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NCT06979453RecruitingPhase 3

A Study to Evaluate the Efficacy, Safety, and Drug Levels of Deucravacitinib (BMS-986165) in Adolescent Participants With Moderate to Severe Plaque Psoriasis

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Deucravacitinib in Adolescent Participants (12 Years to Less Than 18 Years) With Moderate to Severe Plaque Psoriasis

Source: ClinicalTrials.gov · Last updated 27 Oct 2026

Brief summary (registry, in English)

The purpose of this study is to evaluate the efficacy, safety, and drug levels of Deucravacitinib (BMS-986165) in adolescent participants with moderate to severe plaque psoriasis

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
366 (estimated)
First submitted
13 May 2025
Start date
3 Dec 2025
Primary completion date
12 Oct 2029
Lead sponsor
Bristol-Myers Squibb
Diseases
Psoriasis
NCT number
NCT06979453
EU CT number
2023-506296-97-00
EudraCT number
2023-506296-97

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 366
  • From 3 Dec 2025 to the primary completion date, 12 Oct 2029
  • 131 sites in 16 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Participants must not have a history of serious bacterial, fungal, or viral infection requiring hospitalization and intravenous (IV) antimicrobial treatment within 60 days prior to Day 1.
  • Participants must not have any untreated bacterial infection within 60 days prior to Day 1.
  • Participants must not have received live vaccines or BCG within 60 days prior to Day 1 or plans to receive a live vaccine during the study, or within 60 days after completing study intervention.
  • Participants must not have had any prior exposure to deucravacitinib.
  • Participants must not have received any medication that is specifically prohibited.

Other illness

  • Participants must not have non-plaque psoriasis (ie, guttate, inverse, pustular, erythrodermic, or drug-induced psoriasis) or any skin condition other than plaque psoriasis that could interfere with assessments of treatment effect at Screening or Day 1.
  • Participants must not have any ongoing evidence of chronic bacterial infection (eg, chronic pyelonephritis, chronic osteomyelitis, chronic bronchiectasis).
  • Participants must not have herpes simplex/zoster, active tuberculosis (TB), hepatitis C virus (HCV), hepatitis B virus (HBV), human immunodeficiency virus (HIV) infection-related exclusions.
  • Participants must not have any major illness/condition or evidence of an unstable clinical condition (eg, renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, psychiatric, neurologic, immunologic, or local active infection/infectious illness) that, in the investigator's judgment or after consultation with the Sponsor's Medical Monitor, will substantially increase the risk to the participant if he or she participates in the study.
  • Participants must not have cancer or history of cancer (solid organ or hematologic including myelodysplastic syndrome) or lymphoproliferative disease within the previous 5 years.

Lab values

  • Participants must not have a laboratory finding that is exclusionary.

Other

  • Participants must not weigh \< 30.0 kg at Screening and Day 1.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Who the study is looking for

  • Participants must have stable plaque psoriasis for 6 months or more prior to Screening.
  • Participants must have moderate to severe psoriasis defined by:.
    • Psoriasis Area and Severity Index (PASI) ≥ 12, at screening visit and Day 1.
  • Static Physician's Global Assessment (sPGA) ≥ 3, at screening visit and Day 1.
  • Body Surface Area (BSA) ≥ 10% involvement, at screening visit and Day 1.
    • \- A female (as assigned at birth) participant is eligible to participate if she is not pregnant or breastfeeding, and at least 1 of the following conditions applies:.
  • Is not an individual of childbearing potential (IOCBP).
  • Is an IOCBP and using a contraceptive method that is highly effective (with a failure rate of \< 1% per year) during the study intervention period and for at least 3 days after discontinuation of the study intervention and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction for the same period.

