Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Topical Penlac Nail Lacquer for Onychomycosis in Children

This study has been completed.
Information provided by:
Rady Children's Hospital, San Diego Identifier:
First received: August 17, 2011
Last updated: NA
Last verified: May 2006
History: No changes posted

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.

Condition Intervention Phase
Drug: Ciclopirox
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Prospective, Double-blind, Placebo-controlled Trial of Topical Penlac Nail Lacquer for Therapy of Onychomycosis in Children

Resource links provided by NLM:

Further study details as provided by Rady Children's Hospital, San Diego:

Primary Outcome Measures:
  • Mycological cure or global evaluation of 2 or less Mycological Cure [ Time Frame: Week 20 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Estimated cost of therapy [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: March 2002
Study Completion Date: May 2006
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: topical Penlac nail lacquer
3-1 randomization of active to placebo
Drug: Ciclopirox
Placebo Comparator: Placebo Drug: Placebo

Detailed Description:

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


Ages Eligible for Study:   2 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01419847

United States, California
Children's Hospital-San Diego
San Diego, California, United States, 92123
Sponsors and Collaborators
Rady Children's Hospital, San Diego
Principal Investigator: Sheila F Friedlander, MD Rady Children's Hospital, San Diego
  More Information

No publications provided by Rady Children's Hospital, San Diego

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Sheila F. Frieldander, MD; PI, Rady Children's Hopsital, San Diego Identifier: NCT01419847     History of Changes
Other Study ID Numbers: 02082C (10856)
Study First Received: August 17, 2011
Last Updated: August 17, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Nail Diseases
Skin Diseases
Skin Diseases, Infectious
Anti-Infective Agents
Antifungal Agents
Pharmacologic Actions
Therapeutic Uses processed this record on November 20, 2014