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Penlac (Ciclopirox Topical) - Summary

 
 



PENLAC SUMMARY

Penlac® Nail Lacquer
(ciclopirox) Topical Solution, 8%

PENLAC® NAIL LACQUER (ciclopirox) Topical Solution, 8%, contains a synthetic antifungal agent, ciclopirox. It is intended for topical use on fingernails and toenails and immediately adjacent skin.

PENLAC® NAIL LACQUER (ciclopirox) Topical Solution, 8%, as a component of a comprehensive management program, is indicated as topical treatment in immunocompetent patients with mild to moderate onychomycosis of fingernails and toenails without lunula involvement, due to Trichophyton rubrum. The comprehensive management program includes removal of the unattached, infected nails as frequently as monthly, by a health care professional who has special competence in the diagnosis and treatment of nail disorders, including minor nail procedures.
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NEWS HIGHLIGHTS

Published Studies Related to Penlac (Ciclopirox Topical)

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.

Clinical efficacy of a new ciclopiroxolamine/zinc pyrithione shampoo in scalp seborrheic dermatitis treatment. [2006.09]
Ciclopiroxolamine (CPO) and Zinc Pirythione (ZP) antifungals are efficient at treating scalp seborrheic dermatitis.This multicentre, single-blind, clinical study was conducted to evaluate the efficacy of a shampoo containing the 1.5% CPO/1% ZP association compared to the vehicle shampoo and to 2% ketoconazole foaming gel in the treatment of seborrheic dermatitis.In 189 patients randomised to apply 1 of the 3 products twice a week for 28 days, the global lesional score, erythema, pruritus, global efficacy, quality of life (SF12 and DLQI questionnaires) and tolerance were measured at 0, 7, 14 and 28 days.The 3 products reduced lesional score, erythema and pruritus from day 7 (p < 0.0001)...

Treatment of head and neck dermatitis with ciclopiroxolamine cream--results of a double-blind, placebo-controlled study. [2006]
In atopic dermatitis, microbial allergens may be pathogenetically significant...

Ciclopirox topical solution, 8% combined with oral terbinafine to treat onychomycosis: a randomized, evaluator-blinded study. [2005.07]
This randomized, evaluator-blind, 3-arm parallel, comparator controlled, multicenter pilot study evaluated the safety and efficacy of ciclopirox nail lacquer topical solution, 8% in combination with oral terbinafine for the treatment of moderate to severe toenail onychomycosis (> or =60% disease involvement of target nail and/or lunula/matrix involvement) (N = 73)...

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Clinical Trials Related to Penlac (Ciclopirox Topical)

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.

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.

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.

Selenium Sulfide, Ketoconazole and Ciclopirox Shampoo as Additional Treatments for Tinea Capitis (Scalp Ringworm) [Recruiting]
Antifungal shampoos have been used as supplements to oral griseofulvin to help eradicate tinea capitis (also known as ringworm of the scalp) more quickly. While selenium sulfide shampoo has been the gold standard, its strong odor and its drying effect on the scalp discourage many patients from using it. Meanwhile, no other antifungal shampoo has been rigorously evaluated for efficacy. Therefore, while physicians are prescribing griseofulvin accompanied by any of a number of antifungal shampoos for tinea capitis, it is not known which antifungal shampoos (excluding selenium sulfide) actually significantly reduce time to cure, nor which do so the fastest.

Scalp ringworm can also re-occur in the same child. To date, no studies have been done to find out whether or not the use of antifungal shampoos can prevent the recurrence of scalp ringworm.

In this study, children ages 1-12 years old, who have clinically diagnosed tinea capitis, will all be prescribed oral griseofulvin for 8 weeks. In addition, they will be randomly assigned to use either selenium sulfide shampoo, ketoconazole shampoo, ciclopirox shampoo, or baby shampoo twice a week for 8 weeks. After 8 weeks, griseofulvin will be stopped. All patients will continue using the same assigned shampoo twice weekly for 24 weeks, while continuing to return to clinic every 4 weeks for scalp evaluation.

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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PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 2 ratings/reviews, Penlac has an overall score of 1. The effectiveness score is 2 and the side effect score is 10. The scores are on ten point scale: 10 - best, 1 - worst.
 

Penlac review by 51 year old female patient

  Rating
Overall rating:  
Effectiveness:   Ineffective
Side effects:   No Side Effects
  
Treatment Info
Condition / reason:   toe nail fungus
Dosage & duration:   topical solution-nail lacquer (dosage frequency: once a day) for the period of 3 months so far
Other conditions:   none
Other drugs taken:   Naftin
  
Reported Results
Benefits:   none-I'm still taking it until the bottle runs out (like 3 more months) but I'm not optimistic. My dermatologist said toe nail fungus is really hard to treat. I have it on my big toe and it's not pretty. I tried homemade remedies first-white vinegar, hydrogen peroxide and Vicks vapo rub (which didn't work either but I swear better than both of the medications) The I tried Naftin gel for 3 months and now the paint-on Penlac generic.
Side effects:   none-my frustration, lost money (the generic is $99/bottle)
Comments:   Paint the nail lacquer onto the infected nail, one coat a day, At the end of the week, remove it with alcohol and start the process all over again. Unfortunately, it seems like my nail isn't growing, which is why I'm afraid if I remove the nail (with a podiatrist) that it may not grow back-my dermatologist agrees I should not have the nail removed; she wants me to live with it. She says that even with Lamasil and all that expense and liver damaging drug, the fungus can still come back in 2 months.

 

Penlac review by 54 year old female patient

  Rating
Overall rating:  
Effectiveness:   Ineffective
Side effects:   No Side Effects
  
Treatment Info
Condition / reason:   Toenail fungus
Dosage & duration:   Topical twice a day (dosage frequency: twice a day) for the period of One month then repeated
Other conditions:   No other conditions
Other drugs taken:   None
  
Reported Results
Benefits:   None - did not work
Side effects:   No Side effects
Comments:   Topical application did not work. Tried other prescription drugs as well (topical) but did not work. Finally was advised to try a 1:5 solution of white vinegar and this cleared up the issue. The vinegar made the nail bed inhospitable to fungus and nails grew in perfect, solving this 20+ year problem that plagued me. I recommend anyone suffering from nail bed fungus to try this. I put the solution in plastic bags tied with elastic bands and walked around with them for an hour a day. Small price to pay for relief of this nasty affliction.

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Page last updated: 2011-12-09

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