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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01419847
Other study ID # 02082C (10856)
Secondary ID
Status Completed
Phase Phase 4
First received August 17, 2011
Last updated August 17, 2011
Start date March 2002
Est. completion date May 2006

Study information

Verified date May 2006
Source Rady Children's Hospital, San Diego
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date May 2006
Est. primary completion date December 2005
Accepts healthy volunteers No
Gender Both
Age group 2 Years to 16 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Ciclopirox

Placebo


Locations

Country Name City State
United States Children's Hospital-San Diego San Diego California

Sponsors (1)

Lead Sponsor Collaborator
Rady Children's Hospital, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mycological cure or global evaluation of 2 or less Mycological Cure Week 20 No
Secondary Estimated cost of therapy No
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