A Study of Baricitinib (LY3009104) in Children From 6 Years to Less Than 18 Years of Age With Alopecia Areata

Last updated: February 24, 2025
Sponsor: Eli Lilly and Company
Overall Status: Active - Recruiting

Phase

3

Condition

Alopecia

Hair Loss

Treatment

Placebo

Baricitinib

Clinical Study ID

NCT05723198
16875
I4V-MC-JAIO
2022-502700-78-00
  • Ages 6-17
  • All Genders

Study Summary

The main purpose of this study is to determine the efficacy and safety of baricitinib for the treatment of severe or very severe alopecia areata (hair loss) in children from 6 years to less than 18 years of age.

The study is divided into 4 periods, a 5-week Screening period, a 36-week Double-Blind Treatment Period, an approximately 2-year Long-term Extension Period, and a 4-week Post-treatment Follow-up period.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Enrollment will be fully sequential by age group, with adolescents (12 to less than 18 years old) enrolling before children (6 to less than 12 years old).

  • Have severe areata alopecia (AA) for at least 1 year

  • Diagnosis for at least 1 year

  • Current AA episode of at least 6 months' duration

  • SALT score ≥50% at screening and baseline

  • History of trial and failure with at least 1 available treatment (topical or other)for AA

  • History of psychological counseling related to AA

  • Current episode of severe AA of less than 8 years.

  • Note: Participants who have severe AA for ≥8 years may be enrolled if episodesof regrowth, spontaneous or under treatment, have been observed on the affectedareas over the past 8 years.

Exclusion

Exclusion Criteria:

  • Primarily "diffuse" type of AA (characterized by diffuse hair shedding).

  • Are currently experiencing other forms of alopecia including, but not limited totrichotillomania, telogen effluvium, chemotherapy-induced hair loss, or any otherconcomitant conditions (for example, tinea capitis, psoriasis, lupus erythematosus,or secondary syphilis) that would interfere with evaluations of the effect of studymedication on AA.

  • Are largely or wholly incapacitated permitting little or no self-care, such as beingbedridden

  • Have uncontrolled arterial hypertension

  • Have had major surgery within 8 weeks prior to screening or will require majorsurgery during the study

  • Have a history or presence of cardiovascular, respiratory, hepatic,gastrointestinal, endocrine, hematological, neurological, or neuropsychiatricdisorders or any other serious and/or unstable illness that, in the opinion of theinvestigator, could constitute an unacceptable risk when taking IP or interfere withthe interpretation of data.

  • Have a positive test for hepatitis B virus (HBV) infection

  • Have hepatitis C virus (HCV) infection (positive for anti hepatitis C antibody withconfirmed presence of HCV ribonucleic acid [RNA]).

  • Have evidence of human immunodeficiency virus (HIV) infection and/or positive HIVantibodies.

Study Design

Total Participants: 595
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
February 27, 2023
Estimated Completion Date:
August 31, 2029

Connect with a study center

  • Fundación Respirar

    Buenos Aires, Buenos Air C1426ABP
    Argentina

    Site Not Available

  • Centro de Investigaciones Metabólicas (CINME)

