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

Dermatology Specialists Research113 enrolled

Overview

This is an exploratory study to determine effectiveness of Elidel for the treatment of seborrheic dermatitis

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

113

Conditions

Seborrheic Dermatitis

Interventions

ElidelDRUG

Ketoconazole CreamDRUG

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Dermatology Specialists

Louisville, Kentucky, United States

Outcomes

Primary Outcomes

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).

Time frame: One week from Baseline

Secondary Outcomes

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.

Time frame: 4 weeks

Data from ClinicalTrials.gov

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