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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jeaneen Chappell, St. Louis University
ClinicalTrials.gov Identifier:
NCT01203189
First received: September 14, 2010
Last updated: June 1, 2013
Last verified: June 2013
  Purpose

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 Intervention
Seborrheic Dermatitis
Drug: ketoconazole 2% foam
Drug: ketoconazole 2% shampoo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by St. Louis University:

Primary Outcome Measures:
  • Total Dandruff Severity Score (TDSS) [ Time Frame: up to 8 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Compliance [ Time Frame: up to 8 weeks ] [ Designated as safety issue: No ]
    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.

  • Patient Satisfaction [ Time Frame: up to 8 weeks ] [ Designated as safety issue: No ]
    Patient satisfaction will be measured using a five point satisfaction scale.

  • Additional Improvement in the Total Dandruff Severity Score (TDSS) [ Time Frame: up to 4 weeks ] [ Designated as safety issue: No ]
    Shampoo subjects will be able to cross over into the foam group if their TDSS score does not improve by 60% at the end of the four week treatment period. These cross over subjects will remain in the study for an additional four weeks and apply foam in the same manner as subjects in the original foam group.


Enrollment: 32
Study Start Date: September 2010
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 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 F group will apply ketoconazole 2% foam to the scalp twice daily for four weeks.
Other Name: Extina
Active Comparator: Cross Over Group
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. These cross over subjects will remain in the study for an additional four weeks and apply foam in the same manner as subjects in the original Foam group.
Drug: ketoconazole 2% foam
Subjects in the F group will apply ketoconazole 2% foam to the scalp twice daily for four weeks.
Other Name: Extina

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.

  Eligibility

Ages Eligible for Study:   18 Years to 89 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01203189

Locations
United States, Missouri
St. Louis University Department of Dermatology
St. Louis, Missouri, United States, 63104
Sponsors and Collaborators
St. Louis University
Investigators
Study Director: Mary Guo, M.D. St. Louis University Dermatology
Study Chair: Scott W Fosko, M.D. St. Louis University Dermatology
Principal Investigator: Jeaneen A Chappell, M.D. St. Louis University Dermatology
  More Information

No publications provided

Responsible Party: Jeaneen Chappell, Dermatology Resident, St. Louis University
ClinicalTrials.gov Identifier: NCT01203189     History of Changes
Other Study ID Numbers: seb derm 2010
Study First Received: September 14, 2010
Last Updated: June 1, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by St. Louis University:
dandruff, flaky scalp

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Seborrheic
Sebaceous Gland Diseases
Skin Diseases
Skin Diseases, Eczematous
Skin Diseases, Papulosquamous
Ketoconazole
14-alpha Demethylase Inhibitors
Anti-Infective Agents
Antifungal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014