Biomaterial Database

A double-blind clinical trial with a lotion containing 5% benzoyl peroxide and 2% miconazole in patients with acne vulgaris. 1989

J Mesquita-Guimarães, and S Ramos, and M R Tavares, and M R Carvalho

The therapeutic efficacy of a lotion containing 5% benzoyl peroxide and 2% miconazole was compared with 5% benzoyl peroxide alone, in a double-blind, randomized, parallel study. Thirty patients with comedonal or inflammatory acne vulgaris were enrolled. The medications were applied once daily during the first week, and then twice daily for the rest of the trial (45 days). In patients with comedonal acne there was no difference in the effect of the two therapies. In patients with inflammatory acne the percentage reduction of the number of lesions on Day 30 was significantly higher in the benzoyl peroxide plus miconazole group (66%) compared to benzoyl peroxide alone (37%). At Day 45 there was a trend favouring the combined therapy but the difference was not significant. There were no significant differences in the adverse reactions reported by the two groups of patients (erythema, itching or moderate exfoliation).

UI	MeSH Term	Description	Entries
D008297	Male		Males
D008825	Miconazole	An imidazole antifungal agent that is used topically and by intravenous infusion.	Brentan,Dactarin,Miconasil Nitrate,Miconazole Nitrate,Monistat,R-14,889,Nitrate, Miconasil,Nitrate, Miconazole,R 14,889,R14,889
D010545	Peroxides	A group of compounds that contain a bivalent O-O group, i.e., the oxygen atoms are univalent. They can either be inorganic or organic in nature. Such compounds release atomic (nascent) oxygen readily. Thus they are strong oxidizing agents and fire hazards when in contact with combustible materials, especially under high-temperature conditions. The chief industrial uses of peroxides are as oxidizing agents, bleaching agents, and initiators of polymerization. (From Hawley's Condensed Chemical Dictionary, 11th ed)	Peroxide
D011897	Random Allocation	A process involving chance used in therapeutic trials or other research endeavor for allocating experimental subjects, human or animal, between treatment and control groups, or among treatment groups. It may also apply to experiments on inanimate objects.	Randomization,Allocation, Random
D002986	Clinical Trials as Topic	Works about pre-planned studies of the safety, efficacy, or optimum dosage schedule (if appropriate) of one or more diagnostic, therapeutic, or prophylactic drugs, devices, or techniques selected according to predetermined criteria of eligibility and observed for predefined evidence of favorable and unfavorable effects. This concept includes clinical trials conducted both in the U.S. and in other countries.	Clinical Trial as Topic
D004311	Double-Blind Method	A method of studying a drug or procedure in which both the subjects and investigators are kept unaware of who is actually getting which specific treatment.	Double-Masked Study,Double-Blind Study,Double-Masked Method,Double Blind Method,Double Blind Study,Double Masked Method,Double Masked Study,Double-Blind Methods,Double-Blind Studies,Double-Masked Methods,Double-Masked Studies,Method, Double-Blind,Method, Double-Masked,Methods, Double-Blind,Methods, Double-Masked,Studies, Double-Blind,Studies, Double-Masked,Study, Double-Blind,Study, Double-Masked
D004338	Drug Combinations	Single preparations containing two or more active agents, for the purpose of their concurrent administration as a fixed dose mixture.	Drug Combination,Combination, Drug,Combinations, Drug
D005260	Female		Females
D006801	Humans	Members of the species Homo sapiens.	Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000152	Acne Vulgaris	A chronic disorder of the pilosebaceous apparatus associated with an increase in sebum secretion. It is characterized by open comedones (blackheads), closed comedones (whiteheads), and pustular nodules. The cause is unknown, but heredity and age are predisposing factors.	Acne