Safety Study of Ciclopirox Olamine Cream for Dermatomycoses in Children

NCT01646580 | Terminated Phase 4

• 2 other identifiers: CPO_08_012008-003560-19
• Study Type: interventional
• Target: 21
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dermatomycoses

Keywords

dermatomycoses, tinea, candidiasis, children

Outcome Measures

Primary Outcomes (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.

  28 days

Secondary Outcomes (3)

• 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

Study Arms (1)

ciclopirox

EXPERIMENTAL

Drug: ciclopirox

Interventions

ciclopirox DRUG

Doses of 1.0% cream. Topical cream application. Twice daily for 28 days. Duration of treatment: 28 days with four weeks follow-up.

Also known as: Ciclochem

ciclopirox

Eligibility Criteria

• Age: 3 Months - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients from 3 months to 10 years of age.
• Obtention of the informed consent of the parents or legal representatives of the patients

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ferrer Internacional S.A.: lead

MeSH Terms

Conditions

Dermatomycoses; Tinea; Candidiasis

Interventions

Ciclopirox

Condition Hierarchy (Ancestors)

Mycoses; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Pyridones; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Jose C Moreno, Prof, PhD

  Hospital Reina Sofia, Cordoba, Spain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2012
• First Posted: July 20, 2012
• Study Start: October 1, 2008
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: July 20, 2012

Record last verified: 2012-07