Clinical trial NCT00757523: Evaluation of the Effectiveness, Safety, and Tolerability of Duac Akne Gel and Epiduo Gel in the Treatment of Facial Acne Vulgaris
Official title: A Multi-center, Randomized, Evaluator-blind, Parallel-group Evaluation of the Efficacy, Safety, and Tolerability of Duac Akne Gel and Epiduo Gel in the Topical Treatment of Facial Acne Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acne Vulgaris
Keywords: Acne Vulgaris
Akne
Acne
Akne Vulgaris
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
First posted: 2008-09-23
Enrollment: 382
Sex: ALL
Minimum age (years): 12
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the effectiveness of two marketed products in subjects with facial acne vulgaris

Detailed description: Multiple physiopathological factors have been associated with acne vulgaris. Drug combinations are frequently used to address these factors and to improve efficacy in the treatment of acne. The current study proposes to compare a fixed-dose (once-daily) combination gel product containing benzoyl peroxide (BPO)and clindamycin against a fixed-dose (once-daily) combination gel product containing BPO and adapalene for the treatment of facial acne vulgaris.

Eligibility criteria: Inclusion Criteria:

* Males or females 12 to 45 years of age, inclusive, in good general health.
* Clinical diagnosis of acne vulgaris
* Capable of understanding and willing to provide signed and dated written voluntary informed consent
* Female subjects of childbearing potential must have a negative pregnancy test at baseline. Sexually active women of childbearing potential participating in the study must use a medically acceptable form of contraception
* Subjects who have been treated with estrogens, androgens, or anti-androgenic agents for more than 12 consecutive weeks prior to the first dose of study product are allowed to enroll as long as they do not expect to change dose, drug, or discontinue use during the study.
* The ability and willingness to follow all study procedures, attend all scheduled visits, and successfully complete the study.

Exclusion Criteria:

* Female subjects who are pregnant, trying to become pregnant, or who are lactating.
* Any clinically relevant finding at their baseline physical examination or medical history such as severe systemic diseases or 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 (eg, ulcerative colitis, pseudomembranous colitis, chronic diarrhea, or a history of antibiotic-associated colitis) or similar symptoms.
* Used topical antibiotics on the face or systemic antibiotics within the past 2 and 4 weeks, respectively.
* Used 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.
* Used systemic retinoids within the past 6 months.
* Using drugs known to be photosensitizers (eg, thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides) because of the possibility of increased phototoxicity.
* Using neuromuscular blocking agents. Clindamycin has neuromuscular blocking activities, which may enhance the action of other neuromuscular blocking agents.
* Used topical anti-acne medications (eg, BPO, retinoids, azelaic acid, resorcinol, salicylates, sulfacetamide sodium and derivatives, glycolic acid) within the past 2 weeks.
* Used any investigational therapy within 4 weeks of study day 1.
* Using the following types of facial products: astringents, toners, abradants, facials, peels containing glycolic or other acids, masks, washes or soaps containing BPO, sulfacetamide sodium or salicylic acid, non-mild facial cleansers, or moisturizers that contain retinol, salicylic acid, or α- or β-hydroxy acids.
* Using medications that are reported to exacerbate acne (eg, mega-doses of certain vitamins such as vitamin D, vitamin A, and vitamins B2, B6, and B12; haloperidol; halogens such as iodide and bromide; lithium; hydantoin; and phenobarbital) as these may impact efficacy assessments.
* Have had a facial procedure (chemical or laser peel, microdermabrasion, artificial ultraviolet \[UV\] therapy) performed by an esthetician, beautician, physician, nurse, or other practitioner, within the past 4 weeks.
* Have a known hypersensitivity or previous allergic reaction to any of the active components, lincomycin, adapalene, clindamycin, BPO, or excipients of the study medication.
* Employees of a clinical research organization involved in the study, or Stiefel Laboratories, or an immediate family member (partner, offspring, parents, siblings, or sibling's offspring) of an employee.
* Have a member of the same household in this trial.

