Status:
COMPLETED
Selenium Sulfide, Ketoconazole and Ciclopirox Shampoo as Additional Treatments for Tinea Capitis (Scalp Ringworm)
Lead Sponsor:
Chen, Catherine, M.D.
Collaborating Sponsors:
Williams, Judith V., M.D.
Hubbard, Thomas W., M.D.
Conditions:
Tinea Capitis
Eligibility:
All Genders
12-12 years
Phase:
NA
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 g...
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 g...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT00127868
Start Date
March 1 2005
End Date
April 1 2008
Last Update
July 9 2008
Active Locations (1)
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1
Children's Hospital of the King's Daughters
Norfolk, Virginia, United States, 23507