Phase 2
Completed N=112
A 4 Week Study of Elidel (Pimecrolimus) for the Treatment of Seborrheic Dermatitis
Seborrheic Dermatitis
Source: ClinicalTrials.gov NCT00403559 ↗
Enrolled (actual)
112
Serious AEs
0.0%
Results posted
Mar 2022
Primary outcomePrimary: The Change of F-IGA From Baseline (BL) to wk 1 Will be the Primary Efficacy Variable. — -0.9; -0.6 units on a scale — p=.009
Summary
This is an exploratory study to determine effectiveness of Elidel for the treatment of seborrheic dermatitis
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Change of F-IGA From Baseline (BL) to wk 1 Will be the Primary Efficacy Variable. |
-0.9; -0.6 | .009 sig |
| SECONDARY Key Secondary Efficacy Will be the % of Patients With Facial Clearance |
56; 56 | — |
Eligibility Criteria
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 presence of compromising dermatosis elsewhere on the skin
- No Parkinson's disease, HIV, infections or disorders of the central nervous system
- No actinically damaged skin
Data sourced from ClinicalTrials.gov (NCT00403559). 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.