Seborrheic Dermatitis: Ketoconazole 2% Foam Versus Ketoconazole 2% Shampoo

Last updated: October 3, 2017
Sponsor: St. Louis University
Overall Status: Completed

Phase

N/A

Condition

Allergy

Seborrhea

Rash

Treatment

N/A

Clinical Study ID

NCT01203189
seb derm 2010
  • Ages 18-89
  • Female
  • Accepts Healthy Volunteers

Study Summary

The aims of this study are to compare the effectiveness of antifungal foam versus antifungal shampoo and determine patient compliance and satisfaction with both vehicles among African American females with dandruff practicing less than once weekly hair washing.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • African American females aged 18 to 89 years

  • Previous diagnosis of seborrheic dermatitis of the scalp

  • TDSS between 50 and 200

  • Practice less than or equal to once weekly hair washing

  • Immunocompetent

  • Willing to not grease or oil scalp

Exclusion

Exclusion Criteria:

  • Age below 18 years or above 89 years

  • Medical history of psoriasis, diabetes mellitus, immunosuppression, neurologicdisorders, and/or chronic disease not stabilized by medication

  • Patients taking any oral steroids and/or antifungals within 30 days of enrollment

  • Sensitivity to any formulation components of either ketoconazole foam or shampooincluding sulfur

  • The use of any topical medications including over the counter products indicated forthe treatment of seborrheic dermatitis within 14 days of enrollment

  • Pregnant women, women who plan on becoming pregnant, or breastfeeding women

  • Current use or history of using any biologic medication

Study Design

Total Participants: 23
Study Start date:
September 01, 2010
Estimated Completion Date:
June 30, 2013

Study Description

A wide variety of topical vehicles are available for medications that treat scalp disorders. Proper vehicle selection is important when managing scalp conditions, such as seborrheic dermatitis, because the efficacy of these treatments depends largely on compliance and the amount of active ingredient delivered to the scalp. It is therefore important to prescribe vehicles that are easy to apply and cause the least amount of disruption to the patients' pre-existing hair care practices. One of the most common rate limiting hair care practices among different cultures is wash frequency. Literature shows African American women are more likely to wash their hair less than once weekly versus Caucasian women. We hypothesize certain vehicles, such as foam preparations which do not require hair washing, will be more efficacious in African American women with seborrheic dermatitis than shampoo preparations.

Connect with a study center

  • St. Louis University Department of Dermatology

    Saint Louis, Missouri 63104
    United States

    Site Not Available

  • St. Louis University Department of Dermatology

    St. Louis, Missouri 63104
    United States

    Site Not Available

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