A 4 Week Study of Elidel (Pimecrolimus) for the Treatment of Seborrheic Dermatitis

Study Overview
=================
Brief Summary
-----------------
This is an exploratory study to determine effectiveness of Elidel for the treatment of seborrheic dermatitis

Detailed Description
-----------------
This is a 4 week study for patients 18 and older to compare the efficacy and safety of pimecrolimus cream 1% twice daily and ketaconazole cream 2 % twice daily for the treatment of seborrheic dermatitis.

Official Title
-----------------
A 4 Week Randomized Double-blind Parallel Group Active Comparator Controlled Study of Elidel (Pimecrolimus) for the Treatment of Seborrheic Dermatitis

Conditions
-----------------
Seborrheic Dermatitis

Intervention / Treatment
-----------------
* Drug: Elidel
* Drug: Ketoconazole Cream


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Elidel Cream (pimecrolimus)<br>Elidel Cream to be applied twice daily for 4 weeks | Drug: Elidel<br> <br> * Other names: pimecrolimus;|
| Active Comparator: Ketoconazole Cream (Nizoral)<br>Ketoconazole Cream to be applied twice daily for 4 weeks | Drug: Ketoconazole Cream<br> <br> * Other names: Nizoral;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Change of F-IGA From Baseline (BL) to wk 1 Will be the Primary Efficacy Variable. | 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). | One week from Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Key Secondary Efficacy Will be the % of Patients With Facial Clearance | Number of participants in each arm (Elidel vs Ketoconazole) who achieved total facial clearance. | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
seborrheic dermatitis