A Study to Evaluate Tolerability of Two Topical Drug Products in the Treatment of Facial Acne

Stiefel, a GSK Company28 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Acne Vulgaris

Interventions

Clindamycin and benzoyl peroxide gel (Duac® Topical Gel)DRUG

Subjects will apply Duac(clindamycin and benzoyl peroxide) gel to one-half of their face and and apply Epiduo (benzoyl peroxide/adapalene) gel on the other side of their face once a day for the first 2 weeks. Starting at week 2, subjects will apply Duac (benzoyl peroxide/clindamycin gel) to the entire face for an additional 6 weeks.

benzoyl peroxide and adapalene gel (EPIDUO™ Gel)DRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 (2)

Aesthetics, Skin Care & Dermasurgery

Rockville, Maryland, United States

Grekin Skin Institute

Warren, Michigan, United States

Outcomes

Primary Outcomes

Skin Dryness Score

Investigator assessment of tolerability (skin dryness) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.

Time frame: Week 1, Week 2

Skin Peeling Score

Investigator assessment of tolerability (skin peeling) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; Intense, 3.

Time frame: Week 1, Week 2

Irritant/Allergic Contact Dermatitis Score

Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis) on the face. Erythema,peeling, and dryness were graded using the following scale: 0 None 1. Slight 2. Moderate 3. Intense

Time frame: Week 1, Week 2

Erythema (Redness) Score

Investigator assessment of tolerability (irritant/allergic contact dermatitis) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.

Time frame: Week 1, Week 2

Secondary Outcomes

Erythema (Redness) Score

Investigator assessment of tolerability (erythema) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.

Time frame: Week 5, Week 8

Skin Dryness Score

Data from ClinicalTrials.gov

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Time frame: Week 5, Week 8

Skin Peeling Score

Time frame: Week 5, Week 8

Irritant/Allergic Contact Dermatitis Score

Investigator assessment of tolerability (contact dermatitis) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.

Time frame: Week 5, Week 8

Investigator Static Global Assessment Score

ISGA is evaluated using the following scale: 0, clear, clear skin with no lesions; 1, almost clear, rare non-inflammatory lesions; 2, mild, some non-inflammatory lesions with no more than a few inflammatory lesions but no nodular lesions; 3, moderate, up to many non-inflammatory lesions and may have some inflammatory lesions, but no more than 1 small nodular lesion; 4, severe, up to many non-inflammatory and inflammatory lesions, but no more than a few nodular lesions; 5, very severe, many non-inflammatory and inflammatory lesions and more than a few nodular lesions. May have cystic lesions.

Time frame: Week 5, Week 8

Inflammatory Acne Lesion Counts

Total number of inflammatory acne lesions (pustules, papules) at each timepoint.

Time frame: Week 5, Week 8

Non-Inflammatory Acne Lesion Counts

Total number of non-inflammatory acne lesions (whiteheads and blackheads) at each timepoint.

Time frame: Week 5, Week 8

Total Acne Lesion Counts

Total acne lesion counts - includes both inflammatory acne lesions (pustules, papules), noninflammatory lesions (whiteheads and blackheads),

Time frame: Week 5, Week 8

Skindex-29 Quality of Life Questionnaire - Symptomatic Domain

Skindex-29 Quality of Life (QoL) Questionnaire used in dermatological disease consisting of 29 questions covering: burden of symptoms, functioning and emotional domains, with a five-point scale from: "never" to "all the time", higher scores for each domain indicate worse effects on QoL. Scores range from 0 to 100. Higher scores indicate worse QoL for that domain.

Time frame: Baseline, and Week 8

Skindex-29 Quality of Life Questionnaire - Emotional Domain

Skindex-29 Quality of Life (QoL)Questionnaire used in dermatological disease consisting of 29 questions covering: burden of symptoms, functioning and emotional domains, with a five-point scale from: "never" to "all the time", higher scores for each domain indicate worse effects on QoL. Scores range from 0 to 100. Higher scores indicate worse QoL for that domain.

Time frame: Baseline, and Week 8

Skindex-29 Quality of Life Questionnaire - Functional Domain

Skindex-29 Quality of Life (QoL)Questionnaire used in dermatological disease consisting of 29 questions covering: burden of symptoms, functioning and emotional domains, with a five-point scale from: "never" to "all the time", higher scores for each domain indicate worse effects on QoL. Scores range from 0 to 100. Higher scores indicate worse QoL for that domain.

Time frame: Baseline, and Week 8

Skindex-29 Quality of Life Questionnaire - Global Score

Skindex-29 Quality of Life (QoL)Questionnaire used in dermatological disease consisting of 29 questions covering: burden of symptoms, functioning and emotional domains, with a five-point scale from: "never" to "all the time", higher scores for each domain indicate worse effects on QoL. The Global Score ranges from 0 to 100. Higher scores indicate worse QoL for that domain.

Time frame: Baseline, and Week 8

Product Acceptability and Preference Questionnaire - Severity of Redness