Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:47 PM
Ignite Modification Date:
2025-12-24 @ 5:47 PM
NCT ID:
NCT00127868
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Months
Maximum Age:
12 Years
Study:
NCT00127868
Study Brief:
Protocol Section:
NCT00127868