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

NCT01203189 | Completed Results DMC

• 1 other identifier: seb derm 2010
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Seborrheic Dermatitis

Keywords

dandruff, flaky scalp

Outcome Measures

Primary Outcomes (1)

• 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

  up to 8 weeks

Secondary Outcomes (2)

• Number of Participants Who Are Always Compliant.

  at end of each treatment period (4 weeks and 8 weeks)

• Number of Participants Who Are Very Satisfied

  data were collected at end of each treatment period (4 weeks and 8 weeks)

Study Arms (3)

Shampoo Group

ACTIVE COMPARATOR

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

Drug: ketoconazole 2% shampoo

Foam group

ACTIVE COMPARATOR

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

Drug: ketoconazole 2% foam

Cross Over Group

ACTIVE COMPARATOR

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; Drug: ketoconazole 2% shampoo

Interventions

ketoconazole 2% foam DRUG

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

Also known as: Extina

Cross Over Group; Foam group

ketoconazole 2% shampoo DRUG

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

Also known as: Nizoral

Cross Over Group; Shampoo Group

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Louis University: lead

Study Sites (1)

St. Louis University Department of Dermatology

St Louis, Missouri, 63104, United States

Location

MeSH Terms

Conditions

Dermatitis, Seborrheic; Dandruff

Interventions

Ketoconazole

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases; Skin Diseases, Eczematous; Skin Diseases, Papulosquamous; Scalp Dermatoses

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

1. Small Sample Size. 2. Unable to control for wash frequency between the two groups, i.e. shampoo group vs foam group. 3. Study group was comprised of patients with moderate seborrheic dermatitis, results may vary in mild or severe cases.

Results Point of Contact

• Title: Aibing Mary Guo, M.D., Assistant Professor
• Organization: Saint Louis Univ Hospital

aguo@slu.edu

3142563430

Study Officials

• Aibing M Guo, M.D.

  St. Louis University Dermatology

  PRINCIPAL INVESTIGATOR

• Scott W Fosko, M.D.

  St. Louis University Dermatology

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 14, 2010
• First Posted: September 16, 2010
• Study Start: September 1, 2010
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: November 6, 2017
• Results First Posted: November 6, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)