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

NCT ID: NCT01203189

Last Updated: 2017-11-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2013-06-30

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.

Conditions

Seborrheic Dermatitis

Keywords

dandruff, flaky scalp

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Shampoo Group

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

Group Type: ACTIVE_COMPARATOR

ketoconazole 2% shampoo

Intervention Type: DRUG

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

Foam group

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

Group Type: ACTIVE_COMPARATOR

ketoconazole 2% foam

Intervention Type: DRUG

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

Cross Over Group

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.

Group Type: ACTIVE_COMPARATOR

ketoconazole 2% foam

Intervention Type: DRUG

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

ketoconazole 2% shampoo

Intervention Type: DRUG

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

Interventions

ketoconazole 2% foam

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

Intervention Type: DRUG

ketoconazole 2% shampoo

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

Intervention Type: DRUG

Other Intervention Names

Extina; Nizoral

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

St. Louis University

OTHER

Sponsor Role: lead

Responsible Party

Aibing M. Guo, MD

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Aibing M Guo, M.D.

Role: PRINCIPAL_INVESTIGATOR

St. Louis University Dermatology

Scott W Fosko, M.D.

Role: STUDY_CHAIR

St. Louis University Dermatology

Locations

St. Louis University Department of Dermatology

St Louis, Missouri, United States

Countries

United States

Other Identifiers

seb derm 2010

Identifier Type: -

Identifier Source: org_study_id