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Selenium Sulfide, Ketoconazole and Ciclopirox Shampoo as Additional Treatments for Tinea Capitis (Scalp Ringworm)

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ClinicalTrials.gov Identifier: NCT00127868
Recruitment Status : Completed
First Posted : August 9, 2005
Last Update Posted : July 9, 2008
Sponsor:
Collaborators:
Williams, Judith V., M.D.
Hubbard, Thomas W., M.D.
Eastern Virginia Medical School
Information provided by:
Chen, Catherine, M.D.

Study Description
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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 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 or disease Intervention/treatment Phase
Tinea Capitis Drug: oral griseofulvin, selenium sulfide shampoo 1%, ciclopirox shampoo , ketoconazole shampoo 2%, baby shampoo Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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 Start Date : March 2005
Actual Primary Completion Date : April 2008
Actual Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tinea Infections

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 1
oral griseofulvin and selenium sulfide shampoo 1%
 Drug: oral griseofulvin, selenium sulfide shampoo 1%, ciclopirox shampoo , ketoconazole shampoo 2%, baby shampoo
Active Comparator: 2
oral griseofulvin and ciclopirox shampoo
 Drug: oral griseofulvin, selenium sulfide shampoo 1%, ciclopirox shampoo , ketoconazole shampoo 2%, baby shampoo
Active Comparator: 3
oral griseofulvin and ketoconazole shampoo 2%
 Drug: oral griseofulvin, selenium sulfide shampoo 1%, ciclopirox shampoo , ketoconazole shampoo 2%, baby shampoo
Placebo Comparator: 4
oral griseofulvin and baby shampoo
 Drug: oral griseofulvin, selenium sulfide shampoo 1%, ciclopirox shampoo , ketoconazole shampoo 2%, baby shampoo


Outcome Measures
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Primary Outcome Measures :
  1. efficacy [ Time Frame: 9-10 months ]

Eligibility Criteria
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Ages Eligible for Study:   12 Months to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00127868


Locations
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United States, Virginia
Children's Hospital of the King's Daughters
Norfolk, Virginia, United States, 23507
Sponsors and Collaborators
Chen, Catherine, M.D.
Williams, Judith V., M.D.
Hubbard, Thomas W., M.D.
Eastern Virginia Medical School
Investigators
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Principal Investigator: Catherine Chen, M.D. Eastern Virginia Medical School
More Information
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ClinicalTrials.gov Identifier: NCT00127868    
Other Study ID Numbers: 1-Chen
First Posted: August 9, 2005    Key Record Dates
Last Update Posted: July 9, 2008
Last Verified: May 2006
Keywords provided by Chen, Catherine, M.D.:
Tinea Capitis
Children
Pediatric
Treatment
Therapy
 Adjunctive
Selenium Sulfide
Ciclopirox
Shampoo
Additional relevant MeSH terms:
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Tinea
Tinea Capitis
Dermatomycoses
Mycoses
Bacterial Infections and Mycoses
Infections
Skin Diseases, Infectious
Skin Diseases
Scalp Dermatoses
Selenium
Ketoconazole
Ciclopirox
Griseofulvin
Selenium disulfide
Antifungal Agents
 Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors
Antioxidants
Protective Agents
Trace Elements
Micronutrients
Dermatologic Agents