Back to results

Safety and Efficacy Study of Q301 in Moderate to Severe Atopic Dermatitis Patients

Primary Purpose

Moderate to Severe Atopic Dermatitis

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Q301 Cream

Placebo

About this trial

This is an interventional treatment trial for Moderate to Severe Atopic Dermatitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female subjects aged 18 or older
Subjects with a clinical diagnosis of AD according to the Hