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

This study has been completed.
Information provided by:
Dermatology Specialists Research Identifier:
First received: November 21, 2006
Last updated: March 31, 2009
Last verified: October 2007
This is an exploratory study to determine effectiveness of Elidel for the treatment of seborrheic dermatitis

Condition Intervention Phase
Seborrheic Dermatitis Drug: Elidel Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Dermatology Specialists Research:

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

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

Estimated Enrollment: 110
Study Start Date: January 2007
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00403559

United States, Kentucky
Dermatology Specialists
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
Dermatology Specialists Research
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
  More Information

Responsible Party: Joseph F Fowler JR., M.D>, Dermatology Specialists Identifier: NCT00403559     History of Changes
Other Study ID Numbers: CASM981CUS37
SAIRB # 06-4893
IND 75,225
Study First Received: November 21, 2006
Last Updated: March 31, 2009

Keywords provided by Dermatology Specialists Research:
seborrheic dermatitis

Additional relevant MeSH terms:
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 processed this record on September 21, 2017