Safety Study of Ciclopirox Olamine Cream for Dermatomycoses in Children (No)

This study has been terminated.
(Low recruitment rate. with the final sample primary endpoint could be assessed.)
Sponsor:
Information provided by (Responsible Party):
Ferrer Internacional S.A.
ClinicalTrials.gov Identifier:
NCT01646580
First received: July 12, 2012
Last updated: July 19, 2012
Last verified: July 2012
  Purpose

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 Intervention Phase
Dermatomycoses
Drug: ciclopirox
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Ferrer Internacional S.A.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Explore clinical efficacy of topically applied ciclopirox olamine cream in patients with dermatomycoses. [ Time Frame: 0, 7, 14, 21 and 28 days ] [ Designated as safety issue: No ]
  • Explore mycological efficacy of topically applied ciclopirox olamine cream in patients with dermatomycoses [ Time Frame: 0, 7, 14, and 28 days ] [ Designated as safety issue: No ]
  • Explore relapse rate [ Time Frame: day 56 ] [ Designated as safety issue: No ]

Enrollment: 21
Study Start Date: October 2008
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   3 Months to 10 Years
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: NCT01646580

Sponsors and Collaborators
Ferrer Internacional S.A.
Investigators
Principal Investigator: Jose C Moreno, Prof, PhD Hospital Reina Sofia, Cordoba, Spain
  More Information

No publications provided

Responsible Party: Ferrer Internacional S.A.
ClinicalTrials.gov Identifier: NCT01646580     History of Changes
Other Study ID Numbers: CPO_08_01, 2008-003560-19
Study First Received: July 12, 2012
Last Updated: July 19, 2012
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Ferrer Internacional S.A.:
dermatomycoses, tinea, candidiasis, children

Additional relevant MeSH terms:
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
Skin Diseases
Ciclopirox
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014