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

Stiefel, a GSK Company1 site in 1 country382 target enrollmentSeptember 10, 2008

ConditionsAcne Vulgaris

InterventionsEpiduo Gel Duac Gel

DrugsEpiduo Gel Duac Gel

Overview

Phase: Phase 4
Intervention: Epiduo Gel
Conditions: Acne Vulgaris
Sponsor: Stiefel, a GSK Company
Enrollment: 382
Locations: 1
Primary Endpoint: Percent change in inflammatory lesion count from Baseline to Week 12
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 10, 2008

End Date

June 24, 2009

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Stiefel, a GSK Company

Responsible Party

Sponsor

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.

Arms & Interventions

Epiduo Gel

Epiduo Gel (combination of 0.1% adapalene and 2.5% benzoyl peroxide (BPO) in a gel preparation).

Intervention: Epiduo Gel

Duac Gel

Duac Akne Gel (combination of 1% clindamycin phosphate and 5% benzoyl peroxide (BPO) in a gel preparation).

Intervention: Duac Gel

Outcomes

Primary Outcomes

Percent change in inflammatory lesion count from Baseline to Week 12

Time Frame: Baseline (Day 1) and Week 12

The efficacy assessor performed a count of inflammatory lesions (papules and pustules, including nasal lesions) each study visit. Lesion counts were confined to the face. Baseline was defined as the value at Day 1 (Visit 1). Change from Baseline was calculated by subtracting the Baseline from the post-randomization value at Week 12.

Secondary Outcomes

Percent change in total lesion count from Baseline to week 12(Baseline (Day 1) and Week 12)
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(Week 12)
Time to 2-grade improvement in ISGA from Baseline(Week 12)
Absolute change in inflammatory lesion count from Baseline to Week 12.(Baseline (Day 1) and Week 12)
Absolute change in non-inflammatory lesion count from Baseline to Weeks 1 2, 4,8(Baseline (Day 1) and Weeks 1,2,4,8)
Absolute change in non-inflammatory lesion count from Baseline to Week 12(Baseline (Day 1) and Week 12)
Time to reach 50 percent reduction in non-inflammatory lesion counts from Baseline(Week 12)
Absolute change in inflammatory lesion count from Baseline to Weeks 1, 2, 4, 8(Baseline (Day 1) and Weeks 1, 2, 4, 8)
Absolute change in total lesion count from Baseline to Weeks 1, 2, 4, 8(Baseline (Day 1) and Weeks 1, 2, 4, 8)
Absolute change in total lesion count from Baseline to Week 12(Baseline (Day 1) and Week 12)
Percentage of participants who achieved treatment success from Baseline to Weeks 1, 2, 4, and 8(Weeks 1, 2, 4, and 8)
Percent change in non-inflammatory lesion count from Baseline to Weeks 1, 2, 4, 8(Baseline (Day 1) and Weeks 1, 2, 4, 8)
Percent change in non-inflammatory lesion count from Baseline to Week 12(Baseline (Day 1) and Week 12)
Percent change in inflammatory lesion count from Baseline to Weeks 1, 2, 4, and 8(Baseline (Day 1) and Weeks 1, 2, 4, and 8)
Percent change in total lesion count from Baseline to Weeks 1, 2, 4, and 8(Baseline (Day 1) and Weeks 1, 2, 4, and 8)
Time to reach 50 percent reduction in inflammatory lesion counts from Baseline(Week 12)
Time to reach 50 percent reduction in total lesion counts from Baseline(Week 12)
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(Upto Week 12)