Last updated: 11/03/2018 17:02:53
A clinical study to evaluate the tolerability of a topical antibiotic and retinoid used in a combined regimen with a BPO Wash
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A Phase 3B, Multicenter, Assessor-Blinded Study of the Tolerability of Clindamycin 1%-Tretinoin 0.025% Gel used in Conjunction with Benzoyl Peroxide 4% Wash in Subjects with Mild to Moderate Facial Acne Vulgaris
Trial description: The purpose of this study is to evaluate the tolerability of a combined regimen of a topical antibiotic and retinoid and a benzoyl peroxide wash.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Local tolerability - Skin Dryness
Timeframe: Screening/baseline
Local tolerability - Skin Dryness
Timeframe: Week 1
Local tolerability - Skin Dryness
Timeframe: Week 2
Local tolerability - Skin Dryness
Timeframe: Week 4
Local Tolerability - Skin scaling
Timeframe: Screening/baseline
Local Tolerability - Skin scaling
Timeframe: Week 1
Local Tolerability - Skin scaling
Timeframe: Week 2
Local Tolerability - Skin scaling
Timeframe: Week 4
Local tolerability - Erythema (redness)
Timeframe: Screening/baseline
Local tolerability - Erythema (redness)
Timeframe: Week 1
Local tolerability - Erythema (redness)
Timeframe: Week 2
Local tolerability - Erythema (redness)
Timeframe: Week 4
Secondary outcomes:
Subject Assessment of Burning/Stinging
Timeframe: Screening/baseline
Subject Assessment of Burning/Stinging
Timeframe: Week 1
Subject Assessment of Burning/Stinging
Timeframe: Week 2
Subject Assessment of Burning/Stinging
Timeframe: Week 4
Subject Assessment of Itching
Timeframe: Screening/Baseline
Subject Assessment of Itching
Timeframe: Week 1
Subject Assessment of Itching
Timeframe: Week 2
Subject Assessment of Itching
Timeframe: Week 4
Interventions:
Enrollment:
60
Primary completion date:
2009-05-06
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Draelos ZD, Potts A, Alió Saenz AB; W0265-306 Study Group.. Randomized tolerability analysis of clindamycin phosphate 1.2%-tretinoin 0.025% gel used with benzoyl peroxide wash 4% for acne vulgaris. Cutis. 2010 Dec;86(6):310-8.
Draelos ZD, Potts A, Alió Saenz AB, for the W0265-306 Study Group . Randomized Tolerability Analysis of Clindamycin Phosphate 1.2%–Tretinoin 0.025% Gel Used With Benzoyl Peroxide Wash 4% for Acne Vulgaris. [Cutis]. 2010;86:310-318.
Medical condition
Acne Vulgaris
Product
benzoyl peroxide, clindamycin phosphate, clindamycin phosphate/tretinoin, tretinoin
Collaborators
GlaxoSmithKline
Study date(s)
April 2009 to June 2009
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
12 - 45 years
Accepts healthy volunteers
No
- Subjects with mild to moderate facial acne vulgaris, with no history of known or suspected hypersensitivity or previous allergic reaction to any of the ingredients of the study products (eg, topical antibiotics, retinoids or benzoyl peroxide), capable of understanding and willing to provide signed and dated written voluntary informed consent and able to complete the study and to comply with study instructions.
- Female subjects of childbearing potential must have a negative urine pregnancy test result at baseline and practice a reliable method of contraception throughout the study.
- Use of topical antibiotics on the face within the past 2 weeks or use of systemic antibiotics within the past 4 weeks.
Inclusion and exclusion criteria
Inclusion criteria:
- Subjects with mild to moderate facial acne vulgaris, with no history of known or suspected hypersensitivity or previous allergic reaction to any of the ingredients of the study products (eg, topical antibiotics, retinoids or benzoyl peroxide), capable of understanding and willing to provide signed and dated written voluntary informed consent and able to complete the study and to comply with study instructions.
- Female subjects of childbearing potential must have a negative urine pregnancy test result at baseline and practice a reliable method of contraception throughout the study.
Exclusion criteria:
- Use of topical antibiotics on the face within the past 2 weeks or use of systemic antibiotics within the past 4 weeks.
Trial location(s)
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
Dermatology Associates Research
Coral Gables, FL, United States, 33134
Status
Study Complete
Study documents
Scientific result summary
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
Study complete
Actual primary completion date
2009-05-06
Actual study completion date
2009-05-06
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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