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Trial record 44 of 154 for:    Dermatitis, Atopic, 8

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03571620
Recruitment Status : Recruiting
First Posted : June 27, 2018
Last Update Posted : October 25, 2018
Sponsor:
Information provided by (Responsible Party):
Qurient Co., Ltd.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 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
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

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




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 ]


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.).

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


Contacts
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Contact: June Kim +82-31-80601610 jkim@qurient.com

Locations
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United States, North Carolina
Novella Recruiting
Morrisville, North Carolina, United States, 27560
Sponsors and Collaborators
Qurient Co., Ltd.

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Responsible Party: Qurient Co., Ltd.
ClinicalTrials.gov Identifier: NCT03571620     History of Changes
Other Study ID Numbers: Q301-AD-P2-US002
First Posted: June 27, 2018    Key Record Dates
Last Update Posted: October 25, 2018
Last Verified: October 2018

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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