A 4 Week Study of Elidel for the Treatment of Seborrheic Dermatitis - Full Text View

A 4 Week Study of Elidel for the Treatment of Seborrheic Dermatitis

This study is currently recruiting participants.
Verified by Dermatology Specialists Research, October 2007

Sponsors and Collaborators:	Dermatology Specialists Research Novartis
Information provided by:	Dermatology Specialists Research
ClinicalTrials.gov Identifier:	NCT00403559

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 II

ChemIDplus related topics:

Pimecrolimus

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	A 4 Week Randomized Double-Blind Parallel Group Active Comparator Controlled Study of Elidel for the Treatment of Seborrheic Dermatitis

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

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00403559

Contacts


Contact: Joseph F Fowler, MD	502-583-7546	dermresearchmlh@msn.com

Contact: Misty l Humphress, RN	502-583-7546	dermresearchmlh@msn.com

Locations


United States, Kentucky
	Dermatology Specialists	Recruiting
	Louisville, Kentucky, United States, 40202
	Contact: Joseph F Fowler, M.D. 502-583-7546 ext 6 dermresearchmlh@msn.com
	Contact: Misty L Humphress, RN, BSN 502-583-7546 ext 6 dermresearchmlh@msn.com
	Principal Investigator: Joseph F Fowler, M.D.

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

Study ID Numbers:	CASM981CUS37, SAIRB # 06-4893, IND 75,225
First Received:	November 21, 2006
Last Updated:	October 30, 2007
ClinicalTrials.gov Identifier:	NCT00403559
Health Authority:	United States: Food and Drug Administration

Keywords provided by Dermatology Specialists Research:

seborrheic dermatitis

Study placed in the following topic categories:

Dermatitis, Seborrheic

Skin Diseases

Skin Diseases, Eczematous

Pimecrolimus

Sebaceous Gland Diseases

Skin Diseases, Papulosquamous

Dermatitis

Additional relevant MeSH terms:

Anti-Inflammatory Agents

Immunologic Factors

Physiological Effects of Drugs

Immunosuppressive Agents

Pharmacologic Actions

Analgesics, Non-Narcotic

Sensory System Agents

Therapeutic Uses

Anti-Inflammatory Agents, Non-Steroidal

Analgesics

Peripheral Nervous System Agents

Antirheumatic Agents

Central Nervous System Agents

Dermatologic Agents

ClinicalTrials.gov processed this record on October 03, 2008