A 4 Week Study of Elidel (Pimecrolimus) for the Treatment of Seborrheic Dermatitis

March 11, 2022 updated by: Dermatology Specialists Research

A 4 Week Randomized Double-blind Parallel Group Active Comparator Controlled Study of Elidel (Pimecrolimus) for the Treatment of Seborrheic Dermatitis

This is an exploratory study to determine effectiveness of Elidel for the treatment of seborrheic dermatitis

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

113

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Dermatology Specialists

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Elidel Cream (pimecrolimus)
Elidel Cream to be applied twice daily for 4 weeks
Drug: Elidel
Other Names:
  • pimecrolimus
Active Comparator: Ketoconazole Cream (Nizoral)
Ketoconazole Cream to be applied twice daily for 4 weeks
Drug: Ketoconazole Cream
Other Names:
  • Nizoral

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
One week from Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dermatology Specialists Research

Collaborators

Novartis

Investigators

  • Principal Investigator: Bernard Goffe, MD, Dermatology Associates
  • Principal Investigator: Steven Kempers, MD, Associated Skin Care Specialists
  • Principal Investigator: Debra Breneman, MD, University of Cincinnati - Dermatology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 7, 2007

Primary Completion (Actual)

February 20, 2009

Study Completion (Actual)

February 27, 2009

Study Registration Dates

First Submitted

November 21, 2006

First Submitted That Met QC Criteria

November 22, 2006

First Posted (Estimate)

November 23, 2006

Study Record Updates

Last Update Posted (Actual)

March 14, 2022

Last Update Submitted That Met QC Criteria

March 11, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CASM981CUS37
  • SAIRB # 06-4893 (Other Identifier: DematologySR)
  • IND 75,225 (Other Identifier: DematologySR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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