DermatomycosesPhase 4NCT01646580
Safety Study of Ciclopirox Olamine Cream for Dermatomycoses in Children
A Phase 4 study testing ciclopirox in people with Dermatomycoses, run by Ferrer Internacional S.A..
Trial summary
Ciclopirox olamine (Ciclochem®) is a pyridone broad spectrum antifungal drug which has shown activity on dermatophytes, yeasts, moulds, actinomycetes and some bacteria. Its mechanism of action is based on a fungicidal activity by inhibiting the cellular captation of essential substances needed for the metabolism and… Read more about this study
- Who is it for?
- Ages 3 months to 10 years
- Conditions the study is for
- Dermatomycoses
- What is being tested?
- ciclopirox
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- No sites listed yet
- Study dates
- Oct 2008to Nov 2011
- 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 3 months to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients from 3 months to 10 years of age.
- Patients diagnosed of dermatomycoses produced by yeasts or dermatophytes by KOH technique at the inclusion moment, which has to be confirmed by culture.
- Obtention of the informed consent of the parents or legal representatives of the patients
Who cannot join
- Previous treatment with oral or topical antifungal drugs.
- Hypersensitivity to ciclopirox olamine or some of the cream excipients.
- Use of topical or oral steroids concomitantly.
- Patients with mycoses on the scalp or nails.
About this study
Official title: Study for the Assessment of Safety and Efficacy of Ciclopirox Olamine Cream in 3 Months to 10 Years Old Children With Dermatomycoses
Ciclopirox olamine (Ciclochem®) is a pyridone broad spectrum antifungal drug which has shown activity on dermatophytes, yeasts, moulds, actinomycetes and some bacteria. Its mechanism of action is based on a fungicidal activity by inhibiting the cellular captation of essential substances needed for the metabolism and growth of the fungi. On the other hand, this drug binds irreversibly with cell structures as mitochondria, ribosomes, microsomes and cell wall. After dermal application, Ciclopirox olamine undergoes skin penetration, being only absorbed a 1,5% of the applied dose. Clinical efficacy has been studied in patients above 10 years with superficial dermatomycoses (dermatophytoses, candidiasis and pityriasis versicolor) and the percentage of clinical healing ranged from 77% to 91% after 2-4 weeks of twice a day topical application. In all the studies, the safety profile has been very good, showing only a very low rate of adverse events of mild to moderate intensity. There are very few previous available data on the application of this compound in children under 10 years of age. A single study had been performed with a solution formulation in patients from 6 to 29 months with diaper candidiasis, showing good efficacy and tolerability in these patients. The present study aims to show the safety and tolerability of ciclopirox olamine in a cream formulation in patients from 3 months to 10 years with dermatomycoses.
Read the detailed description
A multicenter, open, prospective, Phase IV study of Ciclopirox olamine on patients from 3 months to 10 years with all kinds of dermatomycoses. All body areas were treatable except scalp and nails (no tinea on the scalp nor onychomycoses) . Cream applied BID between 6.00 and 10.00am and 7.00 and 10.00pm daily for 4 weeks.Control visit after 4 more weeks without treatment was performed in order to evaluate the relapse rate.
- Conditions
- Dermatomycoses
- Being tested
- ciclopirox
- Keywords
- dermatomycoses, tinea, candidiasis, children
- Medical subject headings
- Dermatomycoses, Tinea, Candidiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ciclopiroxDrug
Also called Ciclochem
Doses of 1.0% cream. Topical cream application. Twice daily for 28 days. Duration of treatment: 28 days with four weeks follow-up.
| Study group | Role | What they receive |
|---|---|---|
| ciclopirox | Experimental | Not described Receives: Drug: ciclopirox |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate skin lesion condition as a measure of safety and tolerability of ciclopirox olamine treated dermatomycoses patients from 3 months to 10 years.
Measured: 28 days
Secondary outcomes (3)
Explore clinical efficacy of topically applied ciclopirox olamine cream in patients with dermatomycoses.
