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A Study Of Diflucan In Children With Ringworm Of The Scalp

Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00645242
Collaborator
(none)
185
Enrollment
31
Locations
1
Arm
3.9
Duration (Months)
6
Patients Per Site
1.5
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
185 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open Label, Multicenter Trial Of Diflucan (Fluconazole) For 6 Weeks Given Once Daily To Pediatric Patients With Tinea Capitis
Study Start Date :
Nov 1, 2002
Actual Study Completion Date :
Mar 1, 2003

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm A

Drug: fluconazole
Fluconazole oral suspension 6 mg/kg/day for 6 weeks followed by 4 weeks without treatment

Outcome Measures

Primary Outcome Measures

  1. Combined clinical and mycological outcome at Week 6 [Week 6]

Secondary Outcome Measures

  1. Clinical outcome based on signs and symptoms at Weeks 3, 6, and 10 [Weeks 3, 6, and 10]

  2. Combined clinical and mycological outcome at Weeks 3 and 10 [Weeks 3 and 10]

  3. Mycological outcome based on culture results at Weeks 3, 6, and 10 [Weeks 3, 6, and 10]

  4. Culture results at Weeks 3, 6, and 10 [Weeks 3, 6, and 10]

Eligibility Criteria

Criteria

Ages Eligible for Study:
3 Years to 12 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Pediatric patients (aged 3-12 years)

  • Clinical diagnosis of tinea capitis

  • Direct microscopy (KOH) positive for fungal elements within or outside hair shaft

Exclusion Criteria:

  • Negative baseline KOH

  • Liver disease

Contacts and Locations

Locations

Site City State Country Postal Code
1 Pfizer Investigational Site Montgomery Alabama United States 36116
2 Pfizer Investigational Site Little Rock Arkansas United States 72205
3 Pfizer Investigational Site San Diego California United States 92123
4 Pfizer Investigational Site Miami Florida United States 33156-7712
5 Pfizer Investigational Site Miami Florida United States 33156
6 Pfizer Investigational Site Martinez Georgia United States 30907
7 Pfizer Investigational Site Chicago Illinois United States 60630
8 Pfizer Investigational Site Evanston Illinois United States 60202
9 Pfizer Investigational Site Gretna Louisiana United States 70056
10 Pfizer Investigational Site New Orleans Louisiana United States 70119
11 Pfizer Investigational Site Shreveport Louisiana United States 71105
12 Pfizer Investigational Site Detroit Michigan United States 48201
13 Pfizer Investigational Site Fridley Minnesota United States 55432
14 Pfizer Investigational Site Bridgeton Missouri United States 63044
15 Pfizer Investigational Site Brooklyn New York United States 11203-2098
16 Pfizer Investigational Site Garner North Carolina United States 27529
17 Pfizer Investigational Site Raleigh North Carolina United States 27609
18 Pfizer Investigational Site Cleveland Ohio United States 44106
19 Pfizer Investigational Site Columbus Ohio United States 43205
20 Pfizer Investigational Site Mount Pleasant South Carolina United States 29464
21 Pfizer Investigational Site Knoxville Tennessee United States 37927
22 Pfizer Investigational Site Murfreesboro Tennessee United States 37130
23 Pfizer Investigational Site Nashville Tennessee United States 37215
24 Pfizer Investigational Site Houston Texas United States 77056
25 Pfizer Investigational Site San Antonio Texas United States 78205
26 Pfizer Investigational Site San Antonio Texas United States 78224
27 Pfizer Investigational Site San Antonio Texas United States 78229
28 Pfizer Investigational Site Norfolk Virginia United States 23507
29 Pfizer Investigational Site Carolina Puerto Rico 00985
30 Pfizer Investigational Site Ponce Puerto Rico 00717-2115
31 Pfizer Investigational Site Ponce Puerto Rico 99717

Sponsors and Collaborators

  • Pfizer

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT00645242
Other Study ID Numbers:
  • A0561017
First Posted:
Mar 27, 2008
Last Update Posted:
Jul 16, 2021
Last Verified:
Jul 1, 2021
Additional relevant MeSH terms:
Tinea
Tinea Capitis
Fluconazole

Study Results

No Results Posted as of Jul 16, 2021