Evaluation of the Effectiveness, Safety, and Tolerability of Duac Akne Gel and Epiduo Gel in the Treatment of Facial Acne Vulgaris
Information source: Stiefel Laboratories
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acne Vulgaris
Intervention: Epiduo Gel (Drug); Duac Gel (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Stiefel Laboratories Official(s) and/or principal investigator(s):
David G Angulo, MD, Study Director, Affiliation: Stiefel Labortories, Inc., Sr. Director Global Clinical Research
Christos Zouboulis, MD, Principal Investigator, Affiliation: Departments of Dermatology, Venreology, Allergology and Immunology, Dessau Medical Centre
Summary
The purpose of this study is to compare the effectiveness of two marketed products in
subjects with facial acne vulgaris
Clinical Details
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 design: Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Efficacy Study
Primary outcome: Outcome Measure:
To evaluate the efficacy of Duac Akne Gel compared with Epiduo Gel in the treatment of facial acne vulgaris.
Secondary outcome: Outcome Measure:
To evaluate the safety and tolerability of Duac Akne Gel compared with Epiduo 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
Minimum age: 12 Years.
Maximum age: 45 Years.
Gender(s): Both.
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.
Locations and Contacts
Departments of Dermatology, Venreology, Allergology and Immunology, Dessau Medical Centre, Dessau 06847, Germany; Recruiting
Mrs. Schmalle, Phone: 34 05 01 40 00, Email: sabine.schmalle@klinikum-dessau.de
Dietrich Trebing, MD, Principal Investigator
Universitatsklinik Hamburg, Hamburg 20246, Germany; Recruiting
Katrin Baade, Phone: 4940428038681, Email: k.baade@uke.uni-hamburg.de
Matthias Augustin, MD, Principal Investigator
Department of Dermatology & Allergy, Bonn 53105, Germany; Recruiting
Dagmar Wilsmann-Theis, MD, Phone: 4922828715370, Email: dagmar.wilsmann-theis@ukb.uni-bonn.de
Thomas Bieber, MD, Principal Investigator
Dr Bockhorst/Dr Dominicus Practice, Duelmen 48249, Germany; Recruiting
Stephanie Hoelscher, Phone: 492594909713, Email: praxis@hautzentrum-duelmen.de
Joachim Bockhorst, MD, Principal Investigator
Hautarzt Allergologe, Kiel 24148, Germany; Recruiting
Harald Bruening, MD, Phone: 49431726064, Email: Dr.H.Bruening@gmx.de
Harald Brüning, MD, Principal Investigator
Skin & Laser Centre Potsdam, Potsdam 14469, Germany; Recruiting
Anja Klein, MD, Phone: 493316256663, Email: klein@hlcp.de
Tanja C Fischer, MD, Principal Investigator
Hautaerzte and Laserzenrtrum Dr Fritz, Landau and Kandel, Landau 76829, Germany; Recruiting
Stephanie Metz, Phone: 49634120006, Email: DrKlausFritz@t-online.de
Klaus Fritz, MD, Principal Investigator
University Clinic Giessen/Germany - Psychodermatology,, Giessen 35392, Germany; Recruiting
Jörg Kupfer, MD, Phone: 496419945650, Email: Uwe.Gieler@psycho.med.uni-giessen.de
Uwe Gieler, MD, Principal Investigator
Department of Dermatology and Venereology, Magdeburg 39120, Germany; Recruiting
Anja Thielitz, MD, Phone: 493916715428, Email: anja.thielitz@med.ovgu.de
Harald Gollnick, MD, Principal Investigator
Praxis Dr Dirk Grone, Berlin 14052, Germany; Recruiting
Irene Marlaneschl, Phone: 4930887061206, Email: Imgr@gmx.de
Dirk Gröne, MD, Principal Investigator
Department of Dermatology, Venereology, and Allergology, University of Essen, Essen 45122, Germany; Not yet recruiting
Thomas Jansen, MD, Phone: 492017232325, Email: thomas.jansen@medizin.uni-essen.de
Thomas Jansen, MD, Principal Investigator
Department of Dermatology, University of Frankfurt, Frankfurt 60590, Germany; Recruiting
Matthias Hofmann, MD, Phone: 4969630183116, Email: matthias.hofmann@em.uni-frankfurt.de
Matthias Hofmann, MD, Principal Investigator
Klinik und Poliklinik fur Dermatologie und Allergologie der LMU, München 80337, Germany; Recruiting
Stephanie Steckmeier, MD, Phone: 498951606010, Email: Stephanie.steckmeier@med.uni-muenchen.de
Tatjana Pavicic, MD, Principal Investigator
Praxis für Dermatologie, Allergologie, Ästhetische Dermatologie ünd Naturheilverfahren, Berlin, 14169, Germany; Recruiting
Meike Schroder, MD, Phone: 030/8011424, Email: meike-schroeder@t-online.de
Meike Schröder, MD, Principal Investigator
Department of Dermatology, University of Munster, Münster 48149, Germany; Recruiting
Britta Bunselmeyer, Phone: 2518356558, Email: Britta.Bunselmeyer@ukmuenster.de
S Ständer, MD, Principal Investigator
Institute for Applied Dermatopharmacy, Centre for Clinical Trials Dermatology, Halle 06097, Germany; Recruiting
Claudia Richter, Phone: 493455573935, Email: claudia.richter@medizin.uni-halle.de
Johannes Wohlrab, MD, Principal Investigator
Dermatol Department Technical Univ. München, München 80802, Germany; Not yet recruiting
Isolde Hof, Phone: 49893182, Email: wolf-ingo.Worret@lrz.tum.de
Wolf-Ingo Worret, MD, Principal Investigator
Additional Information
Starting date: September 2008
Ending date: April 2009
Last updated: December 16, 2008
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