Clinical trial NCT00887484: A Comparative Study of the Tolerability of Two Combination Therapies for the Treatment of Acne
Official title: A Single-blind, Randomized, Comparative Pilot Study Evaluating the Tolerability of Two Topical Combination Therapies in the Treatment of Acne Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acne Vulgaris
Keywords: Acne
Acne Vulgaris
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
First posted: 2009-04-24
Enrollment: 50
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the tolerability of topical combination therapies in the treatment of facial acne.

Detailed description: The purpose of this study is to compare the tolerability of topical combination therapies in the treatment of facial acne.

Eligibility criteria: Inclusion Criteria:

* Male or female subjects at least 21 years of age, in good general health with documented diagnosis of acne vulgaris.
* Female subjects of childbearing potential must have a negative pregnancy test. Sexually active women of childbearing potential participating in the study must use a medically acceptable form of contraception Abstinence is considered an acceptable method of contraception.
* Inflammatory (papules and pustules) and non-inflammatory (open and closed comedones) facial lesions.
* The ability and willingness to follow all study procedures, attend all scheduled visits, and successfully complete the study
* Capable of understanding and willing to provide signed and dated written voluntary informed consent (and any local or national authorization requirements) 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 other than acne vulgaris.
* History or presence of regional enteritis or inflammatory bowel disease (eg, ulcerative colitis, pseudomembranous colitis, chronic diarrhea, or a history of antibiotic-associated colitis) or similar symptoms.
* Use of topical antibiotics or anti-acne medications 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.
* Facial procedures performed by an esthetician, beautician, physician, nurse, or other practitioner, within the past 4 weeks or during the conduct of the study.
* Known hypersensitivity or previous allergic reaction to any of the active components, lincomycin, adapalene, clindamycin, benzoyl peroxide or excipients of the study product.

Primary outcomes:
measure: Erythema (Redness)
timeFrame: Weeks 1 and 2
measure: Skin Dryness
timeFrame: Weeks 1 and 2
measure: Skin Peeling
timeFrame: Weeks 1 and 2
measure: Irritant/Allergic Contact Dermatitis
timeFrame: Weeks 1 and 2
Secondary outcomes:
measure: Erythema (Redness)
timeFrame: Weeks 5 and 8
measure: Skin Dryness
timeFrame: Weeks 5 and 8
measure: Skin Peeling
timeFrame: Weeks 5 and 8
measure: Irritant/Allergic Contact Dermatitis
timeFrame: Weeks 5 and 8
measure: Investigators Static Global Assessment
timeFrame: Baseline, Weeks 5, 8
measure: Total Acne Lesion Counts
timeFrame: Baseline, Weeks 5 and 8
measure: Inflammatory Acne Lesion Counts
timeFrame: Baseline, Weeks 5 and 8
measure: Non-inflammatory Acne Lesion Counts
timeFrame: Baseline, Weeks 5 and 8
measure: Skindex-29 Quality of Life Questionnaire (QoL) - Symptomatic Domain
timeFrame: Baseline, Weeks 2 and 8
measure: Quality of Life Questionnaire - Emotional Domain
timeFrame: Baseline, Weeks 2 and 8
measure: Quality of Life Questionnaire - Functional Domain
timeFrame: Baseline, Weeks 2 and 8
measure: Quality of Life Questionnaire - Global Score
timeFrame: Baseline, Weeks 2 and 8
measure: Product Acceptability and Preference Questionnaire - Severity of Redness at Weeks 1 and 2
timeFrame: Weeks 1 and 2
measure: Product Acceptability and Preference Questionnaire - Severity of Redness at Week 8
timeFrame: Week 8
measure: Product Acceptability and Preference Questionnaire - Severity of Dryness at Weeks 1 and 2
timeFrame: Weeks 1 and 2
measure: Product Acceptability and Preference Questionnaire - Severity of Dryness at Week 8
timeFrame: Week 8
measure: Product Acceptability and Preference Questionnaire - Severity of Burning at Weeks 1 and 2
timeFrame: Weeks 1 and 2
measure: Product Acceptability and Preference Questionnaire - Severity of Burning at Week 8
timeFrame: Week 8
measure: Product Acceptability and Preference Questionnaire - Severity of Itching at Weeks 1 and 2
timeFrame: Weeks 1 and 2
measure: Product Acceptability and Preference Questionnaire - Severity of Itching at Week 8
timeFrame: Week 8
measure: Product Acceptability and Preference Questionnaire - Severity of Scaling at Weeks 1 and 2
timeFrame: Weeks 1 and 2
measure: Product Acceptability and Preference Questionnaire - Severity of Scaling at Week 8
timeFrame: Week 8
measure: Product Acceptability and Preference Questionnaire - Ease of Application of Product at Weeks 1 and 2
timeFrame: Weeks 1 and 2
measure: Product Acceptability and Preference Questionnaire - Ease of Application of Product at Week 8
timeFrame: Week 8
measure: Product Acceptability and Preference Questionnaire - Comfort of Skin at Weeks 1 and 2
timeFrame: Weeks 1 and 2
measure: Product Acceptability and Preference Questionnaire - Comfort of Skin at Week 8
timeFrame: Week 8
measure: Product Acceptability and Preference Questionnaire - Which Study Product is Subject More Satisfied With? at Weeks 1 and 2
timeFrame: Weeks 1 and 2
measure: Product Acceptability and Preference Questionnaire - Comparison of Study Products Used in the Past at Week 8
timeFrame: Week 8
measure: Product Acceptability and Preference Questionnaire - Decrease of Acne Breakouts by Study Products at Weeks 1 and 2
timeFrame: Weeks 1 and 2
measure: Product Acceptability and Preference Questionnaire - Decrease of Acne Breakouts by Study Products at Week 8
timeFrame: Week 8
measure: Product Acceptability and Preference Questionnaire - Compliance at Weeks 1 and 2
timeFrame: Weeks 1 and 2
measure: Product Acceptability and Preference Questionnaire - Compliance at Week 8
timeFrame: Week 8
measure: Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin at Weeks 1 and 2
timeFrame: Weeks 1 and 2
measure: Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin at Week 8
timeFrame: Week 8
measure: Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment at Week 1 and 2
timeFrame: Weeks 1 and 2
measure: Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment at Week 8
timeFrame: Week 8
measure: Product Acceptability and Preference Questionnaire - Ease of Use Wtih Make-Up at Weeks 1 and 2
timeFrame: Weeks 1 and 2
measure: Product Acceptability and Preference Questionnaire - Ease of Use With Make-Up at Week 8
timeFrame: Week 8
measure: Product Acceptability and Preference Questionnaire - Overall Satisfaction of Study Product at Weeks 1 and 2
timeFrame: Weeks 1 and 2
measure: Product Acceptability and Preference Questionnaire - Overall Satisfaction of Study Product at Week 8
timeFrame: Week 8
Other outcomes:
Locations:
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Centro de Investigación y Prevencion de Enfermidades Cardiovasculares
state: Buenos Aires
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires
state: Buenos Aires
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: LUMIPIEL - Centro Dermatológico
state: Buenos Aires
city: Ciudad de Buenos Aires
country: Argentina
facility: Buenos Aires Skin
state: Buenos Aires
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: