Safety Study of Ciclopirox Olamine Cream for Dermatomycoses in Children

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.

Study Overview

• Status: Terminated
• Conditions: Dermatomycoses
• Intervention / Treatment: Drug: ciclopirox

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 Type: Interventional
• Enrollment (Actual): 21
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 8 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: Ciclochem

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To evaluate skin lesion condition as a measure of safety and tolerability of ciclopirox olamine treated dermatomycoses patients from 3 months to 10 years.	28 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Explore clinical efficacy of topically applied ciclopirox olamine cream in patients with dermatomycoses.	0, 7, 14, 21 and 28 days
Explore mycological efficacy of topically applied ciclopirox olamine cream in patients with dermatomycoses	0, 7, 14, and 28 days
Explore relapse rate	day 56

Collaborators and Investigators

• Sponsor: Ferrer Internacional S.A.
• Investigators: Principal Investigator: Jose C Moreno, Prof, PhD, Hospital Reina Sofia, Cordoba, Spain

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): November 1, 2011
• Study Completion (Actual): November 1, 2011

Study Registration Dates

• First Submitted: July 12, 2012
• First Submitted That Met QC Criteria: July 19, 2012
• First Posted (Estimate): July 20, 2012

Study Record Updates

• Last Update Posted (Estimate): July 20, 2012
• Last Update Submitted That Met QC Criteria: July 19, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Keywords: dermatomycoses, tinea, candidiasis, children
• Additional Relevant MeSH Terms: Skin Diseases; Infections; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Mycoses; Dermatomycoses; Anti-Infective Agents; Antifungal Agents; Ciclopirox
• Other Study ID Numbers: CPO_08_01; 2008-003560-19 (EudraCT Number)