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A 4 Week Study of Elidel (Pimecrolimus) 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.
 
ClinicalTrials.gov Identifier: NCT00403559
Recruitment Status : Completed
First Posted : November 23, 2006
Results First Posted : March 14, 2022
Last Update Posted : March 14, 2022
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
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 Drug: Ketoconazole Cream Phase 2

Detailed Description:
This is a 4 week study for patients 18 and older to 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)
Actual Enrollment : 113 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 4 Week Randomized Double-blind Parallel Group Active Comparator Controlled Study of Elidel (Pimecrolimus) for the Treatment of Seborrheic Dermatitis
Actual Study Start Date : May 7, 2007
Actual Primary Completion Date : February 20, 2009
Actual Study Completion Date : February 27, 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Elidel Cream (pimecrolimus)
Elidel Cream to be applied twice daily for 4 weeks
Drug: Elidel
Other Name: pimecrolimus

Active Comparator: Ketoconazole Cream (Nizoral)
Ketoconazole Cream to be applied twice daily for 4 weeks
Drug: Ketoconazole Cream
Other Name: Nizoral




Primary Outcome Measures :
  1. The Change of F-IGA From Baseline (BL) to wk 1 Will be the Primary Efficacy Variable. [ Time Frame: One week from Baseline ]
    F-IGA is defined as Facial Investigator's Global Assessment, which incorporates assessments of the severity of facial seborrheic dermatitis. Scoring is 0 to 3, 0 describing a better outcome with progressively worsening up to 3 representing a worse outcome (whole number only). 0 = Clear; 1 = Mild; 2 = Moderate and 3 = Severe. Scoring is based upon morphologic description of signs of erythema (0 =none, 1= faint, 2 =dull, 3 =deep/dark red) and scaling (0 = none, 1 = minute, powdery scale, 2 = thin flakes of scale, 3 = scales covering most of the involved areas).


Secondary Outcome Measures :
  1. Key Secondary Efficacy Will be the % of Patients With Facial Clearance [ Time Frame: 4 weeks ]
    Number of participants in each arm (Elidel vs Ketoconazole) who achieved total 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
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United States, Kentucky
Dermatology Specialists
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
Dermatology Specialists Research
Novartis
Investigators
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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: Dermatology Specialists Research
ClinicalTrials.gov Identifier: NCT00403559    
Other Study ID Numbers: CASM981CUS37
SAIRB # 06-4893 ( Other Identifier: DematologySR )
IND 75,225 ( Other Identifier: DematologySR )
First Posted: November 23, 2006    Key Record Dates
Results First Posted: March 14, 2022
Last Update Posted: March 14, 2022
Last Verified: March 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dermatology Specialists Research:
seborrheic dermatitis
Additional relevant MeSH terms:
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Dermatitis
Dermatitis, Seborrheic
Skin Diseases
Sebaceous Gland Diseases
Skin Diseases, Eczematous
Skin Diseases, Papulosquamous
Ketoconazole
Pimecrolimus
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Dermatologic Agents
Immunosuppressive Agents
Immunologic Factors
Calcineurin Inhibitors