A Study to Evaluate Tolerability of Two Topical Drug Products in the Treatment of Facial Acne
Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acne Vulgaris
Intervention: Clindamycin and benzoyl peroxide gel (Duac® Topical Gel) (Drug); benzoyl peroxide and adapalene gel (EPIDUO™ Gel) (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Stiefel, a GSK Company Official(s) and/or principal investigator(s): GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Skin Dryness ScoreSkin Peeling Score Irritant/Allergic Contact Dermatitis Score Erythema (Redness) Score
Secondary outcome: Erythema (Redness) ScoreSkin Dryness Score Skin Peeling Score Irritant/Allergic Contact Dermatitis Score Investigator Static Global Assessment Score Inflammatory Acne Lesion Counts Non-Inflammatory Acne Lesion Counts Total Acne Lesion Counts Skindex-29 Quality of Life Questionnaire - Symptomatic Domain Skindex-29 Quality of Life Questionnaire - Emotional Domain Skindex-29 Quality of Life Questionnaire - Functional Domain Skindex-29 Quality of Life Questionnaire - Global Score Product Acceptability and Preference Questionnaire - Severity of Redness Product Acceptability and Preference Questionnaire - Severity of Redness Product Acceptability and Preference Questionnaire - Severity of Dryness Product Acceptability and Preference Questionnaire - Severity of Dryness Product Acceptability and Preference Questionnaire - Severity of Burning Product Acceptability and Preference Questionnaire - Severity of Burning Product Acceptability and Preference Questionnaire - Severity of Itching Product Acceptability and Preference Questionnaire - Severity of Itching Product Acceptability and Preference Questionnaire - Severity of Scaling Product Acceptability and Preference Questionnaire - Severity of Scaling Product Acceptability and Preference Questionnaire - Ease of Application of Product Product Acceptability and Preference Questionnaire - Ease of Application of Product Product Acceptability and Preference Questionnaire - Comfort of Skin Product Acceptability and Preference Questionnaire - Comfort of Skin Product Acceptability and Preference Questionnaire - Which Study Product is Subject More Satisfied With? Product Acceptability and Preference Questionnaire - Comparison of Study Products to Products Used in the Past Product Acceptability and Preference Questionnaire - Decrease of Acne Breakouts by Study Products Product Acceptability and Preference Questionnaire - Decrease of Acne Breakouts by Study Products Product Acceptability and Preference Questionnaire - Compliance Product Acceptability and Preference Questionnaire - Compliance Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment Product Acceptability and Preference Questionnaire - Ease of Use With Make-Up Product Acceptability and Preference Questionnaire - Ease of Use With Make-Up Product Acceptability and Preference Questionnaire - Overall Satisfaction of Study Product Product Acceptability and Preference Questionnaire - Overall Satisfaction of Study Product
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Aesthetics, Skin Care & Dermasurgery, Rockville, Maryland 20850, United States
Grekin Skin Institute, Warren, Michigan 48088, United States
Additional Information
Related 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. J Cosmet Dermatol. 2012 Dec;11(4):251-60. doi: 10.1111/jocd.12013.
Starting date: July 2009
Last updated: May 14, 2015
|