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Selenium Sulfide, Ketoconazole and Ciclopirox Shampoo as Additional Treatments for Tinea Capitis (Scalp Ringworm)

Primary Purpose

Tinea Capitis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
oral griseofulvin, selenium sulfide shampoo 1%, ciclopirox shampoo , ketoconazole shampoo 2%, baby shampoo
Sponsored by
Chen, Catherine, M.D.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tinea Capitis focused on measuring Tinea Capitis, Children, Pediatric, Treatment, Therapy, Adjunctive, Selenium Sulfide, Ciclopirox, Shampoo

Eligibility Criteria

12 Months - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients with clinically diagnosed tinea capitis. Males or females, ages 1 through 12 years old. Females of childbearing potential must have a negative pregnancy test. Written Informed Consent must be obtained prior to performing any study- related procedure and according to local regulations. Patients must be available for the entire study duration. Exclusion Criteria: Patients who are pregnant or breast-feeding. Patients who have kerions requiring immediate treatment or treatment with systemic corticosteroids and/or systemic antibiotics. Patients who have a skin disease involving the scalp, or any other condition or prior/present treatment which in the opinion of the investigator would interfere with evaluation of the treatment's effect. Examples include head lice, scalp psoriasis, atopic dermatitis of the scalp, or seborrheic dermatitis. Patients with known liver disease. Patients with non-acidic gastroduodenitis, malabsorption syndrome, chronic diarrhea, or any other serious gastrointestinal (GI) disease. Patients who have received systemic antifungal treatment within 2 months prior to baseline. Patients who have received the following topical treatments for their scalp within 1 week prior to baseline: antifungal agents, corticosteroids, zinc pyrithione, selenium sulfide, or tar-containing products. Patients who have received immunosuppressant therapy, cytostatic therapy, or underwent radiation therapy within 1 month prior to baseline. Patients who have been treated with any investigational agent within 8 weeks prior to baseline or who intend to use other investigational treatments during this study. Patients with hypersensitivity to griseofulvin, selenium sulfide, or ciclopirox. Patients who are known to miss appointments (per medical records), unlikely to follow medical instructions, or not willing to attend regular visits. The following exclusion criteria are based upon the package insert for griseofulvin microsize suspension: Males planning to father children during their participation in the study or in the 6 months following their completion of the study. Patients taking substances known to interact with griseofulvin. Patients with systemic lupus erythematosus. Patients with porphyria. Patients with photosensitivity.

Sites / Locations

  • Children's Hospital of the King's Daughters

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

1

2

3

4

Arm Description

oral griseofulvin and selenium sulfide shampoo 1%

oral griseofulvin and ciclopirox shampoo

oral griseofulvin and ketoconazole shampoo 2%

oral griseofulvin and baby shampoo

Outcomes

Primary Outcome Measures

efficacy

Secondary Outcome Measures

Full Information

First Posted
August 5, 2005
Last Updated
July 7, 2008
Sponsor
Chen, Catherine, M.D.
Collaborators
Williams, Judith V., M.D., Hubbard, Thomas W., M.D., Eastern Virginia Medical School
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1. Study Identification

Unique Protocol Identification Number
NCT00127868
Brief Title
Selenium Sulfide, Ketoconazole and Ciclopirox Shampoo as Additional Treatments for Tinea Capitis (Scalp Ringworm)
Official Title
A Randomized, Double-Blinded, Placebo-Controlled Study Observing the Efficacy of Selenium Sulfide 1% Shampoo, Ketoconazole 2% Shampoo, and Ciclopirox 1% Shampoo as Adjunctive Treatments for Tinea Capitis in Children
Study Type
Interventional

2. Study Status

Record Verification Date
May 2006
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Chen, Catherine, M.D.
Collaborators
Williams, Judith V., M.D., Hubbard, Thomas W., M.D., Eastern Virginia Medical School

