Study Results
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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COMPLETED
PHASE1
28 participants
INTERVENTIONAL
2020-02-27
2021-05-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
Enrollment started with Healthy Subjects in Feb 2020. The protocol was amended Jul 2020 to include Atopic Dermatitis (AD) Subjects (Part B).
TREATMENT
NONE
Study Groups
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Healthy Subjects (Part A)
CEE321 0.2% (3 mg/cm2) topical cream b.i.d.
CEE321
CEE321 administered to all subjects
Atopic Dermatitis (Part B)
CEE321 0.2% (3 mg/cm2) topical cream b.i.d.
CEE321
CEE321 administered to all subjects
Interventions
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CEE321
CEE321 administered to all subjects
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Able to communicate well with the investigator to understand and comply with the requirements of the study, including skin biopsies
* Healthy male and female subjects aged ≥18 and ≤ 65 years
* Able to comply with requirement of domiciliation at the investigational site
* Written informed consent
* Able to communicate well with the investigator to understand and comply with the requirements of the study, including skin biopsies
* Adult male or female subjects aged ≥18 and ≤ 65 years with confirmed clinical diagnosis of atopic dermatitis (AD)
Exclusion Criteria
* Any infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals and/or hospitalization, isolation, quarantine within 4 weeks prior to first treatment
* Women of childbearing potential defined as all women physiologically capable of becoming pregnant.
* History of drug or alcohol abuse within the 12 months prior to dosing
* Subjects with a history of hypertrophic scars or keloids.
* Any infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals and/or hospitalization, isolation, quarantine within 4 weeks prior to first treatment
* Women of childbearing potential defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception
* History of drug or alcohol abuse within the 3 months prior to dosing
* Any skin disease that, in the opinion of the investigator, would confound the diagnosis or evaluation of AD disease activity
* Clinical significant medical condition, including psychiatric condition, which in the Investigator's opinion may interfere with safety of subjects, study objectives or adherence to the protocol.
18 Years
65 Years
ALL
Yes
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Novartis Investigative Site
Glendale, California, United States
Novartis Investigative Site
Baltimore, Maryland, United States
Novartis Investigative Site
Hachiōji, Tokyo, Japan
Countries
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Related Links
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Other Identifiers
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jRCT2031200317
Identifier Type: OTHER
Identifier Source: secondary_id
CCEE321A12101
Identifier Type: -
Identifier Source: org_study_id
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