    Caba, Buenos Aires C1027AAP
    Argentina

    Active - Recruiting

  • Buenos Aires Skin

    Ciudad Autonoma Buenos Aires, Buenos Aires C1055AA0
    Argentina

    Active - Recruiting

  • Instituto de Neumonología Y Dermatología

    Ciudad Autonoma Buenos Aires, Buenos Aires C1425BEA
    Argentina

    Active - Recruiting

  • Hospital Universitario Austral

    Pilar, Buenos Aires 1629
    Argentina

    Site Not Available

  • Hospital del Niño Jesus

    San Miguel de Tucuman, Provincia De Tucuman 4000
    Argentina

    Active - Recruiting

  • Centro Medico Privado de Reumatologia

    SAN M. DE Tucuman, Tucumán T4000AXL
    Argentina

    Active - Recruiting

  • Centro Medico Privado de Reumatologia

    San Miguel De Tucumán, Tucumán T4000AXL
    Argentina

    Site Not Available

  • Psoriahue Medicina Interdisciplinaria

    Buenos Aires, C1425DKG
    Argentina

    Active - Recruiting

  • Skin and Cancer Foundation Australia - Darlinghurst Clinic

    Darlinghurst, New South Wales 2010
    Australia

    Active - Recruiting

  • The Skin Hospital

    Darlinghurst, New South Wales 02010
    Australia

    Active - Recruiting

  • Royal North Shore Hospital

    Saint Leonards, New South Wales 2065
    Australia

    Site Not Available

  • Royal North Shore Hospital

    St Leonards, New South Wales 2065
    Australia

    Site Not Available

  • Veracity Clinical Research

    Woolloongabba, Queensland 4102
    Australia

    Site Not Available

  • Veracity Clinical Research Pty Ltd

    Woolloongabba, Queensland 4102
    Australia

    Site Not Available

  • Veracity Clinical Research Pty Ltd

    Wooloongabba, Queensland 4102
    Australia

    Active - Recruiting

  • Sinclair Dermatology

    Melbourne, Victoria 3002
    Australia

    Active - Recruiting

  • Institute for Skin, Health, and Immunity

    Mitcham, Victoria 3132
    Australia

    Active - Recruiting

  • Dermatology Research Institute

    Calgary, Alberta T2J 7E1
    Canada

    Site Not Available

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    Surrey, British Columbia V3R 6A7
    Canada

    Active - Recruiting

  • Wiseman Dermatology Research Inc.

    Winnipeg, Manitoba R3M 3Z4
    Canada

    Active - Recruiting

  • Skin Health

    Cobourg, Ontario K9A 0Z4
    Canada

    Active - Recruiting

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    Markham, Ontario L3P 1X2
    Canada

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  • Research Toronto

    Toronto, Ontario M4W 2N2
    Canada

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  • CHRU de Brest - Hôpital Morvan

    Brest CEDEX 2, 29609
    France

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    Marseille, 13005
    France

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    Marseille, 13005
    France

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    Nantes, 44093
    France

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    Nice, 6202
    France

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    Nice, 06202
    France

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    Nice cedex 3, 06202
    France

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    Paris, 75010
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  • Hôpital Clocheville Chru-Tours Département Dermatologie

    Tours Cedex, 37044
    France

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    Muenchen, Bayern 80802
    Germany

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    München, Bayern 80802
    Germany

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    Bad Bentheim, Niedersachsen 48455
    Germany

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    Dresden, Sachsen 01307
    Germany

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    Luebeck, Schleswig-Holstein 23538
    Germany

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    Lübeck, Schleswig-Holstein 23538
    Germany

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    Berlin, 10117
    Germany

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    Dresden, 01307
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    Frankfurt am Main, 60590
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    Frankfurt am Main, 60590
    Germany

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    Halle, 06120
    Germany

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    Hamburg, 22149
    Germany

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    Hamburg, 22149
    Germany

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  • Universitaetsklinikum Hamburg-Eppendorf

    Hamburg, 20246
    Germany

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    Mainz, 55128
    Germany

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    Muenchen, 80802
    Germany

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  • University of Muenster

    Muenster, 48149
    Germany

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    Muenster, 48149
    Germany

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  • University of Szeged

    Szeged, Csongrad 6720
    Hungary

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    Debrecen, Hajdu-Bihar 4032
    Hungary

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    Kaposvar, Somogy 7400
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    Kaposvár, Somogy 7400
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    Budapest, 1033
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    Budapest, 1033
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    Debrecen, 4032
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    Pecs, 7632
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    Pecs, 7632
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    Szeged, 6720
    Hungary

