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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Seborrheic Dermatitis of the Scalp in Populations Practicing Less Frequent Hair Washing: Ketoconazole 2% Foam Versus Ketoconazole 2% Shampoo

Brief 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.

Detailed Summary: 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.
Sponsor: St. Louis University

Current Primary Outcome: Total Dandruff Severity Score (TDSS) [ Time Frame: up to 8 weeks ]

The scalp will be divided into quadrants and for each quadrant the percent of involvement and degree of severity will be assessed. The percent of involvement will be measured on a scale of 0 to 4 in which a score of 0 means less than 10% involvement, and a score of 4, more than 76% involvement. Severity will be measured on a scale of 0 to 3 in which a score of 0 indicates normal skin, and a score of 3, marked erythema with thick confluent plates of yellowish white scales. The whole scalp score will then calculated by multiplying the total percent involvement score by the total severity score.


Original Primary Outcome: To determine if ketoconazole 2% foam is a more effective regimen for treatment of seborrheic dermatitis in patients practicing less than once weekly hair washing compared to ketoconazole 2% shampoo [ Time Frame: 4 weeks ]

The scalp will be divided into quadrants and for each quadrant the percent of involvement and degree of severity will be assessed.


Current Secondary Outcome:

  • Compliance [ Time Frame: up to 8 weeks ]
    Patient compliance will be evaluated by having patients keep a diary documenting the use of study drug. They will also be questioned about their medication usage at every visit. In addition, we will weigh the study drug at every visit.
  • Patient Satisfaction [ Time Frame: up to 8 weeks ]
    Patient satisfaction will be measured using a five point satisfaction scale.
  • Additional Improvement in the Total Dandruff Severity Score (TDSS) [ Time Frame: up to 4 weeks ]
    Shampoo subjects will be able to cross over into the foam group if their TDSS score does not improve by 60% at the end of the four week treatment period. These cross over subjects will remain in the study for an additional four weeks and apply foam in the same manner as subjects in the original foam group.


Original Secondary Outcome:

Information By: St. Louis University

Dates:
Date Received: September 14, 2010
Date Started: September 2010
Date Completion:
Last Updated: June 1, 2013
Last Verified: June 2013