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)

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)...

Evaluation of the efficacy of ciclopirox 0.77% gel in the treatment of tinea pedis interdigitalis (dermatophytosis complex) in a randomized, double-blind, placebo-controlled trial. [2005.07]
CONCLUSION: Ciclopirox 0.77% gel, applied once or twice daily, is effective and safe in the treatment of tinea pedis interdigitalis with concomitant bacterial infection (dermatophytosis complex).

Treatment and prophylaxis of seborrheic dermatitis of the scalp with antipityrosporal 1% ciclopirox shampoo. [2005.01]
OBJECTIVE: To demonstrate the efficacy, safety, and tolerance of ciclopirox shampoo for treatment and prophylaxis of seborrheic dermatitis of the scalp... CONCLUSIONS: Seborrheic dermatitis of the scalp responds well to 1% ciclopirox shampoo once or twice weekly for 4 weeks. A low relapse rate is maintained by once-weekly shampooing or shampooing once every 2 weeks. These treatments are safe and well-tolerated.

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Clinical Trials Related to Penlac (Ciclopirox Topical)

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 Oral Isotretinoin for Cutaneous Photodamage and Seborrhea [Not yet recruiting]
This is a phase II, randomized, comparative, single evaluator-blinded trial to evaluate clinical, histological and immunohistochemical effects of oral isotretinoin plus moisturizer sunscreen as compared to the use of 0,05% tretinoin cream plus moisturizer sunscreen and anti-seborrhea products for the treatment of photodamage on face and forearms and seborrhea of face, scalp and hair. Main oral isotretinoin safety parameters will also be analyzed, as well as adverse events related to topical products.

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PATIENT REVIEWS / RATINGS / COMMENTS

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.