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Loprox Shampoo

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Loprox Shampoo

CLINICAL PHARMACOLOGY

Mechanism of Action

Ciclopirox is a hydroxypyridone antifungal agent although the relevance of this property for the indication of seborrheic dermatitis is not known. Ciclopirox acts by chelation of polyvalent cations (Fe3+ or Al3+), resulting in the inhibition of the metal-dependent enzymes that are responsible for the degradation of peroxides within the fungal cell.

Pharmacokinetics and Pharmacodynamics

In a study in patients with seborrheic dermatitis of the scalp, application of 5 mL ciclopirox shampoo 1% twice weekly for 4 weeks, with an exposure time of 3 minutes per application, resulted in detectable serum concentrations of ciclopirox in 6 out of 18 patients. The serum concentrations measured throughout the dosing interval on Days 1 and 29 ranged from 10.3 ng/mL to 13.2 ng/mL. Total urinary excretion of ciclopirox was less than 0.5% of the administered dose.

Clinical Studies

In two randomized, double-blind clinical trials, patients 16 years and older with seborrheic dermatitis of the scalp applied LOPROX Shampoo (ciclopirox shampoo) or its vehicle two times per week for 4 weeks. Patients who were immunocompromised, those with psoriasis or atopic dermatitis, women of childbearing potential not using adequate contraception, and pregnant or lactating women were excluded from the clinical studies. An evaluation of the overall status of the seborrheic dermatitis, and the presence and severity of erythema or inflammation, and scaling, was made at week 4, using a scale of 0 = none, 1 = slight, 2 = mild, 3 = moderate, 4 = pronounced, and 5 = severe. Effective treatment was defined as achieving a score of 0 (or a score of 1 if the baseline score was ≥ 3) simultaneously for status of the seborrheic dermatitis, erythema or inflammation, and scaling at Week 4. Ciclopirox shampoo was shown to be statistically significantly more effective than vehicle in both studies. Efficacy results for the two studies are presented in the following table.

Effective Treatment Rates at Week 4 in Studies 1 and 2

  Ciclopirox Shampoo Vehicle
Study 1 220/380 (58%) 60/192 (31%)
Study 2 65/250 (26%) 32/249 (13%)

Efficacy for black patients was not demonstrated, although only 53 black patients were enrolled in the two pivotal studies.

Microbiology

Ciclopirox is fungicidal in vitro against Malassezia furfur (Pityrosporum spp.), P. ovale, and P. orbiculare. Ciclopirox acts by chelation of polyvalent cations (Fe3+ or Al3+), resulting in the inhibition of the metal-dependent enzymes that are responsible for the degradation of peroxides within the fungal cell.

The clinical significance of antifungal activity in the treatment of seborrheic dermatitis is not known.

Last reviewed on RxList: 11/5/2008
This monograph has been modified to include the generic and brand name in many instances.

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