Clinical Trials Directory

Trials / Completed

CompletedNCT01203189

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
23 (actual)
Sponsor
St. Louis University · Academic / Other
Sex
Female
Age
18 Years – 89 Years
Healthy volunteers
Accepted

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

Interventions

TypeNameDescription
DRUGketoconazole 2% foamSubjects in the Foam (F) group will apply ketoconazole 2% foam to the scalp twice daily for four weeks.
DRUGketoconazole 2% shampooSubjects in the Shampoo (S) group will wash their hair twice weekly for four weeks with ketoconazole 2% shampoo.

Timeline

Start date
2010-09-01
Primary completion
2013-06-01
Completion
2013-06-01
First posted
2010-09-16
Last updated
2017-11-06
Results posted
2017-11-06

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01203189. Inclusion in this directory is not an endorsement.