Prospective Two-Year Study to Assess Miconazole Nitrate Resistance in Neonates and Infants

NCT00702507 | Completed Phase 4 Results

• 2 other identifiers: 114678BT0100-402-USA
• Study Type: interventional
• Target: 200
• Locations: 4 countries
• Sites: 8

Brief Summary

The purpose of this study is to determine whether repeated use of 0.25% miconazole nitrate ointment in newborns and infants with a yeast infection in the diaper area causes the yeast to become resistant to the drug.

Conditions

Diaper Rash

Keywords

Diaper dermatitis complicated by candidiasis

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Overall Cure (OC)

  OC was defined as both clinical (therapeutic) cure with total resolution of signs/symptoms (no clinical signs of infection) and microbiological cure with mycological eradication (both negative potassium hydroxide \[KOH\] and culture results). Participants who had OC were categorized as "Successes"; those without OC were categorized as "Failures." Any discontinued or lost to follow-up participant was also considered a failure.

  Test-of-cure visit (Day 14) of initial treatment episode

Secondary Outcomes (7)

• Number of Participants With Clinical Cure

  Test-of-cure visit (Day 14) of initial treatment episode

• Number of Participants With Mycological Cure

  Test-of-cure visit (Day 14) of initial treatment episode

• Clinical Evaluations Using the Diaper Dermatitis Severity Index Score for Initial Treatment Episode

  Test-of-cure visit (Day 14) of initial treatment episode

• Clinical Evaluations Using Change From Baseline in the Dermatitis Severity Index Score at Day 14 of the Initial Treatment Episode

  Test-of-cure visit (Day 14) of initial treatment episode

• Number of Participants With Overall Cure (OC) of First to Third Recurrent Episodes (RE)

  Test-of-cure (TOC) visit (Day 14) of first to third recurrent episodes (up to approximately 1 year and 7 months)

Study Arms (1)

Miconazole Nitrate

ACTIVE COMPARATOR

Drug: 0.25 % Miconazole Nitrate Ointment

Interventions

0.25 % Miconazole Nitrate Ointment DRUG

Topical Application

Also known as: Vusion

Miconazole Nitrate

Eligibility Criteria

• Age: Up to 15 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Male or female neonate or infant up to 1 year of age with Fitzpatrick Skin Type I-VI
• Clinical evidence of diaper dermatitis and a positive KOH result for pseudohyphae and/or budding yeast at baseline visit
• Overall Diaper Dermatitis Severity Index score at baseline visit of 4-8 (must include an overall clinical grade of at least 2 for erythema)
• Wear commercially available diapers day and night for at least 7 days prior to enrollment and during the course of the 2 year study
• Caretaker must complete informed consent process

You may not qualify if:

• Known sensitivity to any component of the formulation
• No other skin conditions that may confound the evaluation of the drug efficacy or tolerability
• Known sensitivity to skin care toiletry products or diapers
• History of HIV positive
• Chronic illnesses that require systemic medication that may confound the evaluation of study drug efficacy or tolerability (antibiotic therapy is not included)
• Treatment with a prescription product for diaper dermatitis or other skin condition 7 days prior to enrollment

Sponsors & Collaborators

• Stiefel, a GSK Company: lead
• GlaxoSmithKline: collaborator

Study Sites (8)

Sheila Fallon Friedlander, MD

San Diego, California, 92123, United States

Location

David Rodriguez, MD

Coral Gables, Florida, 33134, United States

Location

Lawrence Schachner, MD

Miami, Florida, 33136, United States

Location

Wilson P. Andrews Jr., MD

Marietta, Georgia, 30062, United States

Location

Lewis Purnell, MD

San Antonio, Texas, 78229, United States

Location

Daisy Blanco, MD

Santo Domingo, Dominican Republic

Location

Manuel Briones, MD

Guayaquil, Ecuador

Location

Zila Espinosa, MD

Panama City, Panama

Location

Related Publications (1)

• Blanco D, van Rossem K. A prospective two-year assessment of miconazole resistance in Candida spp. With repeated treatment with 0.25% miconazole nitrate ointment in neonates and infants with moderate to severe diaper dermatitis complicated by cutaneous candidiasis. Pediatr Dermatol. 2013 Nov-Dec;30(6):717-24. doi: 10.1111/pde.12107. Epub 2013 May 16.

  PMID: 23675632 DERIVED

MeSH Terms

Conditions

Diaper Rash

Condition Hierarchy (Ancestors)

Dermatitis, Irritant; Dermatitis, Contact; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: June 18, 2008
• First Posted: June 20, 2008
• Study Start: May 1, 2007
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: March 27, 2012
• Results First Posted: October 7, 2011

Record last verified: 2012-03

Locations

PA (1); EC (1); US (5); DO (1)