Phase 2
N=112
A 4 Week Study of Elidel (Pimecrolimus) for the Treatment of Seborrheic Dermatitis
Seborrheic Dermatitis
Bottom Line
View on ClinicalTrials.gov: NCT00403559 ↗Enrolled (actual)
112
Serious AEs
0.0%
Results posted
Mar 2022
Primary outcome: Primary: 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
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Elidel (Drug); Ketoconazole Cream (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Dermatology Specialists Research
- Primary completion
- Feb 2009
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 | — |
Summary
This is an exploratory study to determine effectiveness of Elidel for the treatment of seborrheic dermatitis
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.