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
1 other identifier
interventional
591
1 country
16
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2008
Shorter than P25 for phase_2
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
July 7, 2008
CompletedFirst Posted
Study publicly available on registry
July 11, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedResults Posted
Study results publicly available
March 6, 2017
CompletedMarch 6, 2017
January 1, 2017
9 months
July 7, 2008
November 12, 2016
January 13, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
Percent Change From Baseline to Week 12 in Each of 3 Lesion Counts (Total, Inflammatory, and Non-inflammatory)
Baseline and up to Week 12
Proportion of Participants With an ISGA Score of 0 or 1 at Week 12
Week 12
Study Arms (6)
1
EXPERIMENTALBenzoyl peroxide/clindamycin gel + tazarotene cream
2
ACTIVE COMPARATORBenzoyl peroxide/clindamycin gel + vehicle cream
3
ACTIVE COMPARATORBenzoyl peroxide gel + tazarotene cream
4
ACTIVE COMPARATORClindamycin gel + tazarotene cream
5
ACTIVE COMPARATORVehicle gel+ tazarotene cream
6
PLACEBO COMPARATORVehicle gel + vehicle cream
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Stiefel, a GSK Companylead
- GlaxoSmithKlinecollaborator
Study Sites (16)
Dermatology Research of Arkansas
Little Rock, Arkansas, 72205, United States
Center for Dermatology Cosmetic and Laser Surgery
Fremont, California, 94538, United States
Center for Dermatology and Laser Surgery
Sacramento, California, 95819, United States
Boulder Medical Center, P.C.
Boulder, Colorado, 80304, United States
Dermatology Associates Research
Coral Gables, Florida, 33134, United States
MedaPhase, Inc.
Newnan, Georgia, 30263, United States
Callender Center for Clinical Research
Mitchellville, Maryland, 20721, United States
Grekin Skin Institute
Warren, Michigan, 48088, United States
University of North Carolina Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Dermatology Consulting Services
High Point, North Carolina, 27262, United States
MS Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Rivergate Dermatology & Skin Care Center
Goodlettsville, Tennessee, 37072, United States
The Skin Wellness Center, PC
Knoxville, Tennessee, 37922, United States
Dermatology Treatment & Research Center
Dallas, Texas, 75230, United States
Suzanne Bruce and Associates, PA
Houston, Texas, 77056, United States
Dermatology Clinical Research Center of San Antonio
San Antonio, Texas, 78229, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- 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
July 7, 2008
First Posted
July 11, 2008
Study Start
June 1, 2008
Primary Completion
March 1, 2009
Study Completion
March 1, 2009
Last Updated
March 6, 2017
Results First Posted
March 6, 2017
Record last verified: 2017-01