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

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

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 Overview

• Status: Completed
• Conditions: Tinea Capitis
• Intervention / Treatment: Drug: oral griseofulvin, selenium sulfide shampoo 1%, ciclopirox shampoo , ketoconazole shampoo 2%, baby shampoo

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 Type: Interventional
• Enrollment (Actual): 47
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Children's Hospital of The King's Daughters

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
efficacy	9-10 months

Collaborators and Investigators

• Sponsor: Chen, Catherine, M.D.
• Collaborators: Eastern Virginia Medical School; Williams, Judith V., M.D.; Hubbard, Thomas W., M.D.
• Investigators: Principal Investigator: Catherine Chen, M.D., Eastern Virginia Medical School

Study record dates

Study Major Dates

• Study Start: March 1, 2005
• Primary Completion (Actual): April 1, 2008
• Study Completion (Actual): April 1, 2008

Study Registration Dates

• First Submitted: August 5, 2005
• First Submitted That Met QC Criteria: August 8, 2005
• First Posted (Estimate): August 9, 2005

Study Record Updates

• Last Update Posted (Estimate): July 9, 2008
• Last Update Submitted That Met QC Criteria: July 7, 2008
• Last Verified: May 1, 2006

More Information

Terms related to this study

• Keywords: Treatment; Children; Pediatric; Therapy; Tinea Capitis; Adjunctive; Selenium Sulfide; Ciclopirox; Shampoo
• Additional Relevant MeSH Terms: Skin Diseases; Infections; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Mycoses; Dermatomycoses; Scalp Dermatoses; Tinea; Tinea Capitis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Protective Agents; Dermatologic Agents; Trace Elements; Micronutrients; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Hormone Antagonists; Antifungal Agents; Steroid Synthesis Inhibitors; Antioxidants; 14-alpha Demethylase Inhibitors; Ketoconazole; Griseofulvin; Selenium; Ciclopirox; Selenium disulfide
• Other Study ID Numbers: 1-Chen

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No