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

Purpose

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	Intervention
Tinea Capitis	Drug: oral griseofulvin, selenium sulfide shampoo 1%, ciclopirox shampoo , ketoconazole shampoo 2%, baby shampoo


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

MedlinePlus related topics: Tinea Infections

Drug Information available for: Griseofulvin Selenomethionine Selenium sulfide Ciclopirox Ciclopirox olamine Ketoconazole

Genetic and Rare Diseases Information Center resources: Children's Interstitial Lung Disease

U.S. FDA Resources

Further study details as provided by Chen, Catherine, M.D.:

Primary Outcome Measures:

efficacy [ Time Frame: 9-10 months ] [ Designated as safety issue: No ]


Enrollment:	47
Study Start Date:	March 2005
Study Completion Date:	April 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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


Ages Eligible for Study:	12 Months to 12 Years
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00127868

Locations


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


Principal Investigator:	Catherine Chen, M.D.	Eastern Virginia Medical School

More Information

No publications provided


ClinicalTrials.gov Identifier:	NCT00127868 History of Changes
Other Study ID Numbers:	1-Chen
Study First Received:	August 5, 2005
Last Updated:	July 7, 2008
Health Authority:	United States: Institutional Review Board

Keywords provided by Chen, Catherine, M.D.:


Tinea Capitis Children Pediatric Treatment Therapy	Adjunctive Selenium Sulfide Ciclopirox Shampoo

Additional relevant MeSH terms:


Tinea Tinea Capitis Dermatomycoses Infection Mycoses Scalp Dermatoses Skin Diseases Skin Diseases, Infectious Ciclopirox Ketoconazole Selenium 14-alpha Demethylase Inhibitors	Anti-Infective Agents Antifungal Agents Antioxidants Enzyme Inhibitors Growth Substances Micronutrients Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Protective Agents Therapeutic Uses Trace Elements

ClinicalTrials.gov processed this record on February 26, 2015