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

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00757523
First received: September 21, 2008
Last updated: July 11, 2011
Last verified: July 2011
  Purpose

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


Condition Intervention Phase
Acne Vulgaris
Drug: Epiduo Gel
Drug: Duac Gel
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Outcome Measure: To evaluate the efficacy of Duac Akne Gel compared with Epiduo Gel in the treatment of facial acne vulgaris. [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Outcome Measure: To evaluate the safety and tolerability of Duac Akne Gel compared with Epiduo Gel. [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]

Enrollment: 400
Study Start Date: September 2008
Study Completion Date: June 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Epiduo Gel
Epiduo Gel (combination of 0.1% adapalene and 2.5% benzoyl peroxide (BPO) in a gel preparation).
Drug: 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
Other Name: Epiduo Gel
Experimental: Duac Gel 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
Other Name: Duac Akne Gel

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

Ages Eligible for Study:   12 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00757523

Locations
Germany
Praxis Dr Dirk Grone
Berlin, Germany, 14052
Praxis für Dermatologie, Allergologie, Ästhetische Dermatologie ünd Naturheilverfahren
Berlin,, Germany, 14169
Department of Dermatology & Allergy
Bonn, Germany, 53105
Departments of Dermatology, Venreology, Allergology and Immunology, Dessau Medical Centre
Dessau, Germany, 06847
Dr Bockhorst/Dr Dominicus Practice
Duelmen, Germany, 48249
Department of Dermatology, Venereology, and Allergology, University of Essen
Essen, Germany, 45122
Department of Dermatology, University of Frankfurt
Frankfurt, Germany, 60590
University Clinic Giessen/Germany - Psychodermatology,
Giessen, Germany, 35392
Institute for Applied Dermatopharmacy, Centre for Clinical Trials Dermatology
Halle, Germany, 06097
Universitatsklinik Hamburg
Hamburg, Germany, 20246
Hautarzt Allergologe
Kiel, Germany, 24148
Hautaerzte and Laserzenrtrum Dr Fritz, Landau and Kandel
Landau, Germany, 76829
Department of Dermatology and Venereology
Magdeburg, Germany, 39120
Dermatol Department Technical Univ. München
München, Germany, 80802
Klinik und Poliklinik fur Dermatologie und Allergologie der LMU
München, Germany, 80337
Department of Dermatology, University of Munster
Münster, Germany, 48149
Skin & Laser Centre Potsdam
Potsdam, Germany, 14469
Sponsors and Collaborators
Stiefel, a GSK Company
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
Principal Investigator: Christos Zouboulis, MD Departments of Dermatology, Venreology, Allergology and Immunology, Dessau Medical Centre
  More Information

Publications:
Responsible Party: Cheri A. Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00757523     History of Changes
Other Study ID Numbers: S194 -401, Eudract No 2008-002359-26, The 'Duetta' study
Study First Received: September 21, 2008
Last Updated: July 11, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by GlaxoSmithKline:
Acne
Acne Vulgaris
Akne
Akne Vulgaris

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases
Benzoyl Peroxide
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014