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Sponsors and Collaborators: |
Chen, Catherine, M.D. Williams, Judith V., M.D. Hubbard, Thomas W., M.D. Eastern Virginia Medical School |
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Information provided by: | Chen, Catherine, M.D. |
ClinicalTrials.gov Identifier: | NCT00127868 |
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.
Condition | Intervention |
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Tinea Capitis |
Drug: oral griseofulvin, selenium sulfide shampoo 1%, ciclopirox shampoo , ketoconazole shampoo 2%, baby shampoo |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
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 |
Enrollment: | 47 |
Study Start Date: | March 2005 |
Study Completion Date: | April 2008 |
Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
oral griseofulvin and selenium sulfide shampoo 1%
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Drug: oral griseofulvin, selenium sulfide shampoo 1%, ciclopirox shampoo , ketoconazole shampoo 2%, baby shampoo |
2: Active Comparator
oral griseofulvin and ciclopirox shampoo
|
Drug: oral griseofulvin, selenium sulfide shampoo 1%, ciclopirox shampoo , ketoconazole shampoo 2%, baby shampoo |
3: Active Comparator
oral griseofulvin and ketoconazole shampoo 2%
|
Drug: oral griseofulvin, selenium sulfide shampoo 1%, ciclopirox shampoo , ketoconazole shampoo 2%, baby shampoo |
4: Placebo Comparator
oral griseofulvin and baby shampoo
|
Drug: oral griseofulvin, selenium sulfide shampoo 1%, ciclopirox shampoo , ketoconazole shampoo 2%, baby shampoo |
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.
Ages Eligible for Study: | 12 Months to 12 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
The following exclusion criteria are based upon the package insert for griseofulvin microsize suspension:
United States, Virginia | |
Children's Hospital of the King's Daughters | |
Norfolk, Virginia, United States, 23507 |
Principal Investigator: | Catherine Chen, M.D. | Eastern Virginia Medical School |
Study ID Numbers: | 1-Chen |
Study First Received: | August 5, 2005 |
Last Updated: | July 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00127868 |
Health Authority: | United States: Institutional Review Board |
Tinea Capitis Children Pediatric Treatment Therapy |
Adjunctive Selenium Sulfide Ciclopirox Shampoo |
Skin Diseases Clotrimazole Miconazole Tioconazole Ketoconazole Mycoses Selenium |
Skin Diseases, Infectious Ciclopirox Tinea Capitis Griseofulvin Tinea Dermatomycoses |
Anti-Infective Agents Antioxidants Molecular Mechanisms of Pharmacological Action Growth Substances Physiological Effects of Drugs Trace Elements Infection |
Protective Agents Pharmacologic Actions Antifungal Agents Therapeutic Uses Antibiotics, Antifungal Scalp Dermatoses Micronutrients |