NCT00403559

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
113

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 21, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 23, 2006

Completed
6 months until next milestone

Study Start

First participant enrolled

May 7, 2007

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2009

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2009

Completed
13 years until next milestone

Results Posted

Study results publicly available

March 14, 2022

Completed
Last Updated

March 14, 2022

Status Verified

March 1, 2022

Enrollment Period

1.8 years

First QC Date

November 21, 2006

Results QC Date

November 22, 2013

Last Update Submit

March 11, 2022

Conditions

Seborrheic Dermatitis

Keywords

seborrheic dermatitis

Outcome Measures

Primary Outcomes (1)

  • 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).

    One week from Baseline

Secondary Outcomes (1)

  • Key Secondary Efficacy Will be the % of Patients With Facial Clearance

    4 weeks

Study Arms (2)

Elidel Cream (pimecrolimus)

EXPERIMENTAL

Elidel Cream to be applied twice daily for 4 weeks

Drug: Elidel

Ketoconazole Cream (Nizoral)

ACTIVE COMPARATOR

Ketoconazole Cream to be applied twice daily for 4 weeks

Drug: Ketoconazole Cream

Interventions

ElidelDRUG
Also known as: pimecrolimus
Elidel Cream (pimecrolimus)
Ketoconazole CreamDRUG
Also known as: Nizoral
Ketoconazole Cream (Nizoral)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dermatology Specialists

Louisville, Kentucky, 40202, United States

Location

MeSH Terms

Conditions

Dermatitis, Seborrheic

Interventions

pimecrolimusKetoconazole

Condition Hierarchy (Ancestors)

DermatitisSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland DiseasesSkin Diseases, EczematousSkin Diseases, Papulosquamous

Intervention Hierarchy (Ancestors)

PiperazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Limitations and Caveats

Trial limitations: patient usage diaries may not have been accurate. Greater improvement may have been seen in either arm with a longer trial.

Results Point of Contact

Title
Joseph F. Fowler, Jr., M.D.
Organization
Dermatology Specialists, PSC
fowlerjoe@msn.com
502-583-7546

Study Officials

  • Steven Kempers, MD

    Associated Skin Care Specialists

    PRINCIPAL INVESTIGATOR

  • Bernard Goffe, MD

    Dermatology Associates

    PRINCIPAL INVESTIGATOR

  • Debra Breneman, MD

    University of Cincinnati - Dermatology

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2006

First Posted

November 23, 2006

Study Start

May 7, 2007

Primary Completion

February 20, 2009

Study Completion

February 27, 2009

Last Updated

March 14, 2022

Results First Posted

March 14, 2022

Record last verified: 2022-03

Locations

US(1)