Diaper RashPhase 4NCT00702507
Prospective Two-Year Study to Assess Miconazole Nitrate Resistance in Neonates and Infants
A Phase 4 study testing 0.25 % Miconazole Nitrate Ointment in people with Diaper Rash, run by Stiefel, a GSK Company at 8 sites in 4 countries.
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. Read more about this study
- Who is it for?
- Ages Up to 15 months
- Conditions the study is for
- Diaper Rash
- What is being tested?
- 0.25 % Miconazole Nitrate Ointment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 8 sitesin 4 countries
- Study dates
- May 2007to Dec 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 15 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
8 sites in 4 countries.
8 sites in 4 countries
United States5 sites
David Rodriguez, MD
Coral Gables, Florida, 33134
Wilson P. Andrews Jr., MD
Marietta, Georgia, 30062
Lawrence Schachner, MD
Miami, Florida, 33136
Lewis Purnell, MD
San Antonio, Texas, 78229
Sheila Fallon Friedlander, MD
San Diego, California, 92123
About this study
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
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.
Read the detailed 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.
- Conditions
- Diaper Rash
- Being tested
- 0.25 % Miconazole Nitrate Ointment
- Keywords
- Diaper dermatitis complicated by candidiasis
- Medical subject headings
- Diaper Rash
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.25 % Miconazole Nitrate OintmentDrug
Also called Vusion
Topical Application
| Study group | Role | What they receive |
|---|---|---|
| Miconazole Nitrate | Active comparator | Not described Receives: Drug: 0.25 % Miconazole Nitrate Ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Test-of-cure visit (Day 14) of initial treatment episode
Secondary outcomes (7)
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.
Measured: Test-of-cure visit (Day 14) of initial treatment episode
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.
Measured: Test-of-cure visit (Day 14) of initial treatment episode
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).
Measured: 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
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).
Measured: Test-of-cure visit (Day 14) of initial treatment episode
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.
Measured: Test-of-cure (TOC) visit (Day 14) of first to third recurrent episodes (up to approximately 1 year and 7 months)
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.
Measured: Test-of-cure visit (Day 14) of first to third recurrent episodes (up to approximately 1 year and 7 months)
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.
Measured: Test-of-cure visit (Day 14) of first to third recurrent episodes (up to approximately 1 year and 7 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2008 (estimated)
- Study startMay 2007
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diaper RashStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stiefel, a GSK Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00702507
- Sponsor's protocol ID
- 114678
- Other IDs
- BT0100-402-USA
- Status last verified
- Mar 2012
- First submitted
- 18 Jun 2008
- Last updated
- 27 Mar 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 23675632
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00702507
- Acronym / sponsor ID
- 114678
- Conditions
- Diaper Rash
- Keywords
- Diaper dermatitis complicated by candidiasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Stiefel, a GSK CompanyIndustry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Study start
- May 2007
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 20 Jun 2008 (estimated)
- Results
- Posted 7 Oct 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Miconazole Nitrate | Active comparator | Drug: 0.25 % Miconazole Nitrate Ointment |
Who may qualify
- Ages
- Up to 15 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0.25 % Miconazole Nitrate OintmentAlso: VusionTopical Application | Drug | Miconazole Nitrate |
Primary outcome
Number of Participants With Overall Cure (OC)
Time frame: Test-of-cure visit (Day 14) of initial treatment episode
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.
7 secondary outcomes
Number of Participants With Clinical Cure
Time frame: Test-of-cure visit (Day 14) of initial treatment episode
Number of Participants With Mycological Cure
Time frame: Test-of-cure visit (Day 14) of initial treatment episode
Clinical Evaluations Using the Diaper Dermatitis Severity Index Score for Initial Treatment Episode
Time frame: 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
Time frame: Test-of-cure visit (Day 14) of initial treatment episode
Number of Participants With Overall Cure (OC) of First to Third Recurrent Episodes (RE)
Time frame: Test-of-cure (TOC) visit (Day 14) of first to third recurrent episodes (up to approximately 1 year and 7 months)
Number of Participants With Clinical Cure of First to Third Recurrent Episodes
Time frame: Test-of-cure visit (Day 14) of first to third recurrent episodes (up to approximately 1 year and 7 months)
Number of Participants With Mycological Cure of First to Third Recurrent Episodes
Time frame: Test-of-cure visit (Day 14) of first to third recurrent episodes (up to approximately 1 year and 7 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23675632Blanco 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
8 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 0.25 % Miconazole Nitrate Ointment in people with Diaper Rash, run by Stiefel, a GSK Company at 8 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Dominican Republic, Ecuador, Panama. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Oct 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Overall Cure (OC) (time frame: Test-of-cure visit (Day 14) of initial treatment episode). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00702507, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2012.