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

Saint Louis University (SLU)

Status: Completed

Conditions: Seborrheic Dermatitis

Treatments: Drug: ketoconazole 2% shampoo; Drug: ketoconazole 2% foam

Study type: Interventional

Funder types: Other

Identifiers

NCT01203189

seb derm 2010

Details and patient eligibility

About

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.

Full 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.

Enrollment: 23 patients

Sex: Female

Ages: 18 to 89 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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23 participants in 3 patient groups

Shampoo Group

Active Comparator group

Description:

Subjects in the S group will wash their hair twice weekly for four weeks with ketoconazole 2% shampoo.

Treatment:

Drug: ketoconazole 2% shampoo

Foam group

Active Comparator group

Description:

Subjects in the F group will apply ketoconazole 2% foam to the scalp twice daily for four weeks.

Treatment:

Drug: ketoconazole 2% foam

Cross Over Group

Active Comparator group

Description:

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.

Treatment:

Drug: ketoconazole 2% foam

Drug: ketoconazole 2% shampoo