Adapalene-BPO Gel in the Treatment of Acne Vulgaris as a 6-month Maintenance
Summary
The purpose of this study is to demonstrate the efficacy of Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel compared to its Vehicle Gel as an acne maintenance treatment in Subjects previously treated with Adapalene-BPO Gel or Adapalene-BPO Vehicle Gel both associated with Doxycycline Hyclate 100 mg. The safety of the two investigational treatments will also be assessed.
Description
This study is a follow-up to RD.03.SPR.29074 - ACCESS I - "Adapalene-BPO Gel Associated With Doxycycline 100 mg in the Treatment of Severe Acne Vulgaris"
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Conditions
Acne
Intervention
Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel, Vehicle Gel
Location
Galderma Investigational Site
San Diego
California
United States
77598
Status
Completed
Source
Galderma
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00687908
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Benzoyl Peroxide
A peroxide derivative that has been used topically for BURNS and as a dermatologic agent in the treatment of ACNE and POISON IVY DERMATITIS. It is used also as a bleach in the food industry.
Acneiform Eruptions
Visible efflorescent lesions of the skin caused by acne or resembling acne. (Dorland, 28th ed, p18, 575)
Enterobactin
An iron-binding cyclic trimer of 2,3-dihydroxy-N-benzoyl-L-serine. It is produced by E COLI and other enteric bacteria.
Glucose Oxidase
An enzyme of the oxidoreductase class that catalyzes the conversion of beta-D-glucose and oxygen to D-glucono-1,5-lactone and peroxide. It is a flavoprotein, highly specific for beta-D-glucose. The enzyme is produced by Penicillium notatum and other fungi and has antibacterial activity in the presence of glucose and oxygen. It is used to estimate glucose concentration in blood or urine samples through the formation of colored dyes by the hydrogen peroxide produced in the reaction. (From Enzyme Nomenclature, 1992) EC 1.1.3.4.
Enoximone
1,3-Dihydro-4-methyl-5-(4-(methylthio)benzoyl)-2H-imidazol-2-one. A selective phosphodiesterase inhibitor with vasodilating and positive inotropic activity that does not cause changes in myocardial oxygen consumption. It is used in patients with congestive heart failure.
Clinical Trials
This is a multi-center, randomized, double-blind, parallel group study with 12 weeks of treatment of acne vulgaris. Efficacy and safety evaluations will be performed at Screening (safety...
The purpose of this study is to evaluate the safety and efficacy of Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% administered once daily for up to 12 weeks in subjects 9 to 11 y...
The purpose of this study is to demonstrate the non-inferior efficacy of Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel when compared to Clindamycin 1% / Benzoyl Peroxide 5% Gel in Subjects wi...
The purpose of this study is to compare the safety and efficacy of 5% Dapsone Topical Gel, (DTG) twice daily in combination with once daily vehicle control, adapalene gel 0.1% or benzoyl p...
The purpose of this study is to demonstrate the efficacy of Adapalene 0.1% / Benzoyl Peroxide (quoted as BPO) 2.5% Gel associated with Doxycycline Hyclate 100 mg Tablets compared to Adapal...
PubMed Articles
Abstract The adapalene-benzoyl peroxide (adapalene-BPO) combination gel is efficacious and safe in the treatment of acne vulgaris. We aimed in this pooled analysis to determine whether the adapalene-B...
Background: Patients with acne vulgaris often have impaired quality of life (QOL). The fixed-dose combination of benzoyl peroxide 5%/clindamycin 1% gel (BPO/C) topical gel provides an earlier onset of...
Topical dose justification: benzoyl peroxide concentrations.
Abstract Background: Benzoyl peroxide (BPO) is widely utilized in acne treatment as an alternative to antibiotics against which Propionibacterium acnes becomes more resistant. Objective: This overv...
Background: Oral antibiotics in association with a topical retinoid with or without benzoyl peroxide (BPO) are the recommended first-line option in the treatment of moderate to severe acne vulgaris...
Combination therapy addressing multiple pathogenic factors should be used to achieve optimal outcomes in treating acne. The following study demonstrated both safety and efficacy of fixed-dose clindamy...
