Tinea CapitisPhase 3NCT00645242
A Study Of Diflucan In Children With Ringworm Of The Scalp
A Phase 3 study testing fluconazole in people with Tinea Capitis, run by Pfizer at 31 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of fluconazole for the treatment of tinea capitis in pediatric patients aged 3 to 12 years. Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Tinea Capitis
- What is being tested?
- fluconazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 185 participants
- Where
- 31 sitesin 2 countries
- Study dates
- Nov 2002to Mar 2003
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric patients (aged 3-12 years)
- Clinical diagnosis of tinea capitis
- Direct microscopy (KOH) positive for fungal elements within or outside hair shaft
Who cannot join
- Negative baseline KOH
- Liver disease
Trial locations and contacts
31 sites in 2 countries.
31 sites in 2 countries
United States28 sites
Pfizer Investigational Site
Bridgeton, Missouri, 63044
Pfizer Investigational Site
Brooklyn, New York, 11203-2098
Pfizer Investigational Site
Chicago, Illinois, 60630
Pfizer Investigational Site
Cleveland, Ohio, 44106
Pfizer Investigational Site
Columbus, Ohio, 43205
Pfizer Investigational Site
Detroit, Michigan, 48201
Pfizer Investigational Site
Evanston, Illinois, 60202
Pfizer Investigational Site
Fridley, Minnesota, 55432
Pfizer Investigational Site
Garner, North Carolina, 27529
Pfizer Investigational Site
Gretna, Louisiana, 70056
Pfizer Investigational Site
Houston, Texas, 77056
Pfizer Investigational Site
Knoxville, Tennessee, 37927
Pfizer Investigational Site
Little Rock, Arkansas, 72205
Pfizer Investigational Site
Martinez, Georgia, 30907
Pfizer Investigational Site
Miami, Florida, 33156-7712
Pfizer Investigational Site
Miami, Florida, 33156
Pfizer Investigational Site
Montgomery, Alabama, 36116
Pfizer Investigational Site
Mt. Pleasant, South Carolina, 29464
Pfizer Investigational Site
Murfreesboro, Tennessee, 37130
Pfizer Investigational Site
Nashville, Tennessee, 37215
Pfizer Investigational Site
New Orleans, Louisiana, 70119
Pfizer Investigational Site
Norfolk, Virginia, 23507
Pfizer Investigational Site
Raleigh, North Carolina, 27609
Pfizer Investigational Site
San Antonio, Texas, 78205
Pfizer Investigational Site
San Antonio, Texas, 78224
Pfizer Investigational Site
San Antonio, Texas, 78229
Pfizer Investigational Site
San Diego, California, 92123
Pfizer Investigational Site
Shreveport, Louisiana, 71105
Puerto Rico3 sites
Pfizer Investigational Site
Carolina, 00985
Pfizer Investigational Site
Ponce, 00717-2115
Pfizer Investigational Site
Ponce, 99717
About this study
Official title: An Open Label, Multicenter Trial Of Diflucan (Fluconazole) For 6 Weeks Given Once Daily To Pediatric Patients With Tinea Capitis
The purpose of this study is to evaluate the safety and efficacy of fluconazole for the treatment of tinea capitis in pediatric patients aged 3 to 12 years.
- Conditions
- Tinea Capitis
- Being tested
- fluconazole
- Medical subject headings
- Tinea Capitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluconazoleDrug
Fluconazole oral suspension 6 mg/kg/day for 6 weeks followed by 4 weeks without treatment
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Not described Receives: Drug: fluconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Combined clinical and mycological outcome at Week 6
Measured: Week 6
Secondary outcomes (4)
Clinical outcome based on signs and symptoms at Weeks 3, 6, and 10
Measured: Weeks 3, 6, and 10
Combined clinical and mycological outcome at Weeks 3 and 10
Measured: Weeks 3 and 10
Mycological outcome based on culture results at Weeks 3, 6, and 10
Measured: Weeks 3, 6, and 10
Culture results at Weeks 3, 6, and 10
Measured: Weeks 3, 6, and 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2008 (estimated)
- Study startNov 2002
- Study completionMar 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tinea CapitisStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 185 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00645242
- Sponsor's protocol ID
- A0561017
- Status last verified
- Jul 2021
- First submitted
- 25 Mar 2008
- Last updated
- 16 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Multicenter Trial Of Diflucan (Fluconazole) For 6 Weeks Given Once Daily To Pediatric Patients With Tinea Capitis
- ClinicalTrials.gov ID
- NCT00645242
- Acronym / sponsor ID
- A0561017
- Conditions
- Tinea Capitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 185 participants (estimated)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Nov 2002
- Study completion
- Mar 2003 (actual)
- First posted
- 27 Mar 2008 (estimated)
- Results
- Not posted in the source record
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 evaluate the safety and efficacy of fluconazole for the treatment of tinea capitis in pediatric patients aged 3 to 12 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: fluconazole |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Pediatric patients (aged 3-12 years)
- Clinical diagnosis of tinea capitis
- Direct microscopy (KOH) positive for fungal elements within or outside hair shaft
Key exclusion criteria (2 listed)
- Negative baseline KOH
- Liver disease
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 |
|---|---|---|
| fluconazoleFluconazole oral suspension 6 mg/kg/day for 6 weeks followed by 4 weeks without treatment | Drug | Arm A |
Primary outcome
Combined clinical and mycological outcome at Week 6
Time frame: Week 6
4 secondary outcomes
Clinical outcome based on signs and symptoms at Weeks 3, 6, and 10
Time frame: Weeks 3, 6, and 10
Combined clinical and mycological outcome at Weeks 3 and 10
Time frame: Weeks 3 and 10
Mycological outcome based on culture results at Weeks 3, 6, and 10
Time frame: Weeks 3, 6, and 10
Culture results at Weeks 3, 6, and 10
Time frame: Weeks 3, 6, and 10
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2021.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Efficacy and Safety of Topical Amphotericin B Solution in Treatment of Resistant Tinea Capitis in Children 16 Years Old or Less we Follow up Cases Weekly up to 8 Weeks and Notice Improvement of Itching ,Scaling, and Hair Regrowth Then Fungal Culture Done to See if the Solution Working
Tinea Capitis
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.
Pfizer CT.gov Call Center study director
Pfizer
31 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing fluconazole in people with Tinea Capitis, run by Pfizer at 31 sites in 2 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 3 inclusion and 2 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 16 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States, Puerto Rico. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Combined clinical and mycological outcome at Week 6 (time frame: Week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jul 2021.