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

• ClinicalTrials.gov Identifier: NCT01203189
• Recruitment Status: Completed
• First Posted: September 16, 2010
• Results First Posted: November 6, 2017
• Last Update Posted: November 6, 2017
• Sponsor: St. Louis University
• Information provided by (Responsible Party): Aibing M. Guo, MD, St. Louis University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Seborrheic Dermatitis	Drug: ketoconazole 2% foam; Drug: ketoconazole 2% shampoo	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 23 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Seborrheic Dermatitis of the Scalp in Populations Practicing Less Frequent Hair Washing: Ketoconazole 2% Foam Versus Ketoconazole 2% Shampoo
• Study Start Date: September 2010
• Actual Primary Completion Date: June 2013
• Actual Study Completion Date: June 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Total Dandruff Severity Score (TDSS) [ Time Frame: up to 8 weeks ]

   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

Secondary Outcome Measures :

1. Number of Participants Who Are Always Compliant. [ Time Frame: at end of each treatment period (4 weeks and 8 weeks) ]

   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.

2. Number of Participants Who Are Very Satisfied [ Time Frame: data were collected at end of each treatment period (4 weeks and 8 weeks) ]

   Patient satisfaction will be measured using a five point satisfaction scale.

   1. very dissatisfied
   2. dissatisfied
   3. Neutral
   4. satisfied
   5. very satisfied.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 89 Years (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

United States, Missouri

St. Louis University Department of Dermatology

Saint Louis, Missouri, United States, 63104

Sponsors and Collaborators

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

More Information

• Responsible Party: Aibing M. Guo, MD, Assistant Professor, St. Louis University
• ClinicalTrials.gov Identifier: NCT01203189
• Other Study ID Numbers: seb derm 2010
• First Posted: September 16, 2010
• Results First Posted: November 6, 2017
• Last Update Posted: November 6, 2017
• Last Verified: October 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Aibing M. Guo, MD, St. Louis University:

dandruff, flaky scalp

Additional relevant MeSH terms:

Dermatitis; Dermatitis, Seborrheic; Skin Diseases; Sebaceous Gland Diseases; Skin Diseases, Eczematous; Skin Diseases, Papulosquamous; Ketoconazole; Antifungal Agents; Anti-Infective Agents; 14-alpha Demethylase Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Steroid Synthesis Inhibitors; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Cytochrome P-450 CYP3A Inhibitors