Assessment and Tracking of Long-term Alefacept Safety

NCT ID: NCT00454701

Last Updated: 2013-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

1897 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-06-30

Study Completion Date

2012-02-29

Brief Summary

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Subjects exposed to alefacept are to be enrolled. Subjects will be contacted every 6 months to gather general health information.

Detailed Description

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There are no study-mandated tests, visits or clinical interventions after the 1st (enrolling) visit. After the patient is enrolled in the study, they will be contacted every 6 months to complete structured telephone interviews conducted by the ATLAS Study Center.

Conditions

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Psoriasis

Keywords

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Psoriasis Alefacept Amevive® Drug exposure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1. Amevive Exposure

Patients treated with alefacept for chronic plaque psoriasis

Alefacept exposure

Intervention Type DRUG

Observational

Interventions

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Alefacept exposure

Observational

Intervention Type DRUG

Other Intervention Names

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Amevive ASP0485

Eligibility Criteria

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Inclusion Criteria

* Psoriasis patients who are prescribed alefacept consistent with product labeling are eligible for enrollment.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vice President Medical Affairs

Role: STUDY_DIRECTOR

Astellas Pharma Global Development

Locations

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Total Skin and Beauty Dermatology Center

Birmingham, Alabama, United States

Site Status

Janet Cash

Birmingham, Alabama, United States

Site Status

Bay Shore Dermatology & Laser Surgery Center

Fairhope, Alabama, United States

Site Status

Eric Baum

Gadsden, Alabama, United States

Site Status

Ruth A Yates

Huntsville, Alabama, United States

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Mobile Dermatology

Mobile, Alabama, United States

Site Status

English Dermatology Centers

Phoenix, Arizona, United States

Site Status

Scottsdale Dermatology

Scottsdale, Arizona, United States

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Sheftel & Associates Dermatology

Tucson, Arizona, United States

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Ozark Dermatology Clinic

Fayetteville, Arkansas, United States

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Cyril E Severns

Fort Smith, Arkansas, United States

Site Status

Burke Pharmaceutical Research

Hot Springs, Arkansas, United States

Site Status

Little Rock Dermatology Clinic

Little Rock, Arkansas, United States

Site Status

East Bay Dermatology Medical Group Inc. DBA Center for Dermatology, Cosmetic & Laser Surgery, Inc

Fremont, California, United States

Site Status

East Bay Dermatology Medical Group Inc., DBA Center for Dermatology, Cosmetic and Laser Surgery

Fremont, California, United States

Site Status

Minarets Medical Group, Inc.

Fresno, California, United States

Site Status

John J. Guagenti, MD

Glendale, California, United States

Site Status

Scripps Clinic

La Mesa, California, United States

Site Status

Fairmont Dermatology

Lodi, California, United States

Site Status

California Skin Institute

Mountain View, California, United States

Site Status

Clinical Research Specialists, Inc.

Santa Monica, California, United States

Site Status

Advanced Dermatology

Centennial, Colorado, United States

Site Status

Dermatology & Laser Center at Harvard Park, PLLC

Denver, Colorado, United States

Site Status

D.B.A. Colorado West Dermatology

Grand Junction, Colorado, United States

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Jeremy Moss, MD

Bridgeport, Connecticut, United States

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Eric R. Wolf, MD

Groton, Connecticut, United States

Site Status

Bender and Kolenik MD, PC

Norwalk, Connecticut, United States

Site Status

Charles Halasz

Norwalk, Connecticut, United States

Site Status

Stuart Bender

Norwalk, Connecticut, United States

Site Status

Jeffrey Alter

Waterbury, Connecticut, United States

Site Status

Panzer Dermatology Assoc.

Newark, Delaware, United States

Site Status

Atlantic Skin and Cosmetic Surgery- P.C.

Wilmington, Delaware, United States

Site Status

Jerri L. Johnson MD, PA

Altamonte Springs, Florida, United States

Site Status

Center for Dermatology

Boca Raton, Florida, United States

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Jodi Fiedler

Boca Raton, Florida, United States

Site Status

Dermatology and Skin Surgery Center, PA

Celebration, Florida, United States

Site Status

Brent M Schillinger

Delray Beach, Florida, United States

Site Status

A.G.A. Clinical Trials

Hialeah, Florida, United States

Site Status

North Florida Dermatology Associates, P.A.