Measured: 0, 7, 14, 21 and 28 days
Explore mycological efficacy of topically applied ciclopirox olamine cream in patients with dermatomycoses
Measured: 0, 7, 14, and 28 days
Explore relapse rate
Measured: day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2012 (estimated)
- Study startOct 2008
- Primary completionNov 2011
- Study completionNov 2011
Why it stopped: Low recruitment rate. with the final sample primary endpoint could be assessed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DermatomycosesStudies 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ferrer Internacional S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jose C Moreno, Prof, PhD, Principal investigator, Hospital Reina Sofia, Cordoba, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01646580
- Sponsor's protocol ID
- CPO_08_01
- Other IDs
- 2008-003560-19, 2008
- Status last verified
- Jul 2012
- First submitted
- 12 Jul 2012
- Last updated
- 20 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study for the Assessment of Safety and Efficacy of Ciclopirox Olamine Cream in 3 Months to 10 Years Old Children With Dermatomycoses
- ClinicalTrials.gov ID
- NCT01646580
- Acronym / sponsor ID
- CPO_08_01
- Conditions
- Dermatomycoses
- Keywords
- dermatomycoses, tinea, candidiasis, children
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low recruitment rate. with the final sample primary endpoint could be assessed.
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Ferrer Internacional S.A.Industry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 20 Jul 2012 (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.
Ciclopirox olamine (Ciclochem®) is a pyridone broad spectrum antifungal drug which has shown activity on dermatophytes, yeasts, moulds, actinomycetes and some bacteria. Its mechanism of action is based on a fungicidal activity by inhibiting the cellular captation of essential substances needed for the metabolism and growth of the fungi. On the other hand, this drug binds irreversibly with cell structures as mitochondria, ribosomes, microsomes and cell wall. After dermal application, Ciclopirox olamine undergoes skin penetration, being only absorbed a 1,5% of the applied dose. Clinical efficacy has been studied in patients above 10 years with superficial dermatomycoses (dermatophytoses, candidiasis and pityriasis versicolor) and the percentage of clinical healing ranged from 77% to 91% after 2-4 weeks of twice a day topical application. In all the studies, the safety profile has been very good, showing only a very low rate of adverse events of mild to moderate intensity. There are very few previous available data on the application of this compound in children under 10 years of age. A single study had been performed with a solution formulation in patients from 6 to 29 months with diaper candidiasis, showing good efficacy and tolerability in these patients. The present study aims to show the safety and tolerability of ciclopirox olamine in a cream formulation in patients from 3 months to 10 years with dermatomycoses.
Detailed description
A multicenter, open, prospective, Phase IV study of Ciclopirox olamine on patients from 3 months to 10 years with all kinds of dermatomycoses. All body areas were treatable except scalp and nails (no tinea on the scalp nor onychomycoses) . Cream applied BID between 6.00 and 10.00am and 7.00 and 10.00pm daily for 4 weeks.Control visit after 4 more weeks without treatment was performed in order to evaluate the relapse rate.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ciclopirox | Experimental | Drug: ciclopirox |
Who may qualify
- Ages
- 3 months to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Patients from 3 months to 10 years of age.
- Patients diagnosed of dermatomycoses produced by yeasts or dermatophytes by KOH technique at the inclusion moment, which has to be confirmed by culture.
- Obtention of the informed consent of the parents or legal representatives of the patients
Key exclusion criteria (4 listed)
- Previous treatment with oral or topical antifungal drugs.
- Hypersensitivity to ciclopirox olamine or some of the cream excipients.
- Use of topical or oral steroids concomitantly.
- Patients with mycoses on the scalp or nails.
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 |
|---|---|---|
| ciclopiroxAlso: CiclochemDoses of 1.0% cream. Topical cream application. Twice daily for 28 days. Duration of treatment: 28 days with four weeks follow-up. | Drug | ciclopirox |
Primary outcome
To evaluate skin lesion condition as a measure of safety and tolerability of ciclopirox olamine treated dermatomycoses patients from 3 months to 10 years.
Time frame: 28 days
3 secondary outcomes
Explore clinical efficacy of topically applied ciclopirox olamine cream in patients with dermatomycoses.
Time frame: 0, 7, 14, 21 and 28 days
Explore mycological efficacy of topically applied ciclopirox olamine cream in patients with dermatomycoses
Time frame: 0, 7, 14, and 28 days
Explore relapse rate
Time frame: day 56
Results and safety
The study was stopped early (reason given: Low recruitment rate. with the final sample primary endpoint could be assessed.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2012.
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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.
Jose C Moreno, Prof, PhD principal investigator
Hospital Reina Sofia, Cordoba, Spain
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ciclopirox in people with Dermatomycoses, run by Ferrer Internacional S.A..
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 3 inclusion and 4 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: stopped early, as of the sponsor's last update on 20 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 was stopped early (reason given: Low recruitment rate. with the final sample primary endpoint could be assessed.). Results are not available in the source record.
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?
To evaluate skin lesion condition as a measure of safety and tolerability of ciclopirox olamine treated dermatomycoses patients from 3 months to 10 years. (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jul 2012.