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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 Score

Skin Peeling Score

Irritant/Allergic Contact Dermatitis Score

Erythema (Redness) Score

Secondary outcome:

Erythema (Redness) Score

Skin 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

Page last updated: August 20, 2015

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