Age in the registry: 12 years to 17 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (131)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
CONEXA Investigacion Clinica S.A.
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Buenos AiresArgentinaRecruiting
Hospital de Niños Dr. Ricardo Gutiérrez
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Buenos AiresArgentinaRecruiting
Hospital Italiano de Buenos Aires
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Buenos AiresArgentinaRecruiting
Derma Internacional
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Buenos AiresArgentinaRecruiting
Instituto de Neumonologia Y Dermatologia
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Ciudad Autonoma de Buenos AiresArgentinaRecruiting
Psoriahue
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Ciudad Autonoma de Buenos AiresArgentinaRecruiting
Centro de Investigaciones Médicas Tucuman
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SAN M. de TucumanArgentinaRecruiting
Universitair Ziekenhuis Gent
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GentBelgiumRecruiting
Centre Hospitalier Universitaire de Liège
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LiègeBelgiumRecruiting
Cliniques Universitaires Saint-Luc
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Sint-Lambrechts-WoluweBelgiumRecruiting
-
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CampinasBrazilNot yet recruiting
Hospital Universitário Evangélico Mackenzie
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CuritibaBrazilRecruiting
Hospital Moinhos de Vento
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Porto AlegreBrazilRecruiting
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Porto AlegreBrazilNot yet recruiting
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (USP) - HCFMRP
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Ribeirão PretoBrazilRecruiting
Centro de Pesquisas da Clínica IBIS
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SalvadorBrazilRecruiting
-
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São PauloBrazilNot yet recruiting
Alberta Dermasurgery Centre
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EdmontonCanadaRecruiting
Dermeffects
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LondonCanadaRecruiting
-
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MontrealCanadaNot yet recruiting
The Centre for Dermatology
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Richmond HillCanadaRecruiting
Skincare Studio
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St. John'sCanadaRecruiting
AvantDerm
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TorontoCanadaRecruiting
The Hospital for Sick Children
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TorontoCanadaRecruiting
-
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WinnipegCanadaNot yet recruiting
Peking University Third Hospital
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BeijingChinaRecruiting
Beijing Children's Hospital, Capital Medical University
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BeijingChinaRecruiting
Hunan Children's Hospital
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ChangshaChinaRecruiting
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ChengduChinaNot yet recruiting
Guangdong Province Dermatology Hospital
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GuangzhouChinaRecruiting
The Affiliated Hospital of Hebei University of Engineering
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HandanChinaRecruiting
The First People's Hospital of Hangzhou
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HangzhouChinaRecruiting
Shandong Provincial Dermatology Hospital and Shandong Institute of Dermatology and Venereology
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JinanChinaRecruiting
Shanghai Skin Disease Hospital
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ShanghaiChinaRecruiting
The University of Hong Kong-Shenzhen Hospital
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ShenzhenChinaRecruiting
People's Hospital of Henan Province
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ZhengzhouChinaRecruiting
-
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BarranquillaColombiaNot yet recruiting
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BogotaColombiaNot yet recruiting
-
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MedellínColombiaNot yet recruiting
-
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MedellínColombiaNot yet recruiting
Charite Universitaetsmedizin Berlin KöR
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BerlinGermanyRecruiting
Technische Universitaet Dresden
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DresdenGermanyRecruiting
Universitaetsklinikum Erlangen AöR
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ErlangenGermanyRecruiting
BAG Dres. med. Quist PartG
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MainzGermanyRecruiting
Universitaet Muenster
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MuensterGermanyRecruiting
Hospital de la Santa Creu i Sant Pau
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BarcelonaSpainRecruiting
Hospital Sant Joan de Déu
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BarcelonaSpainRecruiting
Grupo Pedro Jaén
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MadridSpainRecruiting
Hospital Universitario 12 de Octubre
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MadridSpainRecruiting
CHUS - Hospital Clinico Universitario
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Santiago de Compostela- A CorunaSpainRecruiting
Clinexpert Kft.
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Budapest IIIHungaryRecruiting
University of Debrecen
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DebrecenHungaryRecruiting
University of Szeged
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SzegedHungaryRecruiting
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
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BolognaItalyRecruiting
Università Cattolica del Sacro Cuore
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RomeItalyRecruiting
Azienda Ospedaliera Policlinico Universitario Tor Vergata
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RomeItalyRecruiting
-
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Chihuahua CityMexicoNot yet recruiting
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MéridaMexicoNot yet recruiting
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Mexico CityMexicoNot yet recruiting
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MonterreyMexicoNot yet recruiting
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TolucaMexicoNot yet recruiting
Arké SMO S.A de C.V
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VeracruzMexicoRecruiting
Instituto Dermatologico de Jalisco
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ZapopanMexicoRecruiting
Specderm Poznanska sp.j.
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BialystokPolandRecruiting
La Clinique Centrum Dermatologii i Estetyki
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GarwolinPolandRecruiting
DERMED Centrum Medyczne Sp. z o.o.
