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

NCT ID: NCT00757523

Last Updated: 2017-08-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 382 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-10
• Study Completion Date: 2009-06-24

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.

Conditions

Acne Vulgaris

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Epiduo Gel

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

Group Type: ACTIVE_COMPARATOR

Epiduo Gel

Intervention Type: 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

Duac Gel

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

Group Type: EXPERIMENTAL

Duac Gel

Intervention Type: 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

Interventions

Epiduo Gel

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

Intervention Type: DRUG

Duac Gel

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

Intervention Type: DRUG

Other Intervention Names

Duac Akne Gel

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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: collaborator

Stiefel, a GSK Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Berlin, , Germany

GSK Investigational Site

Berlin, , Germany

GSK Investigational Site

Bonn, , Germany

GSK Investigational Site

Dessau, , Germany

GSK Investigational Site

Dülmen, , Germany

GSK Investigational Site

Essen, , Germany

GSK Investigational Site

Frankfurt, , Germany

GSK Investigational Site

Giessen, , Germany

GSK Investigational Site

Halle, , Germany

GSK Investigational Site

Hamburg, , Germany

GSK Investigational Site

Kiel, , Germany

GSK Investigational Site

Landau, , Germany

GSK Investigational Site

Magdeburg, , Germany

GSK Investigational Site

München, , Germany

GSK Investigational Site

München, , Germany

GSK Investigational Site

Münster, , Germany

GSK Investigational Site

Potsdam, , Germany

Countries

Germany

References

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.

Reference Type: RESULT

PMID: 19911678 (View on PubMed)

Other Identifiers

S194-401

Identifier Type: -

Identifier Source: org_study_id