Clinical Study Between Two Clindamycin 1%/Benzoyl Peroxide 5% Topical Gels
Summary
The purpose of this study is to compare the efficacy and safety profiles of Perrigo Israel Pharmaceuticals, Ltd. Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel and Benzaclin® Topical Gel (Clindamycin- Benzoyl Peroxide Gel).
Study Design
Primary Purpose: Treatment
Conditions
Acne Vulgaris
Intervention
Clindamycin 1% / Benzoyl Peroxide 5% (Perrigo), Clindamycin 1% / Benzoyl Peroxide 5% (Benzaclin), Placebo
Status
Active, not recruiting
Source
Perrigo Company
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01138514
- 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.
Clindamycin
An antibacterial agent that is a semisynthetic analog of LINCOMYCIN.
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 single-blind (blinded expert grader) study that will enroll 25-30 healthy volunteers without facial acne. On 1 side of the face, the subject will apply 1 of the 2 test products,...
A Pilot, Multi-Center, Patient Preference Study Comparing Two Clindamycin/Benzoyl Peroxide Gels.
Evaluate patient preference factors comparing two clindamycin/benzoyl peroxide gels. One dispensed in a pump presentation, the other in a tube presentation.
A Study to Evaluate Tolerability of Two Topical Drug Products in the Treatment of Facial Acne
Multi-center, single-blind, randomized, comparative, split-face study. The duration of the study is 8 weeks. Commencing at baseline, subjects will apply once daily both clindamycin and be...
Trial of Clindamycin / Benzoyl Peroxide Gel in Subjects With Acne
This is a Randomized, Double-Blind, Controlled Study to evaluate the Safety and Efficacy of a clindamycin / benzoyl peroxide gel in Subjects with Acne Vulgaris
Clinical Study Between Two 1% Clindamycin/5% Benzoyl Peroxide Topical Gel Formulations
A randomized, double-blind, multiple-site, placebo-controlled, parallel-group clinical study conducted to evaluate the bioequivalence of two 1% Clindamycin/5% Benzoyl Peroxide Topical Gel...
PubMed Articles
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...
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...
Clindamycin phosphate (CDP), benzoyl peroxide (BPO) and salicylic acid (SA) are known to be effective acne therapy agents depending on their anti-inflammatory and comedolytic properties. The purpose o...
Newer Approaches to the Treatment of Acne Vulgaris.
The multifactorial etiology of acne vulgaris makes it challenging to treat. Current treatments include topical retinoids, benzoyl peroxide, topical and systemic antibiotics, azelaic acid, and systemic...