Jacksonville, Florida, United States

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Coastal Dermatology, PA

Jacksonville, Florida, United States

Site Status

A Center for Dermatology, Cosmetic and Laser Surgery

Jupiter, Florida, United States

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Associates in Medical and Surgical Dermatology

Naples, Florida, United States

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Dermatology & Laser Center

Orange Park, Florida, United States

Site Status

Reflections Dermatology & Center for Skin Care

Orlando, Florida, United States

Site Status

John L. Meisenheimer, MD

Orlando, Florida, United States

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Advanced Dermatology

Orlando, Florida, United States

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Ormond Beach Dermatology

Ormond Beach, Florida, United States

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Waters Edge Dermatology

Palm Beach Gardens, Florida, United States

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Mark Cheiken

Palm Coast, Florida, United States

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Timothy Kelly, MD, PA

Palm Harbor, Florida, United States

Site Status

Snyder & Le M.D. PA

Pembroke Pines, Florida, United States

Site Status

Kevin L Welch

Pensacola, Florida, United States

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Hecker Dermatology Group PA

Pompano Beach, Florida, United States

Site Status

Michael A. Scannon MD, PA

Tampa, Florida, United States

Site Status

Luis T. Menendez, MD, PA

Tampa, Florida, United States

Site Status

Neil S. Heskel, MD

Vero Beach, Florida, United States

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Sunnycoast Dermatology

Vero Beach, Florida, United States

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Emory University School of Medicine

Atlanta, Georgia, United States

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Darren Casey

Atlanta, Georgia, United States

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Georgia Skin Specialists

Atlanta, Georgia, United States

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Peachtree Dermatology Associates

Atlanta, Georgia, United States

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Family Dermatology-Cynthia A. Abbott, MD

Atlanta, Georgia, United States

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Allen B. Filstein, MD

Conyers, Georgia, United States

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East Metro Dermatology, PC

Conyers, Georgia, United States

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North Atlanta Dermatology

Duluth, Georgia, United States

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Dermatologic Surgery Specialist Inc.

Macon, Georgia, United States

Site Status

Paul S. Takiguchi- MD- Inc.

‘Aiea, Hawaii, United States

Site Status

Saltzer Medical Group, PA

Nampa, Idaho, United States

Site Status

Altman Dermatology Associates

Arlington Heights, Illinois, United States

Site Status

Thomas Brander

Bloomington, Illinois, United States

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Calumet Dermatology Associates S.C.

Calumet City, Illinois, United States

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Christie Clinic

Champaign, Illinois, United States

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Danilo Del Campo

Chicago, Illinois, United States

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Michael A. Greenberg, MD, Ltd.

Elk Grove Village, Illinois, United States

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North Suburban Dermatology Associates

Gurnee, Illinois, United States

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Dermatology Associates of LaGrange

LaGrange Highlands, Illinois, United States

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Soderstrom Dermatology Center

Peoria, Illinois, United States

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David Coynik

Peru, Illinois, United States

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Schaumburg Dermatology

Schaumburg, Illinois, United States

Site Status

Alan E. Lasser MD PC

Skokie, Illinois, United States

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Paul Getz

West Dundee, Illinois, United States

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Advanced Dermatology Associates, PC

Bloomington, Indiana, United States

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Spencer Dermatology Associates LLC

Crawfordsville, Indiana, United States

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Mitchell Bressack

Crown Point, Indiana, United States

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Fort Wayne Dermatology

Fort Wayne, Indiana, United States

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Tsu-Yi Chuang

Indianapolis, Indiana, United States

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Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, United States

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Randall Dermatology

West Lafayette, Indiana, United States

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Timothy Abrahamson

Urbandale, Iowa, United States

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Dermatology Associates

Waterloo, Iowa, United States

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Great Plains Dermatology- P.A.

Hays, Kansas, United States

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American Dermatology Associates

Shawnee, Kansas, United States

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Kansas Medical Clinic, PA

Topeka, Kansas, United States

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Moeller Dermatology, LLC

Wichita, Kansas, United States

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Melissa Knuckles

Corbin, Kentucky, United States

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LA Dermatology Assoc LLC

Baton Rouge, Louisiana, United States

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Dimitri Dermatology

Gretna, Louisiana, United States

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Eileen Ringel

Waterville, Maine, United States

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Benjamin Bernstein

Bel Air, Maryland, United States

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The Dermatology Group LLC

Chevy Chase, Maryland, United States

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Dermatology & Advanced Skin Care

Ellicott City, Maryland, United States

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Greater Washington Dermatology P.A.

