Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00403559 | A 4 Week Study of Elidel (Pimecrolimus) for the Treatment of Seborrheic Dermatitis | PHASE2 | COMPLETED | 113 | — | — | May 7, 2007 | Feb 27, 2009 | Mar 14, 2022 | 1 | United States |
F-IGA is defined as Facial Investigator's Global Assessment, which incorporates assessments of the severity of facial seborrheic dermatitis. Scoring is 0 to 3, 0 describing a better outcome with progressively worsening up to 3 representing a worse outcome (whole number only). 0 = Clear; 1 = Mild; 2 = Moderate and 3 = Severe. Scoring is based upon morphologic description of signs of erythema (0 =none, 1= faint, 2 =dull, 3 =deep/dark red) and scaling (0 = none, 1 = minute, powdery scale, 2 = thin flakes of scale, 3 = scales covering most of the involved areas).
| Arm | Type | Description |
|---|---|---|
| Elidel Cream (pimecrolimus) | EXPERIMENTAL | Elidel Cream to be applied twice daily for 4 weeks |
| Ketoconazole Cream (Nizoral) | ACTIVE_COMPARATOR | Ketoconazole Cream to be applied twice daily for 4 weeks |
| Name | Type | Description |
|---|---|---|
| Elidel | DRUG | - |
| Ketoconazole Cream | DRUG | - |
Inclusion Criteria: * Must be 18 or older and sign written informed consent. * Must be wiling and able to comply with protocol. * Must have active seborrheic dermatitis of the face. Exclusion Criteria: * No history of overt bacterial, viral or fungal infection of the head/neck. * No history or pr...