Comparison of Epiduo Associated With Lymecycline Versus Epiduo Vehicle Associated With Lymecycline in Acne Vulgaris
NCT ID: NCT01014689
Last Updated: 2021-02-18
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
378 participants
INTERVENTIONAL
2009-08-31
2010-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The purpose of this study is to demonstrate the efficacy of Adapalene 0.1% / Benzoyl Peroxide (BPO) 2.5% Gel associated with Lymecycline 300mg Capsules compared to Adapalene 0.1% /Benzoyl Peroxide 2.5% Vehicle Gel associated with Lymecycline 300mg Capsules, in the treatment of moderate to severe acne vulgaris.
The safety of the two treatment regimens will also be evaluated.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Efficacy & Safety Comparison of Epiduo With Doxycycline Versus Vehicle With Isotretinoin in the Treatment of Severe Acne
NCT01474590
Adapalene-Benzoy Peroxide (BPO) Gel in the Treatment of Acne Vulgaris as a 6-month Maintenance
NCT00687908
Adapalene-BPO Gel Associated With Doxycycline Hyclate 100 mg in the Treatment of Severe Acne Vulgaris
NCT00688064
A Study to Demonstrate the Efficacy and Safety of Adapalene/Benzoyl Peroxide Topical Gel in Subjects With Acne Vulgaris
NCT00421993
Study to Compare the Safety and Efficacy of IDP-126 Gel to Epiduo® Forte Gel and Vehicle Gel
NCT04892706
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Adapalene 0.1% / BPO 2.5% gel
Adapalene/ BPO gel with Lymecycline capsules
Gel: Topical to the face, once daily in the evening Capsule: 1 capsule once daily in the morning
Adapalene 0.1% / BPO 2.5% Vehicle Gel
Adapalene/ BPO vehicle gel with Lymecycline capsules
Gel: Topical to the face, once daily in the evening Capsule: 1 capsule once daily in the morning
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Adapalene/ BPO gel with Lymecycline capsules
Gel: Topical to the face, once daily in the evening Capsule: 1 capsule once daily in the morning
Adapalene/ BPO vehicle gel with Lymecycline capsules
Gel: Topical to the face, once daily in the evening Capsule: 1 capsule once daily in the morning
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Subjects with moderate to severe facial acne vulgaris (Investigator's Global Assessment score of 3 or 4),
Exclusion Criteria
2. Subjects with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.),
3. Subjects with a wash-out period for topical treatment on the face less than: Corticosteroids, antibiotics, antibacterials, antiseptics, retinoids, other anti-inflammatory drugs or other acne treatments (2 weeks), Zinc containing drugs (1 week), Phototherapy devices for acne and cosmetic procedures (1 week)
4. Subjects with a wash-out period for systemic treatment less than:Acne therapy containing zinc (4 weeks), Corticosteroids, antibiotics (4 weeks), Other acne treatments (6 months), Ciproterone acetate / Chlormadinone acetate (6 months), Spironolactone / Drospirenone (3 months)
5. Subjects with impaired hepatic (ALT/AST \> 3xULN and bilirubin \> 1.5xULN) or renal (creatinine clearance greater than 60 ml/min) functions based on a blood sample,
6. Subjects with known intolerance to lactose,
12 Years
35 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Galderma R&D
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Florence Paliargues
Role: STUDY_DIRECTOR
Galderma R&D
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Galderma Investigator site
Canberra, , Australia
Galderma Investigator site
Kogarah, , Australia
Galderma Investigator site
Melbourne, , Australia
Galderma Investigator site
Sydney, , Australia
Galderma Investigator site
Brussels, , Belgium
Galderma Investigator site
Ghent, , Belgium
Galderma Investigator site
Leuven, , Belgium
Galderma Investigator site
Belo Horizonte, , Brazil
Galderma Investigator site
São Paulo, , Brazil
Galderma Investigator site
Bordeaux, , France
Galderma Investigator site
Cannes, , France
Galderma Investigator site
Martigues, , France
Galderma Investigator site
Nantes, , France
Galderma Investigator site
Pantin, , France
Galderma Investigator site
Pierre-Bénite, , France
Galderma Investigator site
Cuxhaven, , Germany
Galderma Investigator site
Darmstadt, , Germany
Galderma Investigator site
Frankfurt, , Germany
Galderma Investigator site
Catania, , Italy
Galderma Investigator site
Ferrara, , Italy
Galderma Investigator site
Mexico City, , Mexico
Galderma Investigator site
Monterrey, , Mexico
Galderma Investigator site
Tlalnepantla, , Mexico
Galderma Investigator site
Zapopan, , Mexico
Galderma Investigator site
Lodz, , Poland
Galderma Investigator site
Eskilstuna, , Sweden
Galderma Investigator site
Farsta, , Sweden
Galderma Investigator site
Hägersten, , Sweden
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
RD.03.SPR.29080
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.