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

Diaper Rash Clinical Trial

Official title:

Prospective 2-Year Longitudinal Study to Assess for Miconazole Resistance in Candida Spp. With Repeated Treatment Courses of 0.25% Miconazole Nitrate Ointment in Neonates and Infants up to 1 Year of Age With Recurrent Moderate-Severe Diaper Dermatitis Complicated by Cutaneous Candidiasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00702507
• Other study ID #: 114678
• Secondary ID: BT0100-402-USA
• Status: Completed
• Phase: Phase 4
• First received: June 18, 2008
• Last updated: March 22, 2012
• Start date: May 2007
• Est. completion date: December 2010

Study information

• Verified date: March 2012
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

The objective of this study is to investigate the potential for the development of resistance in Candida spp. after repeated treatment courses of 0.25% miconazole nitrate ointment in neonates and infants up to one year of age.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 15 Months

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diaper Rash

Intervention

Drug:
• 0.25 % Miconazole Nitrate Ointment
Topical Application

Locations

Country	Name	City	State
Dominican Republic	Daisy Blanco, MD	Santo Domingo
Ecuador	Manuel Briones, MD	Guayaquil
Panama	Zila Espinosa, MD	Panama City
United States	David Rodriguez, MD	Coral Gables	Florida
United States	Wilson P. Andrews Jr., MD	Marietta	Georgia
United States	Lawrence Schachner, MD	Miami	Florida
United States	Lewis Purnell, MD	San Antonio	Texas
United States	Sheila Fallon Friedlander, MD	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
Stiefel, a GSK Company	GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Dominican Republic,  Ecuador,  Panama, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Number of Participants With Clinical Cure	Participants were evaluated for clinical cure, which was defined as therapeutic cure with total resolution of signs and symptoms (i.e., no clinical signs of infection). Participants who had clinical cure were categorized as "Successes"; those without clianical cure 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	No
Secondary	Number of Participants With Mycological Cure	Participants were evaluated for mycological cure, which was defined as mycological eradication with negative KOH and culture results. Participants who had mycological cure were categorized as "Successes"; those without mycological cure 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	No
Secondary	Clinical Evaluations Using the Diaper Dermatitis Severity Index Score for Initial Treatment Episode	The diaper dermatitis severity index score was calculated as the sum of severity grades for each parameter evaluated (erythema, papules or pustules, and erosions) for the initial treatment episode. The maximum score possible for the diaper dermatitis severity index is 8. Rating scale for Erythema: 0 (none to trace), 1 (mild [pink]), 2 (moderate [red]), 3 (severe [beefy red]). Rating scale for Papules or Pustules: 0 (none to trace [0]), 1 (few [1-10]), 2 (multiple [11-20]), 3 (many [21-40]), 4 (abundant [more than 40]. Rating scale for Erosions: 0 (absent), 1 (present).	Test-of-cure visit (Day 14) of initial treatment episode	No
Secondary	Clinical Evaluations Using Change From Baseline in the Dermatitis Severity Index Score at Day 14 of the Initial Treatment Episode	The diaper dermatitis severity index score was calculated as the sum of severity grades for each parameter evaluated (erythema, papules or pustules, and erosions). Change from baseline=baseline value minus Day 14 value. The maximum score possible for the diaper dermatitis severity index is 8. Rating scale for Erythema: 0 (none to trace), 1 (mild [pink]), 2 (moderate [red]), 3 (severe [beefy red]). Rating scale for Papules or Pustules: 0 (none to trace [0]), 1 (few [1-10]), 2 (multiple [11-20]), 3 (many [21-40]), 4 (abundant [more than 40]. Rating scale for Erosions: 0 (absent), 1 (present).	Test-of-cure visit (Day 14) of initial treatment episode	No
Secondary	Number of Participants With Overall Cure (OC) of First to Third Recurrent Episodes (RE)	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 and culture results) at TOC visit for initial episode (ep.) to third ep. Participants (par) who had OC were categorized as "Successes"; those without OC were categorized as "Failures" (discontinued/lost to follow-up par were also failures). A RE is not temporally associated with a prior episode (PE) irrespective of whether the PE involves continuing treatment with study medication.	Test-of-cure (TOC) visit (Day 14) of first to third recurrent episodes (up to approximately 1 year and 7 months)	No
Secondary	Number of Participants With Clinical Cure of First to Third Recurrent Episodes	Participants were evaluated for clinical cure, which was defined as therapeutic cure with total resolution of signs and symptoms (i.e., no clinical signs of infection). Participants who had clinical cure were categorized as "Successes"; those without clinical cure were categorized as "Failures." Any discontinued or lost to follow-up participant was also considered a failure.	Test-of-cure visit (Day 14) of first to third recurrent episodes (up to approximately 1 year and 7 months)	No
Secondary	Number of Participants With Mycological Cure of First to Third Recurrent Episodes	Participants were evaluated for mycological cure, which was defined as mycological eradication with negative KOH and culture results. Participants who had mycological cure were categorized as "Successes"; those without mycological cure were categorized as "Failures." Any discontinued or lost to follow-up participant was also considered a failure.	Test-of-cure visit (Day 14) of first to third recurrent episodes (up to approximately 1 year and 7 months)	No