Efficacy and safety of terbinafine for nondermatophyte and mixed nondermatophyte and dermatophyte toenail onychomycosis.
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Adolescent↗
Biomedical subjects
J Leyden
Publications and source records attributed to J Leyden.
The combination formulation of clindamycin 1% plus benzoyl peroxide 5% versus 3 different formulations of topical clindamycin alone in the reduction of Propionibacterium acnes. An in vivo comparative study.
BACKGROUND: Isolates of Propionibacterium acnes resistant to one or more anti-acne antibiotics (most commonly erythromycin) are being increasingly reported, and the emergence of resistant strains can be associated with therapeutic failure of topical treatment. OBJECTIVE: Comparison of the in vivo effectiveness of the combination of clindamycin 1% plus benzoyl peroxide 5% in a gel formulation to that of each of 3 clindamycin 1% preparations (gel, lotion, and solution) with respect to reduction in counts of P. acnes cultured from the foreheads of healthy volunteers. METHODS: The effects of treatment with the 4 study drugs were compared in an open-label study. Cultures were collected before, after 1 week and after 2 weeks of treatment. RESULTS: Treatment with the combination formulation resulted in a 99.8% (> 2 logs) reduction in total propionibacterial numbers after 1 week of therapy compared with 30 to 62% (< 1 log) decreases for the different formulations of topical clindamycin alone. By the end of week 2, the combination had decreased P. acnes counts by more than 99.9% (> 3 logs) relative to reductions of from 88 to 95% (< or > 1 log) for the single agent formulations. CONCLUSIONS: Under the conditions of the present study, the combination of clindamycin 1% plus benzoyl peroxide 5% gel produced more rapid and highly significant reductions in P. acnes compared with formulations containing clindamycin alone.
Adolescent↗
Therapeutic studies with a new combination benzoyl peroxide/clindamycin topical gel in acne vulgaris.
Three independent clinical studies were conducted in more than 1250 patients with moderate to moderately severe acne vulgaris to evaluate the efficacy and safety of a new combination gel that stably combines 5% benzoyl peroxide and 1% clindamycin. The results indicated that the benzoyl peroxide/clindamycin combination product was an effective treatment for reducing the inflammatory and noninflammatory lesions of acne vulgaris. In overall improvement as rated by the physicians and patients, the combination gel was superior to clindamycin alone, and in 2 of the 3 studies, to benzoyl peroxide alone. The antimicrobial activity of the combination gel was significantly (each P < .01) superior to that seen with topical application of its individual constituents, 5% benzoyl peroxide or 1% clindamycin, and was numerically better than that found with topical application of a 5% benzoyl peroxide/3% erythromycin combination product. As with benzoyl peroxide, dry skin was the most frequent side effect with use of the combination gel, with isolated incidences of other localized irritation. No other safety or tolerability concerns were identified.
Acne Vulgaris↗
The development of antibiotic resistance in Propionibacterium acnes.
Two separate studies evaluated the ability of a combination topical gel consisting of 5% benzoyl peroxide and 1% clindamycin to reduce facial Propionibacterium acnes counts in vivo and to decrease the development of resistant organisms. In the first study, the combination gel was compared with 3 topical formulations of 1% clindamycin phosphate (gel, lotion, and solution) in 80 individuals. After only 1 week of treatment, a 99.7% reduction from baseline in facial P acnes count was obtained with the combination gel. This was significantly greater (P < .001) than the 30%, 56%, or 62% reduction obtained with the clindamycin gel, lotion, or solution, respectively. After 2 weeks of treatment, the reduction from baseline P acnes counts with the combination gel was increased to 99.9%, which was again significantly greater (P < .001) than that with 1% clindamycin alone, regardless of the formulation. The second study compared the combination gel with 1% clindamycin gel in 79 patients with mild to moderate acne. After 4 weeks of treatment, the combination gel was more effective than clindamycin alone in reducing the total P acnes count, consistent with the previous study. By week 12, an increase in the number of resistant bacteria appeared in samples from patients using clindamycin alone, while counts of resistant bacteria remained stable or declined in those using the combination gel.
Benzoyl Peroxide↗
Are 2 combined antimicrobial mechanisms better than 1 for the treatment of acne vulgaris? Clinical and antimicrobial results of a topical combination product containing 1% clindamycin and 5% benzoyl peroxide. Introduction.
Acne vulgaris is the most common chronic skin condition seen by dermatologists. Available topical therapies include comedolytic agents such as tretinoin, adapalene, azelaic acid, tazarotene, and salicylic acid; bactericidal agents such as benzoyl peroxide; antibiotics such as clindamycin, erythromycin, and tetracycline; and anti-inflammatory agents such as sodium sulfacetamide and metronidazole. Therapeutic failure with some antibiotic regimens due to the presence or development of resistant strains is becoming an increasing problem in the treatment of acne. One strategy aimed at limiting the resistant Propionibacterium acnes population is the use of treatment regimens that incorporate agents with complementary but different mechanisms of action. A combination gel consisting of 5% benzoyl peroxide and 1% clindamycin has recently become available. This supplement summarizes the dermatopharmacology, clinical efficacy, and tolerability of this combination gel, along with its potential role in the management of acne vulgaris.
