Back to resultsA 4 Week Study of Elidel (Pimecrolimus) for the Treatment of Seborrheic Dermatitis
Primary Purpose
Seborrheic Dermatitis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Elidel
Ketoconazole Cream
Sponsored by
About this trial
This is an interventional treatment trial for Seborrheic Dermatitis focused on measuring seborrheic dermatitis
Eligibility 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
Sites / Locations
- Dermatology Specialists
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Elidel Cream (pimecrolimus)
Ketoconazole Cream (Nizoral)
Arm Description
Elidel Cream to be applied twice daily for 4 weeks
Ketoconazole Cream to be applied twice daily for 4 weeks
Outcomes
Primary Outcome Measures
The Change of F-IGA From Baseline (BL) to wk 1 Will be the Primary Efficacy Variable.
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
Key Secondary Efficacy Will be the % of Patients With Facial Clearance
Number of participants in each arm (Elidel vs Ketoconazole) who achieved total facial clearance.
Full Information
NCT ID
NCT00403559
First Posted
November 21, 2006
Last Updated
March 11, 2022
Sponsor
Dermatology Specialists Research
Collaborators
Novartis
1. Study Identification
Unique Protocol Identification Number
NCT00403559
Brief Title
A 4 Week Study of Elidel (Pimecrolimus) for the Treatment of Seborrheic Dermatitis
Official Title
A 4 Week Randomized Double-blind Parallel Group Active Comparator Controlled Study of Elidel (Pimecrolimus) for the Treatment of Seborrheic Dermatitis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
May 7, 2007 (Actual)
Primary Completion Date
February 20, 2009 (Actual)
Study Completion Date
February 27, 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dermatology Specialists Research
Collaborators
Novartis
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This is an exploratory study to determine effectiveness of Elidel for the treatment of seborrheic dermatitis
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seborrheic Dermatitis
Keywords
seborrheic dermatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
113 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Elidel Cream (pimecrolimus)
Arm Type
Experimental
Arm Description
Elidel Cream to be applied twice daily for 4 weeks
Arm Title
Ketoconazole Cream (Nizoral)
Arm Type
Active Comparator
Arm Description
Ketoconazole Cream to be applied twice daily for 4 weeks
Intervention Type
Drug
Intervention Name(s)
Elidel
Other Intervention Name(s)
pimecrolimus
Intervention Type
Drug
Intervention Name(s)
Ketoconazole Cream
Other Intervention Name(s)
Nizoral
Primary Outcome Measure Information:
Title
The Change of F-IGA From Baseline (BL) to wk 1 Will be the Primary Efficacy Variable.
Description
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).
Time Frame
One week from Baseline
Secondary Outcome Measure Information:
Title
Key Secondary Efficacy Will be the % of Patients With Facial Clearance
Description
Number of participants in each arm (Elidel vs Ketoconazole) who achieved total facial clearance.
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Kempers, MD
Organizational Affiliation
Associated Skin Care Specialists
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bernard Goffe, MD
Organizational Affiliation
Dermatology Associates
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Debra Breneman, MD
Organizational Affiliation
University of Cincinnati - Dermatology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dermatology Specialists
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A 4 Week Study of Elidel (Pimecrolimus) for the Treatment of Seborrheic Dermatitis
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