Seborrheic Dermatitis Clinical Trial
Official title:
A 4 Week Randomized Double-blind Parallel Group Active Comparator Controlled Study of Elidel (Pimecrolimus) for the Treatment of Seborrheic Dermatitis
Verified date | March 2022 |
Source | Dermatology Specialists Research |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is an exploratory study to determine effectiveness of Elidel for the treatment of seborrheic dermatitis
Status | Completed |
Enrollment | 113 |
Est. completion date | February 27, 2009 |
Est. primary completion date | February 20, 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Dermatology Specialists | Louisville | Kentucky |
Lead Sponsor | Collaborator |
---|---|
Dermatology Specialists Research | Novartis |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 |
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