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
  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:


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
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 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

ClinicalTrials.gov processed this record on September 18, 2014