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

Condition(s) targeted: Seborrheic Dermatitis

Intervention: ketoconazole 2% foam (Drug); ketoconazole 2% shampoo (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: St. Louis University

Official(s) and/or principal investigator(s):
Mary Guo, M.D., Study Director, Affiliation: St. Louis University Dermatology
Scott W Fosko, M.D., Study Chair, Affiliation: St. Louis University Dermatology
Jeaneen A Chappell, M.D., Principal Investigator, Affiliation: St. Louis University Dermatology

Overall contact:
Jeaneen A Chappell, MD, Phone: 314-256-3439, Email: jchappe1@slu.edu

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.

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Total Dandruff Severity Score (TDSS)

Secondary outcome:

Compliance

Patient Satisfaction

Additional Improvement in the Total Dandruff Severity Score (TDSS)

Detailed 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.

Minimum age: 18 Years. Maximum age: 89 Years. Gender(s): Female.

Criteria:

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

Jeaneen A Chappell, MD, Phone: 314-256-3439, Email: jchappe1@slu.edu

St. Louis University Department of Dermatology, St. Louis, Missouri 63104, United States; Recruiting
Jeaneen A Chappell, MD, Phone: 314-256-3439, Email: jchappe1@slu.edu
Rosemary King, PA, Phone: 314-256-3436, Email: kingrm@slu.edu
Jeaneen A Chappell, MD, Principal Investigator

Starting date: September 2010
Last updated: September 21, 2010