Rockville, Maryland, United States

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Todd Colonna

Rockville, Maryland, United States

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Northeast Dermatology

Beverly, Massachusetts, United States

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Brigham and Women's Hospital

Boston, Massachusetts, United States

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Bruce Goldstein

Florence, Massachusetts, United States

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Mark Lewis

Marblehead, Massachusetts, United States

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Jay A. Goldstein, MD

Natick, Massachusetts, United States

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Kenneth M. Reed, MD

Quincy, Massachusetts, United States

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Ronald S. Nadel

Springfield, Massachusetts, United States

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Wendy McFalda, DO

Clarkston, Michigan, United States

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Drs. Iacobelli & DiGregorio, PC

Clinton Township, Michigan, United States

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Psoriasis and Eczema Treatment Center of Western Michigan

Grand Rapids, Michigan, United States

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Livonia Dermatology, PLLC

Livonia, Michigan, United States

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Somerset Skin Centre

Troy, Michigan, United States

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Midwest Center for Dermatology and Cosmetic Surgery

Warren, Michigan, United States

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Michael T. Siegel MD- P.C.

Waterford, Michigan, United States

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Jeffrey N Samuelson

Burnsville, Minnesota, United States

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Advancements In Derm

Edina, Minnesota, United States

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Jack C. Scott

Fridley, Minnesota, United States

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Steven E. Prawer

Fridley, Minnesota, United States

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The Dermatology Clinic- PLLC

Gulfport, Mississippi, United States

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Mark Gallardo

Hattiesburg, Mississippi, United States

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Andrew Berg

Kansas City, Missouri, United States

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Sharon K Tiefenbrunn

St Louis, Missouri, United States

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Associated Dermatology

Helena, Montana, United States

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Johnnie M Woodson

Las Vegas, Nevada, United States

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Las Vegas, Nevada, United States

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Robert B. Stromling, MD

Las Vegas, Nevada, United States

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Nashua Dermatology Associates

Nashua, New Hampshire, United States

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Psoriasis Treatment Center of Central NJ

East Windsor, New Jersey, United States

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North Bergen Dermatologic Group

Ridgewood, New Jersey, United States

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Buffalo Medical Group

Buffalo, New York, United States

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Bruce S. Stein

Flushing, New York, United States

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Advanced Dermatology

Fresh Meadows, New York, United States

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Frank De Mento

Garden City, New York, United States

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Garden City Dermatology, P.C.

Garden City, New York, United States

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Edmund Lee

Huntington, New York, United States

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Jeffrey P Schachne

Jefferson Valley, New York, United States

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Atlantic Dermatologic Associates, LLC

Lynbrook, New York, United States

Site Status

Orange Dermatology Assoc, PC

Monroe, New York, United States

Site Status

Peter S. Halperin's Office

New York, New York, United States

Site Status

Peter Accetta

Orchard Park, New York, United States

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Dermatology Partners of Western New York

Rochester, New York, United States

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Dermatique Dermedy Dermatology- PC

Smithtown, New York, United States

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Marina I Peredo, MD

Smithtown, New York, United States

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Josiane Lederman, MD, PC

Staten Island, New York, United States

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Joseph D. Sutton, MD

Suffern, New York, United States

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Susan E. Katz MD

The Bronx, New York, United States

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Martin Morell, MD

Utica, New York, United States

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Stanley A. Newfield

Valley Stream, New York, United States

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Alan B Schliftman

White Plains, New York, United States

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Colleen Demers

Williamsville, New York, United States

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Lynn A. Amarante, MD PC

Williamsville, New York, United States

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Davie Dermatology

Advance, North Carolina, United States

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Skyland Dermatology and Psychiatry

Asheville, North Carolina, United States

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Curtis W. Schupbach- MD

Charlotte, North Carolina, United States

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Andrus & Associates Dermatology, PA

Raleigh, North Carolina, United States

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Atlantic Dermatology Associates, P.A.

