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

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ClinicalTrials.gov Identifier: NCT00403559
Recruitment Status : Completed
First Posted : November 23, 2006
Last Update Posted : April 1, 2009
Sponsor:
Collaborator:
Novartis
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.

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

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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

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

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 ClinicalTrials.gov identifier (NCT number): NCT00403559


Locations
United States, Kentucky
Dermatology Specialists
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
Dermatology Specialists Research
Novartis
Investigators
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

Responsible Party: Joseph F Fowler JR., M.D>, Dermatology Specialists
ClinicalTrials.gov Identifier: NCT00403559     History of Changes
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:
Dermatitis
Dermatitis, Seborrheic
Skin Diseases
Sebaceous Gland Diseases
Skin Diseases, Eczematous
Skin Diseases, Papulosquamous
Pimecrolimus
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
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