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

Seborrheic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01203189
• Other study ID #: seb derm 2010
• Status: Completed
• Phase: N/A
• First received: September 14, 2010
• Last updated: October 3, 2017
• Start date: September 2010
• Est. completion date: June 2013

Study information

• Verified date: October 2017
• Source: St. Louis University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Seborrheic
• Seborrheic Dermatitis

Intervention

Drug:
• ketoconazole 2% foam
Subjects in the Foam (F) group will apply ketoconazole 2% foam to the scalp twice daily for four weeks.
• ketoconazole 2% shampoo
Subjects in the Shampoo (S) group will wash their hair twice weekly for four weeks with ketoconazole 2% shampoo.

Locations

Country	Name	City	State
United States	St. Louis University Department of Dermatology	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
St. Louis University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Dandruff Severity Score (TDSS)	The scalp will be divided into quadrants and for each quadrant the percent of involvement and degree of severity will be assessed. The percent of involvement will be measured on a scale of 0 to 4 in which a score of 0 means less than 10% involvement, and a score of 4, more than 76% involvement. Severity will be measured on a scale of 0 to 3 in which a score of 0 indicates normal skin, and a score of 3, marked erythema with thick confluent plates of yellowish white scales. The whole scalp score will then calculated by multiplying the total percent involvement score by the total severity score.; Quadrant scalp score = percent involvement score x severity score Total scalp score = summation of all the quadrant scores TDSS value ranges from 0-48, with 0 equal to no scale, which is the best outcome, compared to 48, which is the most severe and worse outcome	up to 8 weeks
Secondary	Number of Participants Who Are Always Compliant.	Patient compliance will be evaluated by having patients keep a diary documenting the use of study drug. They will also be questioned about their medication usage at every visit. In addition, we will weigh the study drug at every visit.; a patient is classified as always indicates that they use their medicine as directed on their diary on every visit.	at end of each treatment period (4 weeks and 8 weeks)
Secondary	Number of Participants Who Are Very Satisfied	Patient satisfaction will be measured using a five point satisfaction scale.; very dissatisfied; dissatisfied; Neutral; satisfied; very satisfied.	data were collected at end of each treatment period (4 weeks and 8 weeks)