Wilmington, North Carolina, United States

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WHA Medical Clinic PLLC

Wilmington, North Carolina, United States

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William S. Mirando, MD, LLC

Ashtabula, Ohio, United States

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Eugene Conte

Centerville, Ohio, United States

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University Dermatology Consultants, Inc.

Cincinnati, Ohio, United States

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Martha Hickmann, MD

Dayton, Ohio, United States

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Joyce Lender

Elyria, Ohio, United States

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Northeast Dermatology & Cosmetic Surgery

Gahanna, Ohio, United States

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Judith Andreano

Strongsville, Ohio, United States

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Harvey L. Handler, MD

Sylvania, Ohio, United States

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Medical College of Ohio

Toledo, Ohio, United States

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Options Health Research

Tulsa, Oklahoma, United States

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Allergy, Asthma & Dermatology Research Centers, LLC

Lake Oswego, Oregon, United States

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Eric Olson

Springfield, Oregon, United States

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Paul Klas

Tualatin, Oregon, United States

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Robert M. Stiegel- M.D. LTD

Beaver, Pennsylvania, United States

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Lehigh Valley Dermatology

Bethlehem, Pennsylvania, United States

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Jan Brydon

Erie, Pennsylvania, United States

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David Amato

Harrisburg, Pennsylvania, United States

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Saye & Gette Dermatology Associates, PC

Harrisburg, Pennsylvania, United States

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Chad Mathews

Hermitage, Pennsylvania, United States

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Dermatology Associates of Lancaster

Lancaster, Pennsylvania, United States

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Stephanie Mackey

Lancaster, Pennsylvania, United States

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Allegheny Dermatology Assoc., PC

Monroeville, Pennsylvania, United States

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East Penn Dermatology

North Wales, Pennsylvania, United States

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Paddington Testing Co, Inc.

Philadelphia, Pennsylvania, United States

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Louis H. Martone, MD, PC

Pittsburgh, Pennsylvania, United States

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Neil M. Niren MD

Pittsburgh, Pennsylvania, United States

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Dermatology Associates of Plymouth Meeting- P.C.

Plymouth Meeting, Pennsylvania, United States

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Joseph Bikowski

Sewickley, Pennsylvania, United States

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Joel Seigel- MD

Washington, Pennsylvania, United States

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Sabrina Dowd

Williamsport, Pennsylvania, United States

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Clinical Partners, LLC

Johnston, Rhode Island, United States

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Paul T. Zaydon MD

Pawtucket, Rhode Island, United States

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Dermatology Associates of the Low Counties

Beaufort, South Carolina, United States

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Marta Hampton

Charleston, South Carolina, United States

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Rheumatology Associates

Charleston, South Carolina, United States

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The Dermatology Group, LLC

Columbia, South Carolina, United States

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McClerklin Skin and Laser Center

Columbia, South Carolina, United States

Site Status

John Humeniuk

Greenville, South Carolina, United States

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Lesly S. Davidson MD PA

Mt. Pleasant, South Carolina, United States

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Grand Strand Dermatology, LLC

Myrtle Beach, South Carolina, United States

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Hillcrest Dermatology Center, PA

Orangeburg, South Carolina, United States

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DeVore Dermatology, PA

Spartanburg, South Carolina, United States

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Palmetto Dermatology, PA

West Columbia, South Carolina, United States

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Midsouth Dermatology and Skin Cancer Center

Bartlett, Tennessee, United States

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Advanced Skin & Laser Center

Brentwood, Tennessee, United States

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Rivergate Dermatology Research Center

Goodlettsville, Tennessee, United States

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Dermatology Associates of Kingsport, PC

Kingsport, Tennessee, United States

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Dermatology Associates of Knoxville, PC

Knoxville, Tennessee, United States

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Delta Medical Ctr.

