Safety and Efficacy Study of Q301 in Mild to Moderate Ado... | NCT03571620

Studies
Safety and Efficacy Study of Q301 in Mild to Moderate Adolescents and Adults Atopic Dermatitis Patients

NCT03571620

Sponsor

Qurient Co., Ltd.

Status

Completed

Last Update Posted

Apr 24, 2020Actual

Enrollment

258Actual

Phase

Phase 2

Conditions

Atopic Dermatitis

Interventions

Q301 Cream
Vehicle

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 21, 2018Actual

Primary Completion Date

Nov 30, 2019Actual

Completion Date

Apr 21, 2020Actual

First Submitted Date

Jun 20, 2018

First Submission Date that Met QC Criteria

Jun 20, 2018

First Posted Date

Jun 27, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 21, 2020

Last Update Posted Date

Apr 24, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

258Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Vehicle	Placebo Comparator	Drug: Vehicle
1.0% Q301 Cream	Experimental	Drug: Q301 Cream
1.4% Q301 Cream	Experimental	Drug: Q301 Cream

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Q301 Cream	Drug	1.0% or 1.4% Q301 Cream	1.0% Q301 Cream 1.4% Q301 Cream

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
proportion of patients with an IGA score of 0 (clear) or 1 (almost clear) and at least a two grade improvement in IGA score		Week 8

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

70 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Wake Forest School of Medicine Department of Dermatology		Winston-Salem	North Carolina	27104	United States

Condition Browse Module

MeSH Terms

ID	Term
D003876	Dermatitis, Atopic

Ancestor Terms

ID	Term
D012873	Skin Diseases, Genetic
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D003872	Dermatitis

Browse Leaves

Not provided

Browse Branches

Not provided