Ciclopirox (Ciclopirox Olamine) - Summary

CICLOPIROX SUMMARY

CICLOPIROX TOPICAL SUSPENSION, USP
0.77% (w/w) (LOTION)

Ciclopirox Topical Suspension, USP 0.77% (Lotion) is for topical use. Each gram of Ciclopirox Topical Suspension, USP 0.77% (Lotion) contains 7.7 mg of ciclopirox (as ciclopirox olamine) in a water miscible lotion base consisting of purified water USP, cocamide DEA, octyldodecanol NF, mineral oil USP, stearyl alcohol NF, cetyl alcohol NF, polysorbate 60 NF, myristyl alcohol NF, sorbitan monostearate NF, lactic acid USP, and benzyl alcohol NF (1%) as a preservative. Ciclopirox Topical Suspension, USP 0.77% (Lotion) contains a synthetic, broad-spectrum, antifungal agent ciclopirox (as ciclopirox olamine).

Ciclopirox Topical Suspension, USP 0.77% (Lotion) is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, and Microsporum canis; cutaneous candidiasis (moniliasis) due to Candida albicans; and tinea (pityriasis) versicolor due to Malassezia furfur.

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NEWS HIGHLIGHTS

Published Studies Related to Ciclopirox

A randomized, double-blind study comparing the efficacy of selenium sulfide shampoo 1% and ciclopirox shampoo 1% as adjunctive treatments for tinea capitis in children. [2010.09]
Our objective was to compare the efficacy of selenium sulfide shampoo 1% and ciclopirox shampoo 1% as adjunctive treatments for tinea capitis in children. Forty children aged 1-11 years with clinically diagnosed tinea capitis were randomized to receive selenium sulfide shampoo 1% or ciclopirox shampoo 1% twice a week as adjuncts to an 8-week course of ultramicronized griseofulvin dosed at 10-12 mg/kg/day...

Randomized study comparing the efficacy and tolerance of a lipohydroxy acid shampoo to a ciclopiroxolamine shampoo in the treatment of scalp seborrheic dermatitis. [2009.12]
BACKGROUND: The success of a dandruff treatment depends not only on the ability of a shampoo to control dandruff, but also on patient compliance, which is closely linked to the cosmetic attributes of the product. AIM: The aim of this study was to compare efficacy, tolerance, and cosmetic properties of a LHA Shampoo [containing 0.1% lipohydroxy acid (LHA) and 1.3% salicylic acid] to a CPO shampoo [containing 1.5% ciclopiroxolamine (CPO), 3% salicylic acid, and 0.5% menthol] in subjects with seborrheic dermatitis (SD) of the scalp... CONCLUSION: In conclusion, these results demonstrated that the lipohydroxy acid shampoo evaluated in this study is a more convenient, efficient, safe, and well-tolerated cosmetic treatment for mild-to-moderate seborrheic dermatitis of the scalp than a ciclopiroxolamine shampoo.

An innovative water-soluble biopolymer improves efficacy of ciclopirox nail lacquer in the management of onychomycosis. [2009.07]
BACKGROUND: A new 8% ciclopirox-medicated nail lacquer (P-3051), based on a new technology, revealed superior properties in terms of affinity to keratin, nail permeation, and ease of use. OBJECTIVE: This study aims to assess the efficacy and safety of P-3051 vs. the market 8% ciclopirox nail lacquer... CONCLUSION: Ciclopirox 8% hydrolacquer is more active than reference ciclopirox nail lacquer in the treatment of onychomycosis.

Double-Blind Clinical Trial for Evaluating the Effectiveness and Tolerability of Ageratina pichinchensis Extract on Patients with Mild to Moderate Onychomycosis. A Comparative Study with Ciclopirox. [2008.10]
Aerial parts of AGERATINA PICHINCHENSIS have been used, in Mexican traditional medicine, as a remedy for the treatment of skin mycosis. Onychomycosis, also known as tinea of the nails or tinea unguium, constitutes an infection of the nails produced by dermatophytes.Statistical analysis demonstrated no differences between treatments.