Memphis, Tennessee, United States

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Abigail James, NP, MSN

Nashville, Tennessee, United States

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Tennessee Clinical Research Center

Nashville, Tennessee, United States

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Derm & Skin Cancer Surgery Center

Allen, Texas, United States

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Arlington Center for Dermatology

Arlington, Texas, United States

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Bellaire Dermatology Associates

Bellaire, Texas, United States

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Alpha Therapy Center

Corpus Christi, Texas, United States

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Raymond Blackburn

Dallas, Texas, United States

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Betty J. Rajan

Fort Worth, Texas, United States

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Lisa Garner

Garland, Texas, United States

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West Houston Dermatology, PA

Houston, Texas, United States

Site Status

Lone Star Children's Medical PLLC

Houston, Texas, United States

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Dermatology and Laser Center

Irving, Texas, United States

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Steven J. Smith, MD

Kingwood, Texas, United States

Site Status

Mark S Wallis

Longview, Texas, United States

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Lubbock Dermatology and Skin Cancer Center

Lubbock, Texas, United States

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Dermatology of East Texas

Lufkin, Texas, United States

Site Status

Ashkan Ghorbani

Pasadena, Texas, United States

Site Status

Gregory W Thompson

San Antonio, Texas, United States

Site Status

Dermatology Research Associates of Tyler

Tyler, Texas, United States

Site Status

Rocky Mountain Dermatology

Logan, Utah, United States

Site Status

Aspen Clinical Research, LLC

Orem, Utah, United States

Site Status

Four Seasons Dermatology

South Burlington, Vermont, United States

Site Status

Georgia A Seely

Richmond, Virginia, United States

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Virginia Beach Dermatology Associates, PPLC

Virginia Beach, Virginia, United States

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Dermatology & Laser Center Northwest

Bellingham, Washington, United States

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Dermatology Associates, PLLC

Seattle, Washington, United States

Site Status

James Hu MD PC

Seattle, Washington, United States

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James M. Komorous MD PS

Tacoma, Washington, United States

Site Status

Eastern Washington Dermatology

Walla Walla, Washington, United States

Site Status

Layton Avenue Dermatology

Greenfield, Wisconsin, United States

Site Status

Aylesworth Dermatology SC

Rhinelander, Wisconsin, United States

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Cheyenne Dermatology- P.C.

Cheyenne, Wyoming, United States

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Winnipeg Clinic

Winnepeg, Manitoba, Canada

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Dermadvances Research

Winnipeg, Manitoba, Canada

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Douglas N. Keeling MD Dermatologist PC

Quispamsis, New Brunswick, Canada

Site Status

Nexus Clinical Research

St. John's, Newfoundland and Labrador, Canada

Site Status

St. John's, Newfoundland and Labrador, Canada

Site Status

NewLab Clinical Research, Inc.

St. John's, Newfoundland and Labrador, Canada

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Sudbury Skin Clinic

Greater Sudbury, Ontario, Canada

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Dermatrials Research

Hamilton, Ontario, Canada

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Limestone Dermatology & Laser Clinic

Kingston, Ontario, Canada

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Mediprobe Research, Inc.

London, Ontario, Canada

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The Guenther Dermatology Research Centre

London, Ontario, Canada

Site Status

Wellington Dermatology Associates

London, Ontario, Canada

Site Status

Lynderm Research, Inc.

Markham, Ontario, Canada

Site Status

John J. Turner, MD

Newmarket, Ontario, Canada

Site Status

A.M. Katz Medicine D.C.

Newmarket, Ontario, Canada

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Dermatology Clinic

North York, Ontario, Canada

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Skin Centre for Dermatology

Peterborough, Ontario, Canada

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Dermatology Associates

Toronto, Ontario, Canada

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Specialized Dermatology

Welland, Ontario, Canada

Site Status

Clinique de dermatologie Dr. Francois Bouchard

Alma, Quebec, Canada

Site Status

Francoise Giard

Gatineau, Quebec, Canada

Site Status

Innovaderm Research, Inc

Montreal, Quebec, Canada

Site Status

Siena Medical Research

Montreal, Quebec, Canada

Site Status

Giles P. Raymond

Pierrefonds, Quebec, Canada

Site Status

CRCMR Gilbert Inc.

Québec, Quebec, Canada

Site Status

(CRDQ) Centre De Recherche Dermatologique Du Quebec Metropolitan

Québec, Quebec, Canada

Site Status

Victoria East Medical Clinic

Regina, Saskatchewan, Canada

Site Status

Countries

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United States Canada

Other Identifiers

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C-736

Identifier Type: -

Identifier Source: secondary_id

0485-CL-0001

Identifier Type: -

Identifier Source: org_study_id