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

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.

Study Overview

• Status: Completed
• Conditions: Seborrheic Dermatitis
• Intervention / Treatment: Drug: ketoconazole 2% shampoo; Drug: ketoconazole 2% foam

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.

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63104
      • St. Louis University Department of Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Shampoo Group; Subjects in the S group will wash their hair twice weekly for four weeks with ketoconazole 2% shampoo.	Drug: ketoconazole 2% shampoo; Subjects in the Shampoo (S) group will wash their hair twice weekly for four weeks with ketoconazole 2% shampoo.; Other Names: Nizoral
Active Comparator: Foam group; Subjects in the F group will apply ketoconazole 2% foam to the scalp twice daily for four weeks.	Drug: ketoconazole 2% foam; Subjects in the Foam (F) group will apply ketoconazole 2% foam to the scalp twice daily for four weeks.; Other Names: Extina
Active Comparator: 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.	Drug: ketoconazole 2% shampoo; Subjects in the Shampoo (S) group will wash their hair twice weekly for four weeks with ketoconazole 2% shampoo.; Other Names: Nizoral; Drug: ketoconazole 2% foam; Subjects in the Foam (F) group will apply ketoconazole 2% foam to the scalp twice daily for four weeks.; Other Names: Extina

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)

Collaborators and Investigators

• Sponsor: St. Louis University
• Investigators: Principal Investigator: Aibing M Guo, M.D., St. Louis University Dermatology; Study Chair: Scott W Fosko, M.D., St. Louis University Dermatology

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: September 14, 2010
• First Submitted That Met QC Criteria: September 14, 2010
• First Posted (Estimate): September 16, 2010

Study Record Updates

• Last Update Posted (Actual): November 6, 2017
• Last Update Submitted That Met QC Criteria: October 3, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: dandruff, flaky scalp
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Skin Diseases, Eczematous; Sebaceous Gland Diseases; Dermatitis; Dermatitis, Seborrheic; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Hormone Antagonists; Antifungal Agents; Steroid Synthesis Inhibitors; 14-alpha Demethylase Inhibitors; Ketoconazole
• Other Study ID Numbers: seb derm 2010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No