Long Term Study of Extina in Patients With Seborrheic Dermatitis

Condition(s) targeted: Seborrheic Dermatitis

Intervention: Extina (ketoconazole) foam, 2% (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Stiefel Laboratories

Official(s) and/or principal investigator(s):
David A Angulo, MD, Study Director, Affiliation: Stiefel Labortories, Inc., Sr. Director Global Clinical Research

Open-label, multicenter, single-group study to assess the long-term safety of twice daily treatment with Extina (ketoconazole) Foam, 2% in subjects with seborrheic dermatitis.

Official title: A Phase 4, Open-Label Study to Assess the Long-Term Safety of Extina (Ketoconazole) Foam, 2% in the Treatment of Seborrheic Dermatitis.

Study design: Treatment, Open Label, Single Group Assignment, Safety Study

Primary outcome: To assess the long-term safety of Extina (ketoconazole) Foam, 2% in the treatment of seborrheic dermatitis.

Detailed description: The study subjects must have seborrheic dermatitis and will apply Extina (ketoconazole) Foam, 2% topically twice a day (morning and evening) to all seborrheic dermatitis lesions on the face, scalp, ears, neck, and chest until resolution throughout the 12 month study period.

Study visits will occur at baseline (day 1) and at weeks 4, 8, 16, 26, 39, and 52 (or early withdrawal). Safety will be assessed by evaluation of adverse events (AEs), vital signs, physical examinations, withdrawals from the study, and results of safety laboratory tests.

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Capable of understanding and willing to provide signed and dated written voluntary

informed consent before any protocol specific procedures are performed. For subjects between the ages of 12 and 17 years, a parent or legal guardian must be capable of understanding and willing to sign informed consent and subject must be capable of understanding and willing to sign an adolescent assent.

- Male or female subjects 12 years of age or older.

- Able to complete the study and to comply with study instructions.

- Female subjects of childbearing potential must have a negative pregnancy test.

Sexually active women of childbearing potential participating in the study must agree to use a medically acceptable form of contraception .

- Seborrheic dermatitis on the face, scalp, ears, neck, or chest

Exclusion Criteria:

- Use of systemic antifungal agents, corticosteroids or other immunosuppressive

therapies, or systemic retinoids within 4 weeks prior to the baseline visit.

- Use of topical antifungal therapy, corticosteroid therapy, or calcineurin inhibitors

to the face, scalp, ears, neck, or chest within 2 weeks prior to the baseline visit.

- Use of any investigational drugs within 4 weeks prior to the baseline visit, or

subjects scheduled to receive an investigative drug other than the study product during the period of the study.

- History of known or suspected intolerance to any of the ingredients of the study

product.

- Female subjects who are pregnant, trying to become pregnant or lactating.

- Any clinically relevant abnormal vital signs or findings on the physical examination

or clinically significant condition which would, in the opinion of the investigator, compromise the subject's participation in the study.

- Considered unable or unlikely to attend the necessary visits.

- Currently using any medication, which in the opinion of the investigator may affect

the evaluation of the study product or place the subjects at undue risk.

University of Alabama at Birmingham, Birmingham, Alabama 35233, United States; Recruiting
Laura Bradford, Phone: 205-502-9960
Boni Elewski, MD, Principal Investigator

Guy Webster, Hockessin, Delaware 19707, United States; Recruiting
Lori Grimes, Phone: 302-234-9305
Guy Webster, MD, Principal Investigator

The Dermatology and Aesthetic Center, Boca Raton, Florida 33486, United States; Recruiting
Mariana Pinzon-Plazas, Phone: 571-750-0544
Marta Rendon, MD, Principal Investigator

Dermatology Associates & Research, Coral Gables, Florida 33134, United States; Recruiting
Luz Marin, Phone: 305-567-1930, Ext: 14
David Rodriquez, MD, Principal Investigator

Spencer Dermatology & Skin Surgery, St. Petersburg, Florida 33716, United States; Recruiting
Lynn Allen, Phone: 727-572-1333
James Spencer, MD, Principal Investigator

The Weiss Skin Institute, Boca Raton, Florida 33428, United States; Recruiting
Denise Howard, RN, Phone: 561-372-7546
Stefan Weiss, MD, Principal Investigator

Tulane University, New Orleans, Louisiana 70112, United States; Recruiting
Edward W. Coleman, Phone: 504-988-5135
Erin Boh, MD, PhD, Principal Investigator

Massachusettes General Hospital, Boston, Massachusetts 02114, United States; Recruiting
Xinaida Lima, Phone: 617-726-1660
Alexa Kimball, MD, Principal Investigator

Henry Ford Medical Center, Detroit, Michigan 48202, United States; Recruiting
Karen McKenzie, Phone: 313-916-8847
Linda SteinGold, MD, Principal Investigator

Dermatology Consulting Services, High Point, North Carolina 27262, United States; Recruiting
Tina Hatch, Phone: 336-841-2040
Zoe Draelos, MD, Principal Investigator

Wake Forest University Health Sciences, Winston Salem, North Carolina 27157, United States; Recruiting
Robin Inabinet, Phone: 336-716-3775
Steve Feldman, MD, Principal Investigator

Oregon Dermatology and Research Center, Portland, Oregon 97210, United States; Recruiting
Bernie Severson, CCRC, Phone: 503-226-3376
Phoebe Rich, MD, Principal Investigator

Dermatology Treatment & Research Center, Dallas, Texas 75230, United States; Recruiting
Nicole Brown, Phone: 972-661-2729
William Abramovits, MD, Principal Investigator

Baylor Research Institute, Dallas, Texas 75246, United States; Recruiting
Natasha Whitaker, BS, Phone: 214-820-6185
Alan Menter, MD, Principal Investigator

Arlington Center for Dermatology, Arlington, Texas 76011, United States; Recruiting
Alicia Soulivong, Phone: 817-795-7546
Angela Moore, MD, Principal Investigator

University of Texas Southwestern Medical Center, Dallas, Texas 75930, United States; Recruiting
Christina Carrigan, Phone: 214-645-8968
Amit Pandya, MD, Principal Investigator

Virginia Clinical Research, Inc., Norfolk, Virginia 23507, United States; Recruiting
Tina Watkins, Phone: 757-625-0151
David Pariser, MD, Principal Investigator

Starting date: June 2008
Ending date: June 2010
Last updated: October 7, 2008