Clinical trial NCT01203189: Seborrheic Dermatitis: Ketoconazole 2% Foam Versus Ketoconazole 2% Shampoo
Official title: Seborrheic Dermatitis of the Scalp in Populations Practicing Less Frequent Hair Washing: Ketoconazole 2% Foam Versus Ketoconazole 2% Shampoo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Seborrheic Dermatitis
Keywords: dandruff, flaky scalp
Lead sponsor: St. Louis University
Sponsor class: OTHER
First posted: 2010-09-16
Enrollment: 23
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 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.

Eligibility 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

Primary outcomes:
measure: Total Dandruff Severity Score (TDSS)
timeFrame: up to 8 weeks
Secondary outcomes:
measure: Number of Participants Who Are Always Compliant.
timeFrame: at end of each treatment period (4 weeks and 8 weeks)
measure: Number of Participants Who Are Very Satisfied
timeFrame: data were collected at end of each treatment period (4 weeks and 8 weeks)
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: St. Louis University Department of Dermatology
state: Missouri
Study officials:
affiliation: St. Louis University Dermatology
name: Aibing M Guo, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Louis University Dermatology
name: Scott W Fosko, M.D.
role: STUDY_CHAIR
References: