N/A
Completed N=23
Seborrheic Dermatitis: Ketoconazole 2% Foam Versus Ketoconazole 2% Shampoo
Seborrheic Dermatitis
Source: ClinicalTrials.gov NCT01203189 ↗
Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Nov 2017
Primary outcomePrimary: Total Dandruff Severity Score (TDSS) — 28.6; 29.3; 26.7; 2.1 units on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Dandruff Severity Score (TDSS) |
28.6; 29.3; 26.7; 2.1; 5.6; 33.7 | — |
| SECONDARY Number of Participants Who Are Always Compliant. |
7; 3; 1; 0 | — |
| SECONDARY Number of Participants Who Are Very Satisfied |
5; 8; 0; 0 | — |
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
Data sourced from ClinicalTrials.gov (NCT01203189). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.