Efficacy and Safety of PR022 Topical Gel to Treat Mild-to-Moderate Atopic Dermatitis
NCT ID: NCT03351777
Last Updated: 2017-12-21
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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UNKNOWN
PHASE2
120 participants
INTERVENTIONAL
2017-12-04
2018-07-31
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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PR022 topical gel, 0.05%
Applied twice daily for 28 days
PR022
Topical Gel
PR022 topical gel, 0.1%
Applied twice daily for 28 days
PR022
Topical Gel
PR022 topical gel vehicle
Applied twice daily for 28 days
PR022
Topical Gel
Interventions
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PR022
Topical Gel
Eligibility Criteria
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Inclusion Criteria
* EASI score ≤ 21 at baseline
* Diagnosis of mild-to-moderate (grade 2 or 3) AD according to the ISGA scale at Baseline
* BSA affected by AD: 5% to 20% at start of treatment
* Willing and able to apply study treatments as directed, comply with study instructions, and commit to attending all visits
* Willing and able to provide informed consent
* Use of adequate birth control, if of reproductive potential and sexually active
Exclusion Criteria
* Use of any of the following treatments within the specified time periods prior to Day 1
* Topical medications (topical antibiotics, topical corticosteroids, topical antifungals, topical antihistamines, topical retinoids, topical calcipotriene, tacrolimus, pimecrolimus, or other topical drug products for treatment of AD) or bleach bath within 2 weeks prior to Day 1
* Systemic agents (cyclosporine, systemic corticosteroids \[oral and injectable; intranasal and inhaled corticosteroids are allowed if use is kept constant during the study\], systemic antibiotics, immunomodulators or immunosuppressive therapies, interferon, cytotoxic drugs \[e.g., methotrexate, cyclophosphamide, azathioprine\], oral retinoids, systemic antifungals, tacrolimus) for the treatment of AD within 4 weeks prior to Day 1
* Ultraviolet (UV) therapy or use of a tanning booth/parlor within 6 weeks prior to Day 1
* Biologic therapies within 12 weeks (or 5 half-lives) prior to Day 1
* Antihistamines within 5 days prior to Day 1 \[stable regimens (consistent use ≥ 14 days before Day 1) of oral H1 antihistamines for non-AD lesion treatment will be allowed\]
* Active or potentially recurrent dermatologic condition other than AD that may confound evaluation
* Congenital ichthyosis (note that subjects with ichthyosis vulgaris are permitted)
* Known allergy to any ingredients of the investigational product formulation
* Significant confounding conditions as assessed by Investigator
* Any condition that could interfere with any evaluation in the study
* Pregnancy or breast feeding
* Any reason which, in the opinion of the Investigator, interferes with the ability of the subject to participate in or complete the trial
18 Years
65 Years
ALL
No
Sponsors
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Realm Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Christian Peters, MD, PhD
Role: STUDY_DIRECTOR
Realm
Locations
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Principal Investigator
Philadelphia, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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Principal Investigator
Role: primary
Other Identifiers
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REALM-1
Identifier Type: -
Identifier Source: org_study_id