Topical Penlac Nail Lacquer for Onychomycosis in Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-03-31

Study Completion Date

2006-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Five months of therapy is sufficient to treat onychomycosis in children. Topical therapy of onychomycosis in children with Penlac nail lacquer has comparable efficacy and a superior cost and safety profile compared to systemic therapy.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Clinical Trial on Onychomycosis With P-3058 Nail Solution in Pediatric Population

NCT02547701

Onychomycosis

COMPLETED PHASE3

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

NCT01014637

Onychomycosis

UNKNOWN PHASE4

Safety and Pharmacokinetics of Efinaconazole Topical Solution in Subjects With Mild to Severe Onychomycosis

NCT02812771

Onychomycosis

COMPLETED PHASE4

The Efficacy of CELEXT07 in the Treatment of Toenail Onychomycosis

NCT02644551

Onychomycosis

UNKNOWN PHASE2

Study Efficacy and Safety in Comparative Use of Investigational Product Adjuvant Treatment in Onychomycosis

NCT02961634

Onychomycosis

UNKNOWN PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Therapeutic trials for the treatment of onychomycosis have been conducted in the adult population, but there is limited data available in the pediatric population.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Onychomycosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

topical Penlac nail lacquer

3-1 randomization of active to placebo

Group Type ACTIVE_COMPARATOR

Ciclopirox

Intervention Type DRUG

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ciclopirox

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Children between the ages of two and sixteen years
* Clinical diagnosis of toenail onychomycosis involving at least 20% of one nail plate
* Positive DTM reading or fungal culture for onychomycosis-either dermatophytes or non-dermatophyte mold
* Consent to participate in the study
* Women of child-bearing potential must have a negative urine pregnancy test at the baseline visit and be willing to practice effective contraception for the duration of the study.

Exclusion Criteria

* Children with allergy to Penlac or one of its ingredients
* Structural deformity of target nail plate
* Presence of active psoriasis or severe foot eczema
* Presence of immunodeficiency disorder
* Concurrent immune suppressive therapy or immune suppressive therapy within the last 3 months
* Previous systemic antifungal therapy within the last 6 months
* Previous topical antifungal therapy within the last 14 days
* Female subjects who are pregnant, nursing mothers, those planning a pregnancy during the course of the study, or who become pregnant

Minimum Eligible Age

2 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No