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Trial record 1 of 2 for:    Q301
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Safety and Efficacy Study of Q301 in Mild to Moderate Adolescents and Adults Atopic Dermatitis Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03571620
Recruitment Status : Completed
First Posted : June 27, 2018
Last Update Posted : April 24, 2020
Sponsor:
Information provided by (Responsible Party):
Qurient Co., Ltd.

Study Description
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Brief Summary:
This is a randomized, double-blind, vehicle-controlled, parallel-group comparison study to evaluate the safety and efficacy of Q301 Cream vs. vehicle in adolescent and adult subjects with mild to moderate AD. Study drug (Q301 Cream or vehicle) will be administered topically twice a day for 8 consecutive weeks.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: Q301 Cream Drug: Vehicle Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 258 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Phase 2, Double-blind, Vehicle-controlled, Parallel Group Comparison Study to Evaluate the Safety and Efficacy of Q301 Cream in Adolescents and Adults With Mild to Moderate Atopic Dermatitis
Actual Study Start Date : June 21, 2018
Actual Primary Completion Date : November 30, 2019
Actual Study Completion Date : April 21, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Vehicle Drug: Vehicle
Vehicle Control
Experimental: 1.0% Q301 Cream Drug: Q301 Cream
1.0% or 1.4% Q301 Cream
Experimental: 1.4% Q301 Cream Drug: Q301 Cream
1.0% or 1.4% Q301 Cream


Outcome Measures
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Primary Outcome Measures :
  1. proportion of patients with an IGA score of 0 (clear) or 1 (almost clear) and at least a two grade improvement in IGA score [ Time Frame: Week 8 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient, for a period of at least three months, has had a clinical diagnosis of AD according to the Hanifin and Rajka Criteria by a board certified/eligible dermatologist.
  • Patient has an Investigator's Global Assessment (IGA) score of 2 or 3 corresponding to mild or moderate AD
  • Patient is in good general health and free of any disease state or physical condition that might impair evaluation of AD or which, in the investigator's opinion, exposes the patient to an unacceptable risk by study participation.

Exclusion Criteria:

  • Patient has used within four weeks prior to randomization, systemic treatment with: 1) corticosteroids, 2) cyclosporine, 3) other immunosuppressive treatment or any medication known to affect AD (e.g., JAK inhibitors, etc.).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03571620


Locations
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United States, North Carolina
Wake Forest School of Medicine Department of Dermatology
Winston-Salem, North Carolina, United States, 27104
Sponsors and Collaborators
Qurient Co., Ltd.
More Information
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Responsible Party: Qurient Co., Ltd.
ClinicalTrials.gov Identifier: NCT03571620    
Other Study ID Numbers: Q301-AD-P2-US002
First Posted: June 27, 2018    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
 Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases