To Assess the Efficacy and Safety of SCD-044 in the Treatment of Moderate to Severe Atopic Dermatitis
NCT ID: NCT04684485
Last Updated: 2025-12-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
250 participants
INTERVENTIONAL
2021-07-30
2025-03-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo of SCD-044 product
Placebo tablet of SCD-044 product in subjects with moderate to severe atopic dermatitis.
Placebo
Placebo Tablet of SCD-044 product in subjects with moderate to severe atopic dermatitis.
SCD-044 Tablets_Dose 1
SCD-044 Tablets of low dose (Dose 1) in subjects with moderate to severe atopic dermatitis.
SCD-044_Dose 1
SCD-044 tablets of low dose (Dose 1) in subjects with moderate to severe atopic dermatitis.
SCD-044 Tablets_Dose 2
SCD-044 Tablets of intermediate dose (Dose 2) in subjects with moderate to severe atopic dermatitis.
SCD-044_Dose 2
SCD-044 tablets of intermediate dose (Dose 2) in subjects with moderate to severe atopic dermatitis.
SCD-044 Tablets_Dose 3
SCD-044 Tablets of high dose (Dose 3) in subjects with moderate to severe atopic dermatitis.
SCD-044_Dose 3
SCD-044 tablets of high dose (Dose 3) in subjects with moderate to severe atopic dermatitis.
Interventions
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Placebo
Placebo Tablet of SCD-044 product in subjects with moderate to severe atopic dermatitis.
SCD-044_Dose 1
SCD-044 tablets of low dose (Dose 1) in subjects with moderate to severe atopic dermatitis.
SCD-044_Dose 2
SCD-044 tablets of intermediate dose (Dose 2) in subjects with moderate to severe atopic dermatitis.
SCD-044_Dose 3
SCD-044 tablets of high dose (Dose 3) in subjects with moderate to severe atopic dermatitis.
Eligibility Criteria
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Inclusion Criteria
2. Males and non-pregnant non-lactating females, diagnosed with chronic atopic dermatitis for ≥ 1 year at Screening and Baseline based on Eichenfield revised criteria of Hanifin and Rajka.
3. Moderate to severe atopic dermatitis at Screening and Baseline
Exclusion Criteria
2. Known organ complications of Diabetes mellitus such as reduced renal function, significant retinal pathology or neuropathy.
3. History or presence of uveitis
\-
18 Years
ALL
No
Sponsors
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Sun Pharmaceutical Industries Limited
INDUSTRY
Responsible Party
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Locations
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Omni Dermatology
Phoenix, Arizona, United States
Yuma Clinical Trials, LLC
Yuma, Arizona, United States
T. Joseph Raoof Md, Imc./Encino Research Center
Encino, California, United States
Metropolis Dermatology
Los Angeles, California, United States
Axis Clinical Trials
Los Angeles, California, United States
Providence Clinical Research
North Hollywood, California, United States
Unison Clinical Trials
Sherman Oaks, California, United States
Providere' Research Inc.
West Covina, California, United States
Clarity Dermatology
Castle Rock, Colorado, United States
Accel Research Sites Network - Annexus Dermatology & Aestheitcs
DeLand, Florida, United States
Revival Research Corporation
Doral, Florida, United States
Advanced Clinical Research Institute
Florida City, Florida, United States
FXM Clinical Research Fort Lauderdale
Fort Lauderdale, Florida, United States
Direct Helpers Research Center
Hialeah, Florida, United States
Evolution Research Center
Hialeah, Florida, United States
Sweet Hope Research Specialty, Inc, d/b/a Neoclinical Research
Hialeah, Florida, United States
Evolution Clinical Trials, Inc
Hialeah Gardens, Florida, United States
Advanced Clinical Research Network, Corp
Miami, Florida, United States
MedOne Clinical Research, LLC
Miami, Florida, United States
Century Research LLC
Miami, Florida, United States
FXM Clinical Research Miami
Miami, Florida, United States
JD Medical Group, LLC
Miami, Florida, United States
FXM Clinical Research Miramar
Miramar, Florida, United States
Adtremed Inc
Tampa, Florida, United States
Alliance Clinical Research of Tampa
Tampa, Florida, United States
Oracle Clinical Research
College Park, Georgia, United States
Physicians Research Group
West Lafayette, Indiana, United States
Revival research Institute, LLC
Troy, Michigan, United States
DFW Clinical Research
Dallas, Texas, United States
3A Research
El Paso, Texas, United States
SMS Clinical Research
Mesquite, Texas, United States
Stride Clinical Research
Sugar Land, Texas, United States
Springville Dermatology/ CCT Research
Springville, Utah, United States
Skin DC Derm
Arlington, Virginia, United States
Clinica Vargas
San Salvador, , El Salvador
Clinica Dermatologica
San Salvador, , El Salvador
Clinica de Dermatologia y Cirugia de Piel
Santa Tecla, , El Salvador
Clinical Research Centre OU
Tartu, , Estonia
Malkhaz Katsiashvili Multiprofile Emergency Medicine Center LLC
Tbilisi, , Georgia
Israeli - Georgian Medical Research Clinic Healthycore LLC
Tbilisi, , Georgia
Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic LLC
Tbilisi, , Georgia
Emergency Cardiology Center by Academician G. Chapidze LLC
Tbilisi, , Georgia
LTD Aversi Clinic
Tbilisi, , Georgia
TIM - Tbilisi Institute of Medicine LLC
Tbilisi, , Georgia
David Abuladze Georgian-Italian Clinic LLC
Tbilisi, , Georgia
KLIMED
Bialystok, , Poland
Synexus Polska Sp. z o.o. Branch in Gdansk
Gdansk, , Poland
Dobry Lekarz' Modern Therapies Center Limited Liability Company
Krakow, , Poland
Landa Specialist Doctor's Offices
Krakow, , Poland
GLOBE Clinical Research
Kłodzko, , Poland
Appletreeclinics Clinical Research Centre
Lodz, , Poland
Dermedic Iwona Zdybska
Lublin, , Poland
EMC Medical Institute Joint Stock Company, "Certus" Private Healthcare Facility Hospital No. 1
Poznan, , Poland
TWOJA PRZYCHODNIA Medical Centre of Szczecin, Twoja Przychodnia SCM
Szczecin, , Poland
National Medical Institute of the MSWiA, Clinical Department of Dermatology
Warsaw, , Poland
Synexus Polska Sp. z o.o. Branch in Warsaw
Warsaw, , Poland
Military Institute of Medicine - National Research Institute, Department of Dermatology CWBK
Warsaw, , Poland
Synexus Polska Sp. z o.o. Branch in Wroclaw
Wroclaw, , Poland
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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SCD-044-19-16
Identifier Type: -
Identifier Source: org_study_id