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

This study has been completed.
Sponsor:
Collaborator:
Novartis
Information provided by:
Dermatology Specialists Research
ClinicalTrials.gov Identifier:
NCT00403559
First received: November 21, 2006
Last updated: March 31, 2009
Last verified: October 2007
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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:

U.S. FDA Resources

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: November 21, 2006
Last Updated: March 31, 2009
Health Authority: United States: Food and Drug Administration

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
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Dermatologic Agents
Immunosuppressive Agents
Immunologic Factors
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 23, 2013