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

NCT00127868 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2008-07-09

No results posted yet for this study

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.

Conditions

  • Tinea Capitis

Interventions

DRUG

oral griseofulvin, selenium sulfide shampoo 1%, ciclopirox shampoo , ketoconazole shampoo 2%, baby shampoo

Sponsors & Collaborators

  • Williams, Judith V., M.D.

    collaborator INDIV

  • Hubbard, Thomas W., M.D.

    collaborator INDIV

  • Eastern Virginia Medical School

    collaborator OTHER

  • Chen, Catherine, M.D.

    lead OTHER

Principal Investigators

  • Catherine Chen, M.D. · Eastern Virginia Medical School

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
12 Months
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-03-31
Primary Completion
2008-04-30
Completion
2008-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00127868 on ClinicalTrials.gov