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    Kurume, Fukuoka 830-0011
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    Miyagi-gun, Miyagi 981 0112
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    Hamamatsu, Shizuoka 431-3192
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    Mitaka, Tokyo 181-8611
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    Shinjuku-ku, Tokyo 160-0023
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    Ube, Yamaguchi 755-8505
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    Niigata, 951-8520
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    Osaka, 545-8586
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    Cheonan-si, Chungcheongnam-do 31116
    Korea, Republic of

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    Cheonan, Chungcheongnam-do [Chungnam] 31116
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    Seongnam-si, Geonggi-do 13620
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    Suwon, Gyeonggi-do 16499
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    Incheon, Incheon-gwangyeoksi [Incheon] 22332
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    Daejeon, Jung-gu 34134
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    Daegu, Korea 41944
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    Busan, Pusan-Kwangyǒkshi 49241
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  • Kyunghee University Hospital at Gangdong

    Seoul, Seoul, Korea 05278
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  • Seoul National University Hospital

    Seoul, Seoul-teukbyeolsi [Seoul] 03080
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  • Kyung Pook National University Hospital

    Jung-gu, Taegu-Kwangyǒkshi 41944
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  • Kyungpook National University Hospital

    Jung-gu, Taegu-Kwangyǒkshi 41944
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  • Chungnam national university hospital

    Daejeon, 35015
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  • Jeonbuk National University Hospital

    Jeonju-si, 54907
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  • Chung-Ang University College of Medicine - Chung-Ang University Hospital (CAUH)

    Seoul, 06973
    Korea, Republic of

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  • Chung-Ang University Hospital

    Seoul, 06973
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  • Chungang University Hospital

    Seoul, 06973
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    Site Not Available

  • Konkuk University Medical Center

    Seoul, 05030
    Korea, Republic of

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  • Severance Hospital, Yonsei University Health System

    Seoul, 03722
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    Active - Recruiting

  • The Catholic University of Korea, Eunpyeong St. Mary's Hospital

    Seoul, 03312
    Korea, Republic of

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  • Grupo Clínico CATEI SC

    Guadalajara, Jalisco 44638
    Mexico

    Site Not Available

  • Hospital Universitario Dr. Jose Eleuterio Gonzalez

    Monterrey, NL 64460
    Mexico

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  • Eukarya PharmaSite

    Monterrey, Nuevo León 64718
    Mexico

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  • Hospital Angeles Chihuahua Unidad de Investigacion Clinica

    Chihuahua, 31217
    Mexico

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  • Innovacion y Desarrollo de Estrategias en Salud SA de CV

    Mexico City, 14090
    Mexico

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  • Mexico Centre for Clinical Research

    Mexico City, 6720
    Mexico

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  • Arké SMO S.A de C.V

    Veracruz, 91910
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  • Dermoklinika Centrum Medyczne s.c. M. Kierstan J. Narbutt A. Lesiak

    Lodz, Lodzkie 90-436
    Poland

    Active - Recruiting

  • Specjalistyczny Gabinet Dermatologiczny s.c.

    Krakow, Malopolskie 30 002
    Poland

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  • High-Med Przychodnia Specjalistyczna

    Warsaw, Masovian 01-817
    Poland

    Site Not Available

  • Centralny Szpital Kliniczny MSWiA

    Warsaw, Małopolskie 02-507
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    Warsaw, Małopolskie 02-507
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  • Kliniczny Szpital Wojewodzki Nr 1 im. Fryderyka Chopina w Rzeszowie

    Rzeszow, Podkarpackie 35 055
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  • Centrum Badan Klinicznych PI-House sp. z o.o.