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LodzPolandRecruiting
Luxderm Specjalistyczny Gabinet Dermatologiczny Prof. Dr. Hab. N. Med. Dorota Krasowska
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LublinPolandRecruiting
Etyka Osrodek Badan Klinicznych Tomasz Pesta S.K.A.
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OlsztynPolandRecruiting
Royalderm Sp. z o.o.
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WarsawPolandRecruiting
Futuremeds Sp. z o.o.
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WarsawPolandRecruiting
Klinika Ambroziak Sp. z o.o.
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WarsawPolandRecruiting
-
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BayamónPuerto RicoNot yet recruiting
-
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CaguasPuerto RicoNot yet recruiting
GCM Medical Group, PSC - Hato Rey Site
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San JuanPuerto RicoRecruiting
Policlinica CCBR S.R.L.
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BucharestRomaniaRecruiting
Lotus Med S.R.L.
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BucharestRomaniaRecruiting
Spitalul Clinic Judetean De Urgenta Cluj
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Cluj-NapocaRomaniaRecruiting
Centrul de Medicina de Familie
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IașiRomaniaRecruiting
Policlinica Providența
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IașiRomaniaRecruiting
New Derm Clinical SRL
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TimișoaraRomaniaRecruiting
Kaohsiung Veterans General Hospital
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Kaohsiung CityTaiwanRecruiting
Chang Gung Memorial Hospital at Kaohsiung
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Kaohsiung Niao Sung DistTaiwanRecruiting
National Taiwan University Hospital
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TaipeiTaiwanRecruiting
Chang Gung Medical Foundation-Linkou Branch
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TaoyuanTaiwanRecruiting
-
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AmmonUnited StatesNot yet recruiting
Dermatology Affiliates Research Institute
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AtlantaUnited StatesRecruiting
-
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BirminghamUnited StatesNot yet recruiting
-
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BirminghamUnited StatesWithdrawn
Apex Clinical Research Center - Canton
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CantonUnited StatesRecruiting
-
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ClearwaterUnited StatesNot yet recruiting
-
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CliftonUnited StatesNot yet recruiting
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ColumbiaUnited StatesNot yet recruiting
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ColumbiaUnited StatesNot yet recruiting
Henry Ford Medical Center
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DetroitUnited StatesRecruiting
C.S. Mott Clinical Research Center (CRC)
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DetroitUnited StatesRecruiting
-
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Fountain ValleyUnited StatesNot yet recruiting
Center For Dermatology Clinical Research, Inc.
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FremontUnited StatesRecruiting
ObjectiveHealth - Goodlettsville Dermatology Research
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GoodlettsvilleUnited StatesRecruiting
-
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HickoryUnited StatesCompleted
-
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HoustonUnited StatesNot yet recruiting
Dawes Fretzin Clinical Research Group, LLC
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IndianapolisUnited StatesRecruiting
JDR Dermatology Research
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Las VegasUnited StatesRecruiting
Dermatology and Skin Cancer Center
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Lee's SummitUnited StatesRecruiting
Apex Clinical Research Center
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LorainUnited StatesRecruiting
Dermatology Research Associates
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Los AngelesUnited StatesRecruiting
Life Clinical Trials
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MargateUnited StatesRecruiting
Apex Clinical Research Center
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Mayfield HeightsUnited StatesRecruiting
-
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MetairieUnited StatesNot yet recruiting
Skin Research of South Florida
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MiamiUnited StatesRecruiting
Wellness Clinical Research
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Miami LakesUnited StatesRecruiting
Kuchnir Dermatology & Dermatologic Surgery
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MilfordUnited StatesRecruiting
Frontier Derm Partners
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Mill CreekUnited StatesRecruiting
Kentucky Advanced Medical Research LLC
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MurrayUnited StatesRecruiting
-
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NashvilleUnited StatesCompleted
-
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New YorkUnited StatesNot yet recruiting
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NorfolkUnited StatesNot yet recruiting
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NorthridgeUnited StatesActive, not recruiting
Paddington Testing Company
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PhiladelphiaUnited StatesRecruiting
-
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PhoenixUnited StatesWithdrawn
Aura Dermatology
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RobbinsvilleUnited StatesRecruiting
Dermatology and Skin Cancer Specialists, LLC
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RockvilleUnited StatesRecruiting
-
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SacramentoUnited StatesNot yet recruiting
Texas Dermatology and Laser Specialists
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San AntonioUnited StatesRecruiting
Advanced Medical Research, PC.
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Sandy SpringsUnited StatesRecruiting
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SouthlakeUnited StatesNot yet recruiting
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SpokaneUnited StatesNot yet recruiting
USF Health
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TampaUnited StatesRecruiting
MOORE Clinical Research, Inc. d/b/a TrueBlue Clinical Research
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TampaUnited StatesRecruiting
-
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The BronxUnited StatesNot yet recruiting
Golden State Dermatology - Walnut Creek - Ygnacio Valley Road
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Walnut CreekUnited StatesRecruiting
Paradigm Clinical Research, LLC
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Wheat RidgeUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.