Clinical Research
  • Michigan
    • Warren, Michigan, United States, 48088
      • Grekin Skin Institute
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina Chapel Hill
    • High Point, North Carolina, United States, 27262
      • Dermatology Consulting Services
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • MS Hershey Medical Center
  • Tennessee
    • Goodlettsville, Tennessee, United States, 37072
      • Rivergate Dermatology & Skin Care Center
    • Knoxville, Tennessee, United States, 37922
      • The Skin Wellness Center, PC
  • Texas
    • Dallas, Texas, United States, 75230
      • Dermatology Treatment & Research Center
    • Houston, Texas, United States, 77056
      • Suzanne Bruce and Associates, PA
    • San Antonio, Texas, United States, 78229
      • Dermatology Clinical Research Center of San Antonio

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

6

Arms and Interventions

Participant Group / 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 cream; Vehicle cream is an identical cream without the active ingredients; Drug: Vehicle gel; Vehicle gel is an identical gel without the active ingredients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absolute Change in Lesion Counts (Total, Inflammatory, and Non-inflammatory) From Baseline 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).	Baseline and up to Week 12
Proportion of Participants With a Minimum 2-grade Improvement in the Investigator's Static Global Assessment (ISGA) Score From Baseline 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.	Baseline and up to Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change From Baseline to Week 12 in Each of 3 Lesion Counts (Total, Inflammatory, and Non-inflammatory)	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).	Baseline and up to Week 12
Proportion of Participants With an ISGA Score of 0 or 1 at 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.	Week 12

Collaborators and Investigators

• Sponsor: Stiefel, a GSK Company
• Collaborators: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (Actual): March 1, 2009
• Study Completion (Actual): March 1, 2009

Study Registration Dates

• First Submitted: July 7, 2008
• First Submitted That Met QC Criteria: July 7, 2008
• First Posted (Estimate): July 11, 2008

Study Record Updates

• Last Update Posted (Actual): March 6, 2017
• Last Update Submitted That Met QC Criteria: January 13, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: Acne; Acne Vulgaris; Pimples
• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Dermatologic Agents; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Keratolytic Agents; Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Benzoyl Peroxide; Tazarotene
• Other Study ID Numbers: 114570