Clinical trial NCT00964223: A Study to Evaluate Tolerability of Two Topical Drug Products in the Treatment of Facial Acne
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acne Vulgaris
Keywords: Acne vulgaris
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
First posted: 2009-08-24
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Multi-center, single-blind, randomized, comparative, split-face study. The duration of the study is 8 weeks and consists of a baseline visit and visits at weeks 1, 2, 5 and 8. 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.

Blinding This is an investigator-blinded study; therefore, subjects and study-center staff will not be blinded to study treatment allocation (ie, left vs. right side application). During the first 2 weeks, the investigator will be unaware of which study product is being used on either side of the face. Subjects and study-center staff will be instructed not to reveal study treatment allocation to the investigator. Subjects will be instructed not to use study product in the presence of the investigator.

Eligibility 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.

Primary outcomes:
measure: Skin Dryness Score
timeFrame: Week 1, Week 2
measure: Skin Peeling Score
timeFrame: Week 1, Week 2
measure: Irritant/Allergic Contact Dermatitis Score
timeFrame: Week 1, Week 2
measure: Erythema (Redness) Score
timeFrame: Week 1, Week 2
Secondary outcomes:
measure: Erythema (Redness) Score
timeFrame: Week 5, Week 8
measure: Skin Dryness Score
timeFrame: Week 5, Week 8
measure: Skin Peeling Score
timeFrame: Week 5, Week 8
measure: Irritant/Allergic Contact Dermatitis Score
timeFrame: Week 5, Week 8
measure: Investigator Static Global Assessment Score
timeFrame: Week 5, Week 8
measure: Inflammatory Acne Lesion Counts
timeFrame: Week 5, Week 8
measure: Non-Inflammatory Acne Lesion Counts
timeFrame: Week 5, Week 8
measure: Total Acne Lesion Counts
timeFrame: Week 5, Week 8
measure: Skindex-29 Quality of Life Questionnaire - Symptomatic Domain
timeFrame: Baseline, and Week 8
measure: Skindex-29 Quality of Life Questionnaire - Emotional Domain
timeFrame: Baseline, and Week 8
measure: Skindex-29 Quality of Life Questionnaire - Functional Domain
timeFrame: Baseline, and Week 8
measure: Skindex-29 Quality of Life Questionnaire - Global Score
timeFrame: Baseline, and Week 8
measure: Product Acceptability and Preference Questionnaire - Severity of Redness
timeFrame: Week 1, Week 2
measure: Product Acceptability and Preference Questionnaire - Severity of Redness
timeFrame: Week 8
measure: Product Acceptability and Preference Questionnaire - Severity of Dryness
timeFrame: Week 1, Week 2
measure: Product Acceptability and Preference Questionnaire - Severity of Dryness
timeFrame: Week 8
measure: Product Acceptability and Preference Questionnaire - Severity of Burning
timeFrame: Week 1, Week 2
measure: Product Acceptability and Preference Questionnaire - Severity of Burning
timeFrame: Week 8
measure: Product Acceptability and Preference Questionnaire - Severity of Itching
timeFrame: Week 1, Week 2
measure: Product Acceptability and Preference Questionnaire - Severity of Itching
timeFrame: Week 8
measure: Product Acceptability and Preference Questionnaire - Severity of Scaling
timeFrame: Week 1, Week 2
measure: Product Acceptability and Preference Questionnaire - Severity of Scaling
timeFrame: Week 8
measure: Product Acceptability and Preference Questionnaire - Ease of Application of Product
timeFrame: Week 1, Week 2
measure: Product Acceptability and Preference Questionnaire - Ease of Application of Product
timeFrame: Week 8
measure: Product Acceptability and Preference Questionnaire - Comfort of Skin
timeFrame: Week 1, Week 2
measure: Product Acceptability and Preference Questionnaire - Comfort of Skin
timeFrame: Week 8
measure: Product Acceptability and Preference Questionnaire - Which Study Product is Subject More Satisfied With?
timeFrame: Week 1, Week 2
measure: Product Acceptability and Preference Questionnaire - Comparison of Study Products to Products Used in the Past
timeFrame: Week 8
measure: Product Acceptability and Preference Questionnaire - Decrease of Acne Breakouts by Study Products
timeFrame: Week 1, Week 2
measure: Product Acceptability and Preference Questionnaire - Decrease of Acne Breakouts by Study Products
timeFrame: Week 8
measure: Product Acceptability and Preference Questionnaire - Compliance
timeFrame: Week 1, Week 2
measure: Product Acceptability and Preference Questionnaire - Compliance
timeFrame: Week 8
measure: Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin
timeFrame: Week 1, Week 2
measure: Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin
timeFrame: Week 8
measure: Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment
timeFrame: Week 1, Week 2
measure: Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment
timeFrame: Week 8
measure: Product Acceptability and Preference Questionnaire - Ease of Use With Make-Up
timeFrame: Week 1, Week 2
measure: Product Acceptability and Preference Questionnaire - Ease of Use With Make-Up
timeFrame: Week 8
measure: Product Acceptability and Preference Questionnaire - Overall Satisfaction of Study Product
timeFrame: Week 1, Week 2
measure: Product Acceptability and Preference Questionnaire - Overall Satisfaction of Study Product
timeFrame: Week 8
Other outcomes:
Locations:
city: Rockville
country: United States
facility: Aesthetics, Skin Care & Dermasurgery
state: Maryland
city: Warren
country: United States
facility: Grekin Skin Institute
state: Michigan
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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. J Cosmet Dermatol. 2012 Dec;11(4):251-60. doi: 10.1111/jocd.12013.