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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

113 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-07

Study Completion Date

2009-02-27

Brief Summary

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

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Detailed Description

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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.

Conditions

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Seborrheic Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Elidel Cream (pimecrolimus)

Elidel Cream to be applied twice daily for 4 weeks

Group Type EXPERIMENTAL

Elidel

Intervention Type DRUG

Ketoconazole Cream (Nizoral)

Ketoconazole Cream to be applied twice daily for 4 weeks

Group Type ACTIVE_COMPARATOR

Ketoconazole Cream

Intervention Type DRUG

Interventions

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Elidel

Intervention Type DRUG

Ketoconazole Cream

Intervention Type DRUG

Other Intervention Names

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pimecrolimus Nizoral

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes