Pharmacokinetics and Safety of MM36 Topical Ointment in Pediatric Subjects With Atopic Dermatitis
NCT ID: NCT02945657
Last Updated: 2018-11-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
32 participants
INTERVENTIONAL
2016-10-31
2017-06-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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MM36 1% ointment
MM36 topical ointment, 1%, applied twice daily for 28 days
MM36 topical ointment, 1%
Twice daily application for 28 consecutive days
Interventions
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MM36 topical ointment, 1%
Twice daily application for 28 consecutive days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of atopic dermatitis (AD)
* AD affecting ≥ 35% body surface area (BSA) if 2 to \< 12 years of age or ≥ 25% if subject is ≥ 12 years of age (excluding scalp and venous access areas)
Exclusion Criteria
* History of recurrent bacterial infection
* Malignancy
* Clinically significant history or physical findings that may pose a health risk to subject or may have an impact on study assessments
2 Years
17 Years
ALL
No
Sponsors
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Medimetriks Pharmaceuticals, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Noah Rosenberg, MD
Role: STUDY_DIRECTOR
Medimetriks Pharmaceuticals, Inc
Locations
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Medimetriks Investigational Site
Houston, Texas, United States
Medimetriks Investigational Site
Norfolk, Virginia, United States
Medimetriks Investigational Site
Spokane, Washington, United States
Medimetriks Investigational Site
San Pedro Sula, , Honduras
Medimetriks Investigational Site
Panama City, , Panama
Medimetriks Investigational Site
Fremont, California, United States
Medimetriks Investigational Site
Irvine, California, United States
Medimetriks Investigational Site
San Diego, California, United States
Medimetriks Investigational Site
Miami, Florida, United States
Medimetriks Investigational Site
Saint Joseph, Missouri, United States
Medimetriks Investigational Site
Portland, Oregon, United States
Medimetriks Investigational Site
Austin, Texas, United States
Countries
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Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Other Identifiers
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MEDI-MM36-206
Identifier Type: -
Identifier Source: org_study_id
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