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Completed

NCT Number: NCT01203189

Seborrheic Dermatitis: 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.

Completed

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Key information

Age range

18 year–89 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

St. Louis University Department of Dermatology

St Louis, Missouri, 63104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ketoconazole 2% Foam

Drug

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

Other names: Extina

ketoconazole 2% shampoo

Drug

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

Other names: Nizoral

Primary outcomes

  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 outcomes

  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.

    • very dissatisfied
    • dissatisfied
    • Neutral
    • satisfied
    • very satisfied.

Sponsors and collaborators

Lead sponsor

St. Louis University

Other

Registry information

Official study title

Seborrheic Dermatitis of the Scalp in Populations Practicing Less Frequent Hair Washing: Ketoconazole 2% Foam Versus Ketoconazole 2% Shampoo

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Sep 16, 2010
Registry last updated
Nov 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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