Last updated: 11/07/2018 07:51:46
A study to evaluate tolerability of two topical drug products in the treatment of facial acne
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A single-blind, randomized, comparative split-face study evaluating the tolerability of clindamycin and benzoyl peroxide gel to benzoyl peroxide/adapalene gel in the treatment of acne vulgaris.
Trial description: Multi-center, single-blind, randomized, comparative, split-face study. The duration of the study is 8 weeks. Commencing at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide gel and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Skin Dryness Score
Timeframe: Week 1, Week 2
Skin Peeling Score
Timeframe: Week 1, Week 2
Irritant/Allergic Contact Dermatitis Score
Timeframe: Week 1, Week 2
Erythema (Redness) Score
Timeframe: Week 1, Week 2
Secondary outcomes:
Erythema (Redness) Score
Timeframe: Week 5, Week 8
Skin Dryness Score
Timeframe: Week 5, Week 8
Skin Peeling Score
Timeframe: Week 5, Week 8
Irritant/Allergic Contact Dermatitis Score
Timeframe: Week 5, Week 8
Investigator Static Global Assessment Score
Timeframe: Week 5, Week 8
Inflammatory Acne Lesion Counts
Timeframe: Week 5, Week 8
Non-Inflammatory Acne Lesion Counts
Timeframe: Week 5, Week 8
Total Acne Lesion Counts
Timeframe: Week 5, Week 8
Skindex-29 Quality of Life Questionnaire - Symptomatic Domain
Timeframe: Baseline, and Week 8
Skindex-29 Quality of Life Questionnaire - Emotional Domain
Timeframe: Baseline, and Week 8
Skindex-29 Quality of Life Questionnaire - Functional Domain
Timeframe: Baseline, and Week 8
Skindex-29 Quality of Life Questionnaire - Global Score
Timeframe: Baseline, and Week 8
Product Acceptability and Preference Questionnaire - Severity of Redness
Timeframe: Week 1, Week 2
Product Acceptability and Preference Questionnaire - Severity of Redness
Timeframe: Week 8
Product Acceptability and Preference Questionnaire - Severity of Dryness
Timeframe: Week 1, Week 2
Product Acceptability and Preference Questionnaire - Severity of Dryness
Timeframe: Week 8
Product Acceptability and Preference Questionnaire - Severity of Burning
Timeframe: Week 1, Week 2
Product Acceptability and Preference Questionnaire - Severity of Burning
Timeframe: Week 8
Product Acceptability and Preference Questionnaire - Severity of Itching
Timeframe: Week 1, Week 2
Product Acceptability and Preference Questionnaire - Severity of Itching
Timeframe: Week 8
Product Acceptability and Preference Questionnaire - Severity of Scaling
Timeframe: Week 1, Week 2
Product Acceptability and Preference Questionnaire - Severity of Scaling
Timeframe: Week 8
Product Acceptability and Preference Questionnaire - Ease of Application of Product
Timeframe: Week 1, Week 2
Product Acceptability and Preference Questionnaire - Ease of Application of Product
Timeframe: Week 8
Product Acceptability and Preference Questionnaire - Comfort of Skin
Timeframe: Week 1, Week 2
Product Acceptability and Preference Questionnaire - Comfort of Skin
Timeframe: Week 8
Product Acceptability and Preference Questionnaire - Which Study Product is Subject More Satisfied with?
Timeframe: Week 1, Week 2
Product Acceptability and Preference Questionnaire - Comparison of Study Products to Products Used in the Past
Timeframe: Week 8
Product Acceptability and Preference Questionnaire - Decrease of Acne Breakouts by Study Products
Timeframe: Week 1, Week 2
Product Acceptability and Preference Questionnaire - Decrease of Acne Breakouts by Study Products
Timeframe: Week 8
Product Acceptability and Preference Questionnaire - Compliance
Timeframe: Week 1, Week 2
Product Acceptability and Preference Questionnaire - Compliance
Timeframe: Week 8
Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin
Timeframe: Week 1, Week 2
Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin
Timeframe: Week 8
Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment
Timeframe: Week 1, Week 2
Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment
Timeframe: Week 8
Product Acceptability and Preference Questionnaire - Ease of Use with Make-Up
Timeframe: Week 1, Week 2
Product Acceptability and Preference Questionnaire - Ease of Use with Make-Up
Timeframe: Week 8
Product Acceptability and Preference Questionnaire - Overall Satisfaction of Study Product
Timeframe: Week 1, Week 2
Product Acceptability and Preference Questionnaire - Overall Satisfaction of Study Product
Timeframe: Week 8
Interventions:
Enrollment:
28
Primary completion date:
2009-19-11
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Gonzalez P, Vila R, Cirigliano M. The tolerability profile of clindamycin 1%/benzoyl peroxide 5% gel vs. adapalene 0.1%/benzoyl peroxide 2.5% gel for facial acne: results of a randomized, single-blind, split-face study. [JCD]. 2012;11:251-260.
Medical condition
Acne Vulgaris
Product
benzoyl peroxide, benzoyl peroxide/clindamycin phosphate, clindamycin phosphate
Collaborators
GSK
Study date(s)
July 2009 to November 2009
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Male or female subjects at least 18 years of age, in good general health with documented diagnosis of facial acne vulgaris.
- Sexually active females of childbearing potential participating in the study must agree to use a medically acceptable method of contraception while receiving protocol-assigned product.
- Female subjects who are pregnant, trying to become pregnant or breastfeeding.
- Subjects who have any clinically relevant finding at their baseline physical examination or medical history such as severe systemic diseases, diseases of the facial skin, other than acne vulgaris.
Inclusion and exclusion criteria
Inclusion criteria:
- Male or female subjects at least 18 years of age, in good general health with documented diagnosis of facial acne vulgaris.
- Sexually active females of childbearing potential participating in the study must agree to use a medically acceptable method of contraception while receiving protocol-assigned product.
- Subjects willing to follow therapeutic instructions including avoidance of any other topical facial or systemic acne therapy during the conduct of the study.
- Capable of understanding and willing to provide signed and dated written voluntary informed consent before any protocol specific procedures are performed.
Exclusion criteria:
- Female subjects who are pregnant, trying to become pregnant or breastfeeding.
- Subjects who have any clinically relevant finding at their baseline physical examination or medical history such as severe systemic diseases, diseases of the facial skin, other than acne vulgaris.
- Facial hair that may obscure the accurate assessment of acne grade.
- History or presence of regional enteritis or inflammatory bowel disease (e.g., ulcerative colitis, pseudomembranous colitis, chronic diarrhea, or a history of antibiotic-associated colitis) or similar symptoms.
- Use of topical antibiotics on the face and systemic antibiotics within the past 2 and 4 weeks, respectively.
- Use of topical corticosteroids on the face or systemic corticosteroids within the past 4 weeks. Use of inhaled, intra-articular or intra-lesional (other than for facial acne lesions) steroids is acceptable.
- Use of systemic retinoids within the past 6 months.
- Concurrent use of drugs known to be photosensitizers (e.g., thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides) because of the possibility of increased phototoxicity.
- Concomitant use of neuromuscular blocking agents. Clindamycin has neuromuscular blocking activities, which may enhance the action of other neuromuscular blocking agents.
- Use of topical anti-acne medications within the past 2 weeks.
- Use of any investigational drugs or treatments during the study or within 4 weeks of the baseline visit.
Trial location(s)
Location
Aesthetics, Skin Care & Dermasurgery
Rockville, Maryland, United States, 20850
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
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
2009-19-11
Actual study completion date
2009-19-11
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
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