Acne Vulgaris↗
Comparison of treatment of acne vulgaris with alternate-day applications of tazarotene 0.1% gel and once-daily applications of adapalene 0.1% gel: a randomized trial.
Tazarotene and adapalene are recently introduced topical retinoids that are useful in the treatment of acne vulgaris. The clinical benefits of each drug have now been compared in a multicenter, double-blind, randomized, parallel-group study involving 164 patients with mild-to-moderate facial acne vulgaris. Patients were randomized to receive 15 weeks' treatment with alternate-day tazarotene 0.1% gel, with vehicle gel on the intervening evenings, or once-daily adapalene 0.1% gel. Both regimens were comparably effective with no significant between-group differences in efficacy measures. A total of 74% of tazarotene-treated subjects and 73% of adapalene-treated subjects achieved at least a 50% improvement in their acne. In addition, there were no clinically significant differences in tolerability. It is concluded that an alternate-day tazarotene regimen offers efficacy and thus tazarotene treatment can be useful even in patients whose compliance may be suboptimal. An alternate-day regimen also offers the potential for considerable savings in drug costs.
Acne Vulgaris↗
Randomized facial tolerability studies comparing gel formulations of retinoids used to treat acne vulgaris.
Two double-blind, randomized, split-face studies have been performed to compare the facial tolerability of topical retinoids in volunteers with sensitive skin. In one study, subjects applied tazarotene 0.1% gel to one side of their face and tretinoin 0.1% gel microsponge, tretinoin 0.025% gel, or adapalene 0.1% gel to the other side of their face, for up to 29 days. Increases in facial dryness and erythema were comparable among all retinoids. Some subjects in each treatment group experienced levels of retinoid-associated irritation that required temporary suspension of, or reduction in, treatment. Facial dryness and erythema tended to be greater in these subjects than in those who tolerated the regimen without change, suggesting that the need to discontinue or modify treatment depends more on the individual than on any major inherent differences in the irritant potential of these retinoids. A second study compared once-daily versus alternate-day tazarotene 0.1% gel therapy. Tolerability was superior when initiating therapy with the alternate-day regimen.
Acne Vulgaris↗
Adapalene in clinical practice.
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Acne Vulgaris↗
In situ measurements of labile Cu, Cd and Mn in river waters using DGT.
The technique of diffusive gradients in thin-films (DGT) has been trialed in two river systems for in situ trace metal speciation measurements. This paper presents results for cadmium, copper and manganese concentrations in fresh and estuarine waters and demonstrates for the first time the effectiveness of using DGT to measure labile metal concentrations in such waters. This work has shown that even with very simple deployment systems the technique is sensitive and reproducible. The precision of in situ DGT measurements was typically 11% or better when the precision of subsequent analysis was good. The in-built metal pre-concentration procedure of DGT allowed Cd to be measured at concentrations below the detection limit of a direct determination by GF-AAS. The theoretically predicted linear increase in mass with time was obtained in river deployments of up to 72 h, confirming steady state river conditions and indicating no adverse effects due to biofouling over this period. Concentrations of DGT-labile Cu and Cd were equal to dissolved (0.45 micron) metal concentrations for the Ring and Stitt Rivers indicating the absence of tightly bound organic complexes or colloidal species. DGT-labile Cu and Cd were approximately 50% of the dissolved metal in the Que River and DGT-labile Cu was approximately 30% of dissolved Cu in the Savage River. A concentration-depth profile of labile manganese was obtained in a stratified estuary by deployment of a string of DGT devices at 0.3-m intervals across the redoxcline. Results revealed a large spike (maximum concentration = 1.4 mg/l) of DGT-labile Mn at the base of the redoxcline and demonstrate the utility of DGT to determine vertical changes in metal speciation across redox boundaries in stratified estuarine systems. It is in such dynamic systems as this that the in situ capabilities of DGT are likely to be most useful. DGT records multiple metal species as they exist in situ, overcoming the considerable problems of contamination often associated with sample collection and handling.
Australia↗
Finasteride in the treatment of men with frontal male pattern hair loss.
BACKGROUND: Finasteride, a specific inhibitor of type II 5alpha-reductase, decreases serum and scalp dihydrotestosterone and has been shown to be effective in men with vertex male pattern hair loss. OBJECTIVE: This study evaluated the efficacy of finasteride 1 mg/day in men with frontal (anterior/mid) scalp hair thinning. METHODS: This was a 1-year, double-blind, placebo-controlled study followed by a 1-year open extension. Efficacy was assessed by hair counts (1 cm2 circular area), patient and investigator assessments, and global photographic review. RESULTS: There was a significant increase in hair count in the frontal scalp of finasteride-treated patients (P < .001), as well as significant improvements in patient, investigator, and global photographic assessments. Efficacy was maintained or improved throughout the second year of the study. Finasteride was generally well tolerated. CONCLUSION: In men with hair loss in the anterior/mid area of the scalp, finasteride 1 mg/day slowed hair loss and increased hair growth.
