Last updated: 07/17/2024 15:39:50
Safety and efficacy study of Clindamycin/benzoyl peroxide/tazarotene cream in subjects with acne
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Absolute change in lesion counts (total, inflammatory, and non-inflammatory) from Baseline to Week 12
Timeframe: 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
Timeframe: Baseline and up to Week 12
Secondary outcomes:
Percent change from Baseline to Week 12 in each of 3 lesion counts (total, inflammatory, and non-inflammatory)
Timeframe: Baseline and up to Week 12
Proportion of Participants with an ISGA score of 0 or 1 at Week 12
Timeframe: Week 12
Interventions:
Drug: Benzoyl peroxide gel
Drug: Clindamycin gel
Drug: Tazarotene cream
Drug: Vehicle gel
Drug: Vehicle cream
Enrollment:
591
Observational study model:
Not applicable
Primary completion date:
2009-02-03
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Acne Vulgaris
Product
benzoyl peroxide, benzoyl peroxide/clindamycin/tazarotene, clindamycin phosphate, tazarotene
Collaborators
GSK
Study date(s)
June 2008 to March 2009
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
12 - 45 years
Accepts healthy volunteers
No
- Inclusion Criteria: Subjects must be males or females 12 to 45 years of age.
- Subjects must have acne on their face.
- 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
Inclusion and exclusion 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.
Trial location(s)
Location
Dermatology Research of Arkansas
Little Rock, AR, United States, 72205
Status
Study Complete
Location
Dermatology Consulting Services
High Point, NC, United States, 27262
Status
Study Complete
Location
The Skin Wellness Center, PC
Knoxville, TN, United States, 37922
Status
Study Complete
Location
Center for Dermatology Cosmetic and Laser Surgery
Fremont, CA, United States, 94538
Status
Study Complete
Location
Callender Center for Clinical Research
Mitchellville, MD, United States, 20721
Status
Study Complete
Location
Dermatology Associates Research
Coral Gables, FL, United States, 33134
Status
Study Complete
Location
Dermatology Clinical Research Center of San Antonio
San Antonio, TX, United States, 78229
Status
Study Complete
Location
Center for Dermatology and Laser Surgery
Sacramento, CA, United States, 95819
Status
Study Complete
Location
Dermatology Treatment & Research Center
Dallas, TX, United States, 75230
Status
Study Complete
Location
Rivergate Dermatology & Skin Care Center
Goodlettsville, TN, United States, 37072
Status
Study Complete
Location
Suzanne Bruce and Associates, PA
Houston, TX, United States, 77056
Status
Study Complete
Location
University of North Carolina Chapel Hill
Chapel Hill, NC, United States, 27599
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2009-02-03
Actual study completion date
2009-02-03
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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