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

Primary Purpose

Seborrheic Dermatitis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ketoconazole 2% foam
ketoconazole 2% shampoo
Sponsored by
St. Louis University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Seborrheic Dermatitis focused on measuring dandruff, flaky scalp

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • St. Louis University Department of Dermatology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Shampoo Group

Foam group

Cross Over Group

Arm Description

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

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.

Full Information

First Posted
September 14, 2010
Last Updated
October 3, 2017
Sponsor
St. Louis University
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1. Study Identification

Unique Protocol Identification Number
NCT01203189
Brief Title
Seborrheic Dermatitis: Ketoconazole 2% Foam Versus Ketoconazole 2% Shampoo
Official Title
Seborrheic Dermatitis of the Scalp in Populations Practicing Less Frequent Hair Washing: Ketoconazole 2% Foam Versus Ketoconazole 2% Shampoo
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Louis University

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seborrheic Dermatitis
Keywords
dandruff, flaky scalp

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Shampoo Group
Arm Type
Active Comparator
Arm Description
Subjects in the S group will wash their hair twice weekly for four weeks with ketoconazole 2% shampoo.
Arm Title
Foam group
Arm Type
Active Comparator
Arm Description
Subjects in the F group will apply ketoconazole 2% foam to the scalp twice daily for four weeks.
Arm Title
Cross Over Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
ketoconazole 2% foam
Other Intervention Name(s)
Extina
Intervention Description
Subjects in the Foam (F) group will apply ketoconazole 2% foam to the scalp twice daily for four weeks.
Intervention Type
Drug
Intervention Name(s)
ketoconazole 2% shampoo
Other Intervention Name(s)
Nizoral
Intervention Description
Subjects in the Shampoo (S) group will wash their hair twice weekly for four weeks with ketoconazole 2% shampoo.
Primary Outcome Measure Information:
Title
Total Dandruff Severity Score (TDSS)
Description
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
Time Frame
up to 8 weeks
Secondary Outcome Measure Information:
Title
Number of Participants Who Are Always Compliant.
Description
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.
Time Frame
at end of each treatment period (4 weeks and 8 weeks)
Title
Number of Participants Who Are Very Satisfied
Description
Patient satisfaction will be measured using a five point satisfaction scale. very dissatisfied dissatisfied Neutral satisfied very satisfied.
Time Frame
data were collected at end of each treatment period (4 weeks and 8 weeks)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aibing M Guo, M.D.
Organizational Affiliation
St. Louis University Dermatology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Scott W Fosko, M.D.
Organizational Affiliation
St. Louis University Dermatology
Official's Role
Study Chair
Facility Information:
Facility Name
St. Louis University Department of Dermatology
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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