    Gdansk, Pomorskie 80-546
    Poland

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  • Provita Sp.zo.o. Centrum Medyczne Angelius

    Katowice, Śląskie 40-611
    Poland

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  • NZOZ Specjalistyczny Osrodek Dermatologiczny DERMAL

    Bialystok, 15 453
    Poland

    Site Not Available

  • Medicover Integrated Clinical Services (MICS) Centrum Medyczne Bydgoszcz

    Bydgoszcz, 85 065
    Poland

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  • CareClinic

    Katowice, 40 568
    Poland

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  • Centrum Medyczne Angelius Provita

    Katowice, 40-611
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  • Gabinet Dermatlogiczny

    Kielce, 25-155
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  • Gabinet Dermatlogiczny. Beata Krecisz

    Kielce, 25-155
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    Kielce, 25-155
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  • DERMEDIC Jacek Zdybski

    Ostrowiec Swietokrzyski, 27-400
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    Rzeszow, 35-055
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  • DERMEDIC Jacek Zdybski

    Swietokrzyski, 27 400
    Poland

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  • Laser Clinic Dermatologia Laserowa Medycyna Estetyczna

    Szczecin, 70-332
    Poland

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  • Centralny Szpital Kliniczny MSWiA

    Warszawa, 02-507
    Poland

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  • Centrum Medyczne Evimed

    Warszawa, 02-625
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  • Klinika Ambroziak Sp. Z.O.O.

    Warszawa, 02-953
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  • Provita Poliklinika Sp. z o

    Warszawa, 02-647
    Poland

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  • Provita Poliklinika Sp. z o.o.

    Warszawa, 02 647
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  • Royalderm Agnieszka Nawrocka

    Warszawa, 02 692
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  • CityClinic Przychodnia Lekarsko-Psychologiczna

    Wroclaw, 50-566
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  • Hospital del Mar

    Barcelona, Catalunya [Cataluña] 08003
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  • Parc de Salut Mar - Hospital del Mar

    Barcelona, Catalunya [Cataluña] 08003
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  • Hospital Universitario Quironsalud Madrid

    Pozuelo de Alarcon, Madrid 28223
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    Bilbao, Vizcaya 48013
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    Alicante, 03010
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    Badalona, 08916
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    Badalona, 08916
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    Madrid, 28006
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    Madrid, 28041
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    Madrid, 28041
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    Madrid, 28031
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    Valencia, 46014
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    Valencia, 46014
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    New Taipei City, New Taipei 235
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    Taoyuan, 33305
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    Taoyuan County, 33305
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    Birmingham, Alabama 35205
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    Birmingham, Alabama 35233
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    Scottsdale, Arizona 85255
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    Encinitas, California 92024
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    San Francisco, California 94118
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    Fairfield, Connecticut 06824
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    Boca Raton, Florida 33486
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    Coral Gables, Florida 33134
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    Doral, Florida 33122
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    Tampa, Florida 33613
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    Macon, Georgia 31217
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    Chicago, Illinois 60611
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    Indianapolis, Indiana 46250
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    Bay City, Michigan 48706
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    Omaha, Nebraska 68144
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    Bronx, New York 10467
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    Charlotte, North Carolina 28277
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    Charlotte, North Carolina 28277
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    Cincinnati, Ohio 45229
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    Tulsa, Oklahoma 74136
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    Tulsa, Oklahoma 74136
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    Portland, Oregon 97210
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    Exton, Pennsylvania 19341
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    Charleston, South Carolina 29425
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    United States

    Site Not Available

  • Texas Dermatology and Laser Specialists

    San Antonio, Texas 78218
    United States

    Active - Recruiting

  • Complete Dermatology

    Sugar Land, Texas 77479
    United States

    Active - Recruiting

  • University of Utah MidValley Dematology

    Murray, Utah 84107
    United States

    Site Not Available

  • Virginia Clinical Research

    Norfolk, Virginia 23502
    United States

    Active - Recruiting

  • Virginia Clinical Research, Inc.

    Norfolk, Virginia 23502
    United States

    Active - Recruiting

  • University of Wisconsin-Madison

    Madison, Wisconsin 53715
    United States

    Active - Recruiting

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