Selenium Sulfide, Ketoconazole and Ciclopirox Shampoo as Additional Treatments for Tinea Capitis … (NCT00127868) | Clinical Trial Compass
CompletedNot Applicable
Selenium Sulfide, Ketoconazole and Ciclopirox Shampoo as Additional Treatments for Tinea Capitis (Scalp Ringworm)
United States47 participantsStarted 2005-03
Plain-language 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.
Who can participate
Age range
12 Months – 12 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.