5-alpha Reductase Inhibitors↗
Topical retinoids in the treatment of acne vulgaris.
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Acne Vulgaris↗
Pharmacokinetics and pharmacology of terbinafine and itraconazole.
BACKGROUND: Two new systemic antifungal agents, terbinafine and itraconazole, have expanded the choices for treatment of onychomycosis. The pharmacokinetic and pharmacologic properties provide the basis of their activity and are related to their efficacy and safety in dermatophyte infections. OBJECTIVE: We describe the pharmacodynamics, pharmacokinetics, and pharmacology of terbinafine and itraconazole and the features that form a framework for comparing their efficacy. PHARMACODYNAMICS: Both terbinafine and itraconazole ultimately block ergosterol synthesis; terbinafine disrupts fungal cell wall synthesis earlier (squalene to squalene epoxide) than does itraconazole (lanosterol to ergosterol). In vitro, terbinafine exposure results in a toxic accumulation of squalene and decreased production of ergosterol. Minimal inhibitory concentrations (MICs) of terbinafine for dermatophytes are essentially equal to minimal fungicidal concentrations (MFCs). However, the MFCs of itraconazole are much higher than the MICs. PHARMACOLOGIC PROFILE: Both itraconazole and terbinafine penetrate keratinizing tissue; levels reached in nail plate exceed those in plasma. Therapeutic levels of the itraconazole persist in nails for up to 6 months after discontinuation of 3 months of therapy (200 mg/day) and during various pulsed cycles. After discontinuation of 1 month of therapy, terbinafine persists at therapeutic levels in the nail. Itraconazole has an affinity for mammalian cytochrome P-450 enzymes as well as for fungal P-450-dependent enzyme, and thus has the potential for clinically important interactions (e.g., astemizole, terfenadine, rifampin, oral contraceptives, H2 receptor antagonists, warfarin, cyclosporine). Terbinafine is not metabolized through this system and has little potential for drug-drug interactions. CONCLUSION: The low MFCs exhibited by terbinafine for dermatophytes may be important in its clinical efficacy and low relapse rates. The safety profile of terbinafine directly reflects its mechanism of action.
Antifungal Agents↗
Palmoplantar keratoderma associated with hypothyroidism.
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Aged↗
Efficacy of terbinafine 1% cream in the treatment of moccasin-type tinea pedis: results of placebo-controlled multicenter trials.
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Administration, Cutaneous↗
Efficacy of a 1-week, twice-daily regimen of terbinafine 1% cream in the treatment of interdigital tinea pedis. Results of placebo-controlled, double-blind, multicenter trials.
BACKGROUND: Patients with tinea pedis often discontinue treatment before eradication of the fungus when their symptoms improve. The result is an incomplete cure/recurrence. OBJECTIVE: Terbinafine, a topical fungicidal agent, was evaluated in double-blind, placebo-controlled trials (159 patients) for its ability to achieve cure and relief of symptoms in the same time frame, that is, before compliance wanes. METHODS: Mycologic characteristics (with potassium hydroxide examination and culture) and clinical signs and symptoms were assessed at baseline, at the end of a 1-week, twice-daily treatment and at 1, 3, and 5 weeks after the completion of therapy. RESULTS: Both terbinafine and vehicle provided early relief of symptoms. However, only terbinafine gave progressive mycologic improvement such that at 5 weeks after treatment, 88% of the patients receiving terbinafine had converted from positive to negative mycology compared with 23% of the patients treated with vehicle. CONCLUSION: The rapid and potent fungicidal action of terbinafine results in a high cure rate in interdigital tinea pedis with 1 week of treatment and may avoid failures caused by non-compliance.
Antifungal Agents↗
Controlled release of benzoyl peroxide from a porous microsphere polymeric system can reduce topical irritancy.
Skin absorption of benzoyl peroxide from a topical lotion containing freely dispersed drug was compared with that from the same lotion in which the drug was entrapped in a controlled-release styrene-divinylbenzene polymer system. In an in vitro diffusion system, statistically significant (p = 0.01) differences were found in the content of benzoyl peroxide in excised human skin and in percutaneous absorption. In vivo, significantly (p = 0.002) less benzoyl peroxide was absorbed through rhesus monkey skin from the polymeric system. This controlled release of benzoyl peroxide to skin can alter the dose relation that exists between efficacy and skin irritation. Corresponding studies showed reduced skin irritation in cumulative irritancy studies in rabbits and human beings, whereas in vivo human antimicrobial efficacy studies showed that application of the formulations containing entrapped benzoyl peroxide significantly reduced counts of Propionibacterium acnes (p less than 0.001) and aerobic bacteria (p less than 0.001) and the free fatty acid/triglyceride ratio in skin lipids. These findings support the hypothesis that, at least for this drug, controlled topical delivery can enhance safety without sacrificing efficacy.
Administration, Cutaneous↗