We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01203189
First Posted: September 16, 2010
Last Update Posted: November 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Aibing M. Guo, MD, St. Louis University
  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
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

Resource links provided by NLM:


Further study details as provided by Aibing M. Guo, MD, St. Louis University:

Primary Outcome Measures:
  • 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:
  • 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.


  • 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.


Enrollment: 23
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 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

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 89 Years   (Adult, Senior)
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01203189


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     History of Changes
Other Study ID Numbers: seb derm 2010
First Submitted: September 14, 2010
First Posted: September 16, 2010
Results First Submitted: March 16, 2016
Results First Posted: November 2, 2017
Last Update Posted: November 2, 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