Selenium Sulfide, Ketoconazole and Ciclopirox Shampoo as Additional Treatments for Tinea Capitis (Scalp Ringworm)
Information source: Chen, Catherine, M.D.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Tinea Capitis
Intervention: oral griseofulvin, selenium sulfide shampoo 1%, ciclopirox shampoo , ketoconazole shampoo 2%, baby shampoo (Drug)
Phase: N/A
Status: Completed
Sponsored by: Chen, Catherine, M.D. Official(s) and/or principal investigator(s): Catherine Chen, M.D., Principal Investigator, Affiliation: Eastern Virginia Medical School
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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: efficacy
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 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.
Eligibility
Minimum age: 12 Months.
Maximum age: 12 Years.
Gender(s): Both.
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.
Locations and Contacts
Children's Hospital of the King's Daughters, Norfolk, Virginia 23507, United States
Additional Information
Starting date: March 2005
Last updated: July 7, 2008
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