An open randomized comparative study to test the efficacy and safety of oral terbinafine pulse as a monotherapy and in combination with topical ciclopirox olamine 8% or topical amorolfine hydrochloride 5% in the treatment of onychomycosis. [2007.11]
BACKGROUND: Onychomycosis is a fungal infection of nails caused by dermatophytes, yeasts and molds. AIMS: To study the efficacy and safety of oral terbinafine pulse as a monotherapy and in combination with topical ciclopirox olamine 8% or topical amorolfine hydrochloride 5% in onychomycosis... CONCLUSION: Terbinafine pulse therapy is effective and safe alternative in treatment of onychomycosis due to dermatophytes; and combination therapy with topical ciclopirox or amorolfine do not show any significant difference in efficacy in comparison to monotherapy with oral terbinafine.

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Clinical Trials Related to Ciclopirox

Study Evaluating the Tolerance and Biologic Activity of Oral Ciclopirox Olamine in Patients With Relapsed or Refractory Hematologic Malignancy [Recruiting]
This is an open-label, single arm study. Approximately 3-30 patients will be enrolled. Patients will receive Oral ciclopirox olamine (aqueous suspension), initial starting dose of 5 mg/m2/day administered as a single dose daily for 5 days. Three patients will initially be treated at each dose level in sequential cohorts. Dose escalation will continue for each subsequent cohort based on toxicity and plasma drug concentrations observed during the previous cohort. Dose escalation will continue until establishment of the maximum tolerated dose (MTD) has been met.

Patients who have demonstrated response to treatment, up to 6 total cycles of treatment may be administered. If additional cycles are warranted, ciclopirox olamine will be given at the same dose and frequency as the patient initially received.

Efficacy, Safety and Cost-effectiveness of a Sequential Therapy With RV4104A Ointment, Ciclopiroxolamine Cream and Ciclopirox Film-forming Solution Compared With Amorolfine Nail Lacquer in Dermatophytic Onychomycosis [Recruiting]
The purpose of the study is to evaluate and compare the efficacy of the sequential association RV4104A ointment followed by ciclopiroxolamine 1% cream and ciclopirox 8% film-forming solution versus amorolfine 5% nail lacquer alone in the treatment of patients with dermatophytic onychomycosis (toenail) without matrix involvement.

Chemoprevention of Cancer in the Lower Female Genital Tract: The Antineoplastic Activity of the Fungicide Ciclopirox. [Recruiting]
The purpose of this study is to determine if regular and daily repeated application of the ciclopirox lotion to vulva will make the precancerous lesion(s) shrink or even disappear.

Efficacy and Safety of Low-dose Oral Isotretinoin for Seborrhea [Recruiting]
Oral isotretinoin is the gold standard drug to treat moderate to severe acne. Other indications like seborrhea, seborrheic dermatitis have been suggested. There is risk of reversible mucocutaneous side effects, as well as alterations in lipid profile and transaminases. The major problem is teratogenicity which demands pregnancy control from treatment beginning to one month after treatment end. Seborrhea and seborrheic dermatitis are chronic conditions characterized by oily skin, hair and scalp, erythema, desquamation and negative impact on quality of life. This will be an interventional, therapeutic and quality of life randomized, comparative (parallel groups), blinded evaluation clinical trial, comprising 50 men and women, aged 18 to 40. Treatment with low-dose oral isotretinoin will be compared to topical anti-seborrheic products to evaluate the reduction of sebaceous secretion and colonization of affected areas by yeasts of Malassezia gender. Efficacy will be evaluated by clinical parameters, as well as by sebum secretion measure and application of quality of life questionnaires. Safety will be evaluated by skin hydration measure, side effects report and observation. For subjects using oral isotretinoin blood counting, transaminases, lipid profile and pregnancy test will be requested as selection criteria, on days 30 and 180. Data will be submitted to statistical analysis.

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