4. Oversight

5. Study Description

Brief Summary
Antifungal shampoos have been used as supplements to oral griseofulvin to help eradicate tinea capitis (also known as ringworm of the scalp) more quickly. While selenium sulfide shampoo has been the gold standard, its strong odor and its drying effect on the scalp discourage many patients from using it. Meanwhile, no other antifungal shampoo has been rigorously evaluated for efficacy. Therefore, while physicians are prescribing griseofulvin accompanied by any of a number of antifungal shampoos for tinea capitis, it is not known which antifungal shampoos (excluding selenium sulfide) actually significantly reduce time to cure, nor which do so the fastest. Scalp ringworm can also re-occur in the same child. To date, no studies have been done to find out whether or not the use of antifungal shampoos can prevent the recurrence of scalp ringworm. In this study, children ages 1-12 years old, who have clinically diagnosed tinea capitis, will all be prescribed oral griseofulvin for 8 weeks. In addition, they will be randomly assigned to use either selenium sulfide shampoo, ketoconazole shampoo, ciclopirox shampoo, or baby shampoo twice a week for 8 weeks. After 8 weeks, griseofulvin will be stopped. All patients will continue using the same assigned shampoo twice weekly for 24 weeks, while continuing to return to clinic every 4 weeks for scalp evaluation.
Detailed Description
Antifungal shampoos have been used as supplements to oral griseofulvin to help eradicate tinea capitis (also known as ringworm of the scalp) more quickly. While selenium sulfide shampoo has been the gold standard, its strong odor and its drying effect on the scalp discourage many patients from using it. Meanwhile, no other antifungal shampoo has been rigorously evaluated for efficacy. Therefore, while physicians are prescribing griseofulvin accompanied by any of a number of antifungal shampoos for tinea capitis, it is not known which antifungal shampoos (excluding selenium sulfide) actually significantly reduce time to cure, nor which do so the fastest. Scalp ringworm can also re-occur in the same child. To date, no studies have been done to find out whether or not the use of antifungal shampoos can prevent the recurrence of scalp ringworm. In this study, children ages 1-12 years old, who have clinically diagnosed tinea capitis, will all be prescribed oral griseofulvin for 8 weeks. In addition, they will be randomly assigned to use either selenium sulfide shampoo, ketoconazole shampoo, ciclopirox shampoo, or baby shampoo twice a week for 8 weeks. After 8 weeks, griseofulvin will be stopped. All patients will continue using the same assigned shampoo twice weekly for 24 weeks, while continuing to return to clinic every 4 weeks for scalp evaluation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinea Capitis
Keywords
Tinea Capitis, Children, Pediatric, Treatment, Therapy, Adjunctive, Selenium Sulfide, Ciclopirox, Shampoo

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
oral griseofulvin and selenium sulfide shampoo 1%
Arm Title
2
Arm Type
Active Comparator
Arm Description
oral griseofulvin and ciclopirox shampoo
Arm Title
3
Arm Type
Active Comparator
Arm Description
oral griseofulvin and ketoconazole shampoo 2%
Arm Title
4
Arm Type
Placebo Comparator
Arm Description
oral griseofulvin and baby shampoo
Intervention Type
Drug
Intervention Name(s)
oral griseofulvin, selenium sulfide shampoo 1%, ciclopirox shampoo , ketoconazole shampoo 2%, baby shampoo
Primary Outcome Measure Information:
Title
efficacy
Time Frame
9-10 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with clinically diagnosed tinea capitis. Males or females, ages 1 through 12 years old. Females of childbearing potential must have a negative pregnancy test. Written Informed Consent must be obtained prior to performing any study- related procedure and according to local regulations. Patients must be available for the entire study duration. Exclusion Criteria: Patients who are pregnant or breast-feeding. Patients who have kerions requiring immediate treatment or treatment with systemic corticosteroids and/or systemic antibiotics. Patients who have a skin disease involving the scalp, or any other condition or prior/present treatment which in the opinion of the investigator would interfere with evaluation of the treatment's effect. Examples include head lice, scalp psoriasis, atopic dermatitis of the scalp, or seborrheic dermatitis. Patients with known liver disease. Patients with non-acidic gastroduodenitis, malabsorption syndrome, chronic diarrhea, or any other serious gastrointestinal (GI) disease. Patients who have received systemic antifungal treatment within 2 months prior to baseline. Patients who have received the following topical treatments for their scalp within 1 week prior to baseline: antifungal agents, corticosteroids, zinc pyrithione, selenium sulfide, or tar-containing products. Patients who have received immunosuppressant therapy, cytostatic therapy, or underwent radiation therapy within 1 month prior to baseline. Patients who have been treated with any investigational agent within 8 weeks prior to baseline or who intend to use other investigational treatments during this study. Patients with hypersensitivity to griseofulvin, selenium sulfide, or ciclopirox. Patients who are known to miss appointments (per medical records), unlikely to follow medical instructions, or not willing to attend regular visits. The following exclusion criteria are based upon the package insert for griseofulvin microsize suspension: Males planning to father children during their participation in the study or in the 6 months following their completion of the study. Patients taking substances known to interact with griseofulvin. Patients with systemic lupus erythematosus. Patients with porphyria. Patients with photosensitivity.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine Chen, M.D.
Organizational Affiliation
Eastern Virginia Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of the King's Daughters
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States

12. IPD Sharing Statement

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Selenium Sulfide, Ketoconazole and Ciclopirox Shampoo as Additional Treatments for Tinea Capitis (Scalp Ringworm)

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