Primary outcomes:
measure: Percent change in inflammatory lesion count from Baseline to Week 12
timeFrame: Baseline (Day 1) and Week 12
Secondary outcomes:
measure: Percentage of participants who achieved treatment success, defined as improvement of 2 grades or more in their Investigator Static Global Assessment (ISGA) acne severity scale from Baseline to Week 12
timeFrame: Week 12
measure: Time to 2-grade improvement in ISGA from Baseline
timeFrame: Week 12
measure: Percent change in total lesion count from Baseline to week 12
timeFrame: Baseline (Day 1) and Week 12
measure: Absolute change in inflammatory lesion count from Baseline to Weeks 1, 2, 4, 8
timeFrame: Baseline (Day 1) and Weeks 1, 2, 4, 8
measure: Absolute change in inflammatory lesion count from Baseline to Week 12.
timeFrame: Baseline (Day 1) and Week 12
measure: Absolute change in total lesion count from Baseline to Weeks 1, 2, 4, 8
timeFrame: Baseline (Day 1) and Weeks 1, 2, 4, 8
measure: Absolute change in total lesion count from Baseline to Week 12
timeFrame: Baseline (Day 1) and Week 12
measure: Percentage of participants who achieved treatment success from Baseline to Weeks 1, 2, 4, and 8
timeFrame: Weeks 1, 2, 4, and 8
measure: Absolute change in non-inflammatory lesion count from Baseline to Weeks 1 2, 4,8
timeFrame: Baseline (Day 1) and Weeks 1,2,4,8
measure: Absolute change in non-inflammatory lesion count from Baseline to Week 12
timeFrame: Baseline (Day 1) and Week 12
measure: Percent change in non-inflammatory lesion count from Baseline to Weeks 1, 2, 4, 8
timeFrame: Baseline (Day 1) and Weeks 1, 2, 4, 8
measure: Percent change in non-inflammatory lesion count from Baseline to Week 12
timeFrame: Baseline (Day 1) and Week 12
measure: Percent change in inflammatory lesion count from Baseline to Weeks 1, 2, 4, and 8
timeFrame: Baseline (Day 1) and Weeks 1, 2, 4, and 8
measure: Percent change in total lesion count from Baseline to Weeks 1, 2, 4, and 8
timeFrame: Baseline (Day 1) and Weeks 1, 2, 4, and 8
measure: Time to reach 50 percent reduction in inflammatory lesion counts from Baseline
timeFrame: Week 12
measure: Time to reach 50 percent reduction in non-inflammatory lesion counts from Baseline
timeFrame: Week 12
measure: Time to reach 50 percent reduction in total lesion counts from Baseline
timeFrame: Week 12
measure: Percentage of participants who had a Subject's Global Change Assessment score (SGAC) of 0 or 1 at Weeks 1, 2, 4, 8, and 12
timeFrame: Upto Week 12
Other outcomes:
Locations:
city: Berlin,
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Bonn
country: Germany
facility: GSK Investigational Site
city: Dessau
country: Germany
facility: GSK Investigational Site
city: Duelmen
country: Germany
facility: GSK Investigational Site
city: Essen
country: Germany
facility: GSK Investigational Site
city: Frankfurt
country: Germany
facility: GSK Investigational Site
city: Giessen
country: Germany
facility: GSK Investigational Site
city: Halle
country: Germany
facility: GSK Investigational Site
city: Hamburg
country: Germany
facility: GSK Investigational Site
city: Kiel
country: Germany
facility: GSK Investigational Site
city: Landau
country: Germany
facility: GSK Investigational Site
city: Magdeburg
country: Germany
facility: GSK Investigational Site
city: München
country: Germany
facility: GSK Investigational Site
city: München
country: Germany
facility: GSK Investigational Site
city: Münster
country: Germany
facility: GSK Investigational Site
city: Potsdam
country: Germany
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Zouboulis CC, Fischer TC, Wohlrab J, Barnard J, Alio AB. Study of the efficacy, tolerability, and safety of 2 fixed-dose combination gels in the management of acne vulgaris. Cutis. 2009 Oct;84(4):223-9.