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A Double-Blind, Randomized, Parallel-Group, Vehicle-Controlled, Multicenter Study to Evaluate the Safety and Bioequivalence of a Generic XXXX and Reference Listed XXXX and Compare Both Active Treatments to a Vehicle Control in the Treatment of Mild to Moderate Atopic Dermatitis

Purpose of study

To compare the safety and efficacy profiles of XXXX and Reference Listed XXXX and compare both active treatments to a vehicle control in the treatment of mild to moderate atopic dermatitis.

Eligibility

  • Ages eligible for the study: at least 12 years of age
  • Genders eligible for the study: Male and female

Criteria

Key Inclusion Criteria

  • Milder to moderate atopic dermatitis with a minimum of 7.5% body surfaces area (BSA) involvement
  • Male and Female ages at least 12 years of age

Key Exclusion Criteria

  • Treatment for atopic dermatitis with systemic medications, topical agents, and parenteral biological/monoconal antibody agents, within specific time period prior to dosing.
  • Use of prescription drugs, sedative antihistamine, medical devices for treatment of AD, and topical products containing urea and/or ceramides within 1specific time period prior to dosing

Locations

Alabama
Clinical Research Center of Alabama
Birmingham, AL 35209
Contact: Kim Robinson 205-871-9661
Principal Investigator:  Weily Soong, MD

Clinical Research Center of Alabama, LLC
Hoover, AL 35244
Contact: Kim Robinson 205-209-4100
Principal Investigator:  Maxcie M Sikora, MD

California
Medical Center for Clinical Research
San Diego, CA  92108
Contact: Karen Mylerberg 619-521-2830
Principal Investigator:  William David Koltun, MD

MD Studies, Inc
Fountain Valley, CA  92708
Contact: Mylinh Do, MBA, CCRC 714-241-1332
Principal Investigator:  Ronald Schilling, MD

TCR Medical Corporation
San Diego, CA  92123
Contact:Bethany Parker 858-571-6800
Principal Investigator:  Neal D. Bhatia, MD

Florida
Dermatology of Boca
Boca Raton, FL 33431
Contact: Steve Frent  561-362-8000
Principal Investigator:  Jeffrey S. Fromowitz, MD

Florida Academic Centers Research and Education
Coral Gables, FL 33134
Contact: Fabio Azevedo 305-324-2110
Principal Investigator:  Francisco A. Kerdel, MD

Advance Research Center, LLC
Miami, FL 33165
Contact: Marisela Gonzalez, MD 305-888-0410
Principal Investigator:  Marisela Gonzalez, MD

Georgia
Clinical Research Atlanta
Stockbridge, GA 30281
Contact:  Michelle Sowell 770-507-6867
Principal Investigator:  Nathan Segall, MD, CPI

Aeroallergy Research Laboratories of Savannah, Inc
Savannah, GA 31406
Contact:  Susie Gault, RN, CCRC 912-356-3619
Principal Investigator:  Brad Henry Goodman, MD, CPI

Illinois
Arlington Dermatology
Arlington Hts, IL 60005
Contact:  Ursula Cholewa 847-392-5440
Principal Investigator:  Michael Bukhalo, MD

Indiana
DS Research
New Albany, IN 47150
Contact:  Nina Scott 502-373-2849
Principal Investigator:  Megan N. Landis, MD

Kentucky
DS Research
Louisville, KY 40202
Contact:  Nina Scott 502-585-9059
Principal Investigator:  Joseph F. Fowler, Jr., MD

Minnesota
Minnesota Clinical Study Center
Fridley, MN 55432
Contact: Dawn Snow 763-571-4200
Principal Investigator:  Steven E. Kempers, MD

New Hampshire
ActivMed Practices & Research, Inc
Portsmouth, NH 87106
Contact:  Ashley Skukalek 603-319-8863
Principal Investigator:  Abel D. Jarell, MD. FAAD

New Mexico
Academic Dermatology Associates
Albuquerque, NM 87106
Contact:  Alicia D. Bucko, DO, JD 505-247-4220
Principal Investigator:  Alicia D. Bucko, DO, JD

New York
Pinkas E. Lebovits, MD, PC
New York City, NY 10019
Contact:  Anastassiya Tretyakova 212-757-7010
Principal Investigator:  Pinkas E. Lebovits, MD

North Carolina
Dermatology Consulting Services
High Point, NC 27262
Contact:  Zoe Diana Draelos, MD 336-841-2040
Principal Investigator:  Zoe Diana Draelos, MD

PMG Research of Winston-Salem, LLC
Winston-Salem, NC 27103
Contact: Annette Wood awood@pmg-research.com
Principal Investigator:  Debra Chih-Fen Liu, MD

Rhode Island
Dermatology Clinic
Providence, RI 02903
Contact:  Steven Knapp 401-444-7853
Principal Investigator:  Jennie J. Muglia, MD

Tennessee
Rivergate Dermatology Clinical Research Center, PLLC
Goodlettsville, TN 37072
Contact:  Janet Reed, LPN, CCRC 615-859-7546
Principal Investigator:  Keith H. Loven, MD, CPI

WR-ClinSearch, LLC (dba Clinsearch)
Chattanooga, TN 37421
Contact:  Christy Schmeck 423-698-4584
Principal Investigator:  Richard A. Krause, MD

Texas
Synexus US, L.P.
Plano, TX 75093
Contact:  Enrique Echaniz 972-499-4601
Principal Investigator:  Frances B. Herbert, MD

Houston Center for Clinical Research
Sugarland, TX 77479
Contact:  Dr Aparna Tamirisa 832-929-6221
Principal Investigator:  Aparna Tamirisa, MD

ACRC Trials/ Innovative Dermatology
Plano, TX 75024
Contact:  Heemah Marwah 972-354-1520
Principal Investigator:  Seemal Desai, MD, FAAD

DermResearch New Braunfels
New Braunfels, TX 78130
Contact: Justin W. Withers 830-387-5768
Principal Investigator:  Vicente Quintero, MD

Utah
Dermatology Research Center, Inc
Salt Lake City, UT 84117
Contact:  Laura J. Riley, CCRC 801-269-0135
Principal Investigator:  Leonard J. Swinyer, MD, FAAD, CPI

Wee Care Pediatrics
Salt Lake City, UT 84041
Contact:  Nancy J. Cleverley, CCRC, CCRP
Principal Investigator:  Michael Patrick Husseman, MD

Virginia
Clinical Research Partner, LLC
Richmond, VA 23220
Contact:  Tina Lee 804-477-3045
Principal Investigator:  Robert S. Call, MD