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Safety Study of Ciclopirox Olamine Cream for Dermatomycoses in Children

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ClinicalTrials.gov Identifier: NCT01646580
Recruitment Status : Terminated (Low recruitment rate. with the final sample primary endpoint could be assessed.)
First Posted : July 20, 2012
Last Update Posted : July 20, 2012
Sponsor:
Information provided by (Responsible Party):
Ferrer Internacional S.A.

Study Description
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Brief 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 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.

Condition or disease Intervention/treatment Phase
Dermatomycoses Drug: ciclopirox Phase 4

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Study for the Assessment of Safety and Efficacy of Ciclopirox Olamine Cream in 3 Months to 10 Years Old Children With Dermatomycoses
Study Start Date : October 2008
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2011

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Arms and Interventions
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Arm Intervention/treatment
Experimental: ciclopirox Drug: ciclopirox
Doses of 1.0% cream. Topical cream application. Twice daily for 28 days. Duration of treatment: 28 days with four weeks follow-up.
Other Name: Ciclochem


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Explore clinical efficacy of topically applied ciclopirox olamine cream in patients with dermatomycoses. [ Time Frame: 0, 7, 14, 21 and 28 days ]
  2. Explore mycological efficacy of topically applied ciclopirox olamine cream in patients with dermatomycoses [ Time Frame: 0, 7, 14, and 28 days ]
  3. Explore relapse rate [ Time Frame: day 56 ]

Eligibility Criteria
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Ages Eligible for Study:   3 Months to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01646580


Sponsors and Collaborators
Ferrer Internacional S.A.
Investigators
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Principal Investigator: Jose C Moreno, Prof, PhD Hospital Reina Sofia, Cordoba, Spain
More Information
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Responsible Party: Ferrer Internacional S.A.
ClinicalTrials.gov Identifier: NCT01646580    
Other Study ID Numbers: CPO_08_01
2008-003560-19 ( EudraCT Number )
First Posted: July 20, 2012    Key Record Dates
Last Update Posted: July 20, 2012
Last Verified: July 2012
Keywords provided by Ferrer Internacional S.A.:
dermatomycoses, tinea, candidiasis, children
Additional relevant MeSH terms:
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Dermatomycoses
Mycoses
Bacterial Infections and Mycoses
Infections
Skin Diseases, Infectious
 Skin Diseases
Ciclopirox
Antifungal Agents
Anti-Infective Agents