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A 4 Week Study of Elidel for the Treatment of Seborrheic Dermatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00403559
Recruitment Status : Completed
First Posted : November 23, 2006
Last Update Posted : April 1, 2009
Information provided by:
Dermatology Specialists Research

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

Condition or disease Intervention/treatment Phase
Seborrheic Dermatitis Drug: Elidel Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A 4 Week Randomized Double-Blind Parallel Group Active Comparator Controlled Study of Elidel for the Treatment of Seborrheic Dermatitis
Study Start Date : January 2007
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. The change of IGA from BL to wk 1 will be the primary efficacy variable

Secondary Outcome Measures :
  1. Key secondary efficacy will be the % of patients with facial clearance

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00403559

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United States, Kentucky
Dermatology Specialists
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
Dermatology Specialists Research
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Principal Investigator: Steven Kempers, MD Associated Skin Care Specialists
Principal Investigator: Bernard Goffe, MD Dermatology Associates
Principal Investigator: Debra Breneman, MD University of Cincinnati - Dermatology
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Responsible Party: Joseph F Fowler JR., M.D>, Dermatology Specialists Identifier: NCT00403559    
Other Study ID Numbers: CASM981CUS37
SAIRB # 06-4893
IND 75,225
First Posted: November 23, 2006    Key Record Dates
Last Update Posted: April 1, 2009
Last Verified: October 2007
Keywords provided by Dermatology Specialists Research:
seborrheic dermatitis
Additional relevant MeSH terms:
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Dermatitis, Seborrheic
Skin Diseases
Sebaceous Gland Diseases
Skin Diseases, Eczematous
Skin Diseases, Papulosquamous
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Dermatologic Agents
Immunosuppressive Agents
Immunologic Factors
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action