OnychomycosisPhase 4NCT01419847
Topical Penlac Nail Lacquer for Onychomycosis in Children
A Phase 4 study testing Ciclopirox in people with Onychomycosis, run by Rady Children's Hospital, San Diego at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 2 to 16 years
- Conditions the study is for
- Onychomycosis
- What is being tested?
- Ciclopirox
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2002to May 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital-San Diego
San Diego, California, 92123
About this study
Official title: A Prospective, Double-blind, Placebo-controlled Trial of Topical Penlac Nail Lacquer for Therapy of Onychomycosis in Children
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.
Read the 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.
- Conditions
- Onychomycosis
- Being tested
- Ciclopirox, Placebo
- Medical subject headings
- Onychomycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CiclopiroxDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| topical Penlac nail lacquer | Active comparator | 3-1 randomization of active to placebo Receives: Drug: Ciclopirox |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mycological cure or global evaluation of 2 or less Mycological Cure
Measured: Week 20
Secondary outcomes (1)
Estimated cost of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2011 (estimated)
- Study startMar 2002
- Primary completionDec 2005
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OnychomycosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rady Children's Hospital, San Diego
- Sponsor type
- University, hospital or other
- Investigators
- Sheila F Friedlander, MD, Principal investigator, Rady Children's Hospital, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01419847
- Sponsor's protocol ID
- 02082C (10856)
- Status last verified
- May 2006
- First submitted
- 17 Aug 2011
- Last updated
- 18 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Friedlander SF, Chan YC, Chan YH, Eichenfield LF. Onychomycosis does not always require systemic treatment for cure: a trial using topical therapy. Pediatr Dermatol. 2013 May-Jun;30(3):316-22. doi: 10.1111/pde.12064. Epub 2012 Dec 28.
PubMed 23278851
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Double-blind, Placebo-controlled Trial of Topical Penlac Nail Lacquer for Therapy of Onychomycosis in Children
- ClinicalTrials.gov ID
- NCT01419847
- Acronym / sponsor ID
- 02082C (10856)
- Conditions
- Onychomycosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Rady Children's Hospital, San DiegoUniversity, hospital or other
- Study start
- Mar 2002
- Primary completion
- Dec 2005 (actual)
- Study completion
- May 2006 (actual)
- First posted
- 18 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| topical Penlac nail lacquer | Active comparator | Drug: Ciclopirox3-1 randomization of active to placebo |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 2 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ciclopirox | Drug | topical Penlac nail lacquer |
| Placebo | Drug | Placebo |
Primary outcome
Mycological cure or global evaluation of 2 or less Mycological Cure
Time frame: Week 20
1 secondary outcome
Estimated cost of therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2011.
- Derived from this study: PubMed 23278851Friedlander SF, Chan YC, Chan YH, Eichenfield LF. Onychomycosis does not always require systemic treatment for cure: a trial using topical therapy. Pediatr Dermatol. 2013 May-Jun;30(3):316-22. doi: 10.1111/pde.12064. Epub 2012 Dec 28.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sheila F Friedlander, MD principal investigator
Rady Children's Hospital, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ciclopirox in people with Onychomycosis, run by Rady Children's Hospital, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mycological cure or global evaluation of 2 or less Mycological Cure (time frame: Week 20). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01419847, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2011.