Clinical Trial: Safety Study of Ciclopirox Olamine Cream for Dermatomycoses in Children

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Study for the Assessment of Safety and Efficacy of Ciclopirox Olamine Cream in 3 Months to 10 Years Old Children With Dermatomycoses

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.

Detailed Summary: 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.
Sponsor: Ferrer Internacional S.A.

Current 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 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: Ferrer Internacional S.A.

Dates:
Date Received: July 12, 2012
Date Started: October 2008
Date Completion:
Last Updated: July 19, 2012
Last Verified: July 2012