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

Dermatology Specialists Research

Status and phase: Completed; Phase 2

Conditions: Seborrheic Dermatitis

Treatments: Drug: Ketoconazole Cream; Drug: Elidel

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00403559

CASM981CUS37

IND 75,225

SAIRB # 06-4893

Details and patient eligibility

About

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

Full 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.

Enrollment: 113 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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113 participants in 2 patient groups

Elidel Cream (pimecrolimus)

Experimental group

Description:

Elidel Cream to be applied twice daily for 4 weeks

Treatment:

Drug: Elidel

Ketoconazole Cream (Nizoral)

Active Comparator group

Description:

Ketoconazole Cream to be applied twice daily for 4 weeks

Treatment:

Drug: Ketoconazole Cream