Evaluation of the Effectiveness, Safety, and Tolerability of Duac Akne Gel and Epiduo Gel in the Treatment of Facial Acne Vulgaris

NCT00757523 | Completed Phase 4

• 1 other identifier: S194-401
• Study Type: interventional
• Target: 382
• Locations: 1 country
• Sites: 17

Brief Summary

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

Conditions

Acne Vulgaris

Keywords

Acne Vulgaris; Akne; Acne; Akne Vulgaris

Outcome Measures

Primary Outcomes (1)

• Percent change in inflammatory lesion count from Baseline to 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.

  Baseline (Day 1) and Week 12

Secondary Outcomes (18)

• 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

• Percent change in total lesion count from Baseline to week 12

  Baseline (Day 1) and 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 inflammatory lesion count from Baseline to Week 12.

  Baseline (Day 1) and Week 12

Study Arms (2)

Epiduo Gel

ACTIVE COMPARATOR

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

Drug: Epiduo Gel

Duac Gel

EXPERIMENTAL

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

Drug: Duac Gel

Interventions

Epiduo Gel DRUG

Epiduo Gel (combination of 0.1% adapalene and 2.5% benzoyl peroxide (BPO) in a gel preparation). Treatments administered once-daily in the evening for 12 weeks

Epiduo Gel

Duac Gel DRUG

Duac Akne Gel (combination of 1% clindamycin phosphate and 5% benzoyl peroxide (BPO) in a gel preparation). Treatments administered once-daily in the evening for 12 weeks

Also known as: Duac Akne Gel

Duac Gel

Eligibility Criteria

• Age: 12 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stiefel, a GSK Company: lead
• GlaxoSmithKline: collaborator

Study Sites (17)

GSK Investigational Site

Berlin, 14052, Germany

Location

GSK Investigational Site

Berlin, 14169, Germany

Location

GSK Investigational Site

Bonn, 53105, Germany

Location

GSK Investigational Site

Dessau, 06847, Germany

Location

GSK Investigational Site

Dülmen, 48249, Germany

Location

GSK Investigational Site

Essen, 45122, Germany

Location

GSK Investigational Site

Frankfurt, 60590, Germany

Location

GSK Investigational Site

Giessen, 35392, Germany

Location

GSK Investigational Site

Halle, 06097, Germany

Location

GSK Investigational Site

Hamburg, 20246, Germany

Location

GSK Investigational Site

Kiel, 24148, Germany

Location

GSK Investigational Site

Landau, 76829, Germany

Location

GSK Investigational Site

Magdeburg, 39120, Germany

Location

GSK Investigational Site

München, 80337, Germany

Location

GSK Investigational Site

München, 80802, Germany

Location

GSK Investigational Site

Münster, 48149, Germany

Location

GSK Investigational Site

Potsdam, 14469, Germany

Location

Related Publications (1)

• 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.

  PMID: 19911678 RESULT

MeSH Terms

Conditions

Acne Vulgaris

Interventions

clindamycin phosphate benzoyl peroxide combination

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2008
• First Posted: September 23, 2008
• Study Start: September 10, 2008
• Primary Completion: April 24, 2009
• Study Completion: June 24, 2009
• Last Updated: August 17, 2017

Record last verified: 2017-08

Locations

DE (17)