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

Study Overview
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Brief Summary
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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 Description
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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.

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

Conditions
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Seborrheic Dermatitis

Intervention / Treatment
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* Drug: ketoconazole 2% foam
* Drug: ketoconazole 2% shampoo


Participation Criteria
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Eligibility Criteria
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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 Criteria: Age below 18 years or above 89 years Medical history of psoriasis, diabetes mellitus, immunosuppression, neurologic disorders, 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 shampoo including sulfur The use of any topical medications including over the counter products indicated for the 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Shampoo Group<br>Subjects in the S group will wash their hair twice weekly for four weeks with ketoconazole 2% shampoo. | Drug: ketoconazole 2% shampoo<br>* Subjects in the Shampoo (S) group will wash their hair twice weekly for four weeks with ketoconazole 2% shampoo.<br>* Other names: Nizoral;|
| Active Comparator: Foam group<br>Subjects in the F group will apply ketoconazole 2% foam to the scalp twice daily for four weeks. | Drug: ketoconazole 2% foam<br>* Subjects in the Foam (F) group will apply ketoconazole 2% foam to the scalp twice daily for four weeks.<br>* Other names: Extina;|
| Active Comparator: Cross Over Group<br>apply ketoconazole 2% foam to scalp twice daily for four weeks. Subjects in the Shampoo group will be able to cross over into the Foam group if the TDSS score does not improve by 60% at the end of the four week treatment period using shampoo. | Drug: ketoconazole 2% foam<br>* Subjects in the Foam (F) group will apply ketoconazole 2% foam to the scalp twice daily for four weeks.<br>* Other names: Extina;Drug: ketoconazole 2% shampoo<br>* Subjects in the Shampoo (S) group will wash their hair twice weekly for four weeks with ketoconazole 2% shampoo.<br>* Other names: Nizoral;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Dandruff Severity Score (TDSS) | 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. Quadrant scalp score = percent involvement score x severity score Total scalp score = summation of all the quadrant scores TDSS value ranges from 0-48, with 0 equal to no scale, which is the best outcome, compared to 48, which is the most severe and worse outcome | up to 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Are Always Compliant. | 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. a patient is classified as always indicates that they use their medicine as directed on their diary on every visit. | at end of each treatment period (4 weeks and 8 weeks) | 
| Number of Participants Who Are Very Satisfied | Patient satisfaction will be measured using a five point satisfaction scale. very dissatisfied dissatisfied Neutral satisfied very satisfied. | data were collected at end of each treatment period (4 weeks and 8 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dandruff, flaky scalp