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Efficacy Study of Selenium Sulfide Shampoo and Ciclopirox Shampoo as Additional Treatments for Tinea Capitis (Ringworm of the Scalp) in Children. - Article


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Ringworm Infection

Dermatophytosis; Ringworm of the body; Ringworm of the foot


Clinical Trial: Efficacy Study of Selenium Sulfide Shampoo and Ciclopirox Shampoo as Additional Treatments for Tinea Capitis (Ringworm of the Scalp) in Children.

This study is currently recruiting patients.
Verified by Chen, Catherine, M.D. January 2005

Sponsors and Collaborators: Chen, Catherine, M.D.
Williams, Judith V., M.D.
Hubbard, Thomas W., M.D.
Eastern Virginia Medical School, Department of Pediatrics, Faculty Research Development Fund
Eastern Virginia Medical School; Primary Care Research Infrastructure, Development, and Education Program
Information provided by: Chen, Catherine, M.D.
ClinicalTrials.gov Identifier: NCT00127868

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.

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 or ciclopirox shampoo twice a week for 8 weeks. They will return to clinic for scalp cultures at weeks 2, 4, and 8 of treatment. After 8 weeks, all treatment will be stopped (except for children who still have signs of tinea capitis, who will be treated for another 4 weeks). All patients will be seen 4 weeks after the end of treatment for follow-up.

Condition
Tinea Capitis

MedlinePlus related topics:  Skin Conditions;   Tinea Infections

Study Type: Observational
Study Design: Longitudinal, Defined Population, Prospective Study

Official Title: A Randomized, Double-Blinded Study Observing the Efficacy of 1% Selenium Sulfide Shampoo and 1% Ciclopirox Shampoo as Adjunctive Treatments for Tinea Capitis in Children.

Further Study Details: 

Study start: March 2005;  Expected completion: June 2006
Last follow-up: April 2006;  Data entry closure: June 2006

Eligibility

Ages Eligible for Study:  12 Months   -   12 Years,  Genders Eligible for Study:  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 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.

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00127868

Catherine Chen, M.D.      757-668-7842    ChenC@chkd.org
Judith V. Williams, M.D.      757-668-8922    WilliaJV@chkd.org

Virginia
      Children''''s Hospital of the King''''s Daughters, Norfolk,  Virginia,  23507,  United States; Recruiting
Catherine Chen, M.D.  757-668-7842    ChenC@chkd.org 
Judith V. Williams, M.D.  757-668-8922    WilliaJV@chkd.org 
Catherine Chen, M.D.,  Principal Investigator
Judith V. Williams, M.D.,  Sub-Investigator
Thomas W. Hubbard, M.D.,  Sub-Investigator

Study chairs or principal investigators

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

More Information

Study ID Numbers:  1
Last Updated:  August 8, 2005
Record first received:  August 5, 2005
ClinicalTrials.gov Identifier:  NCT00127868
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-08-23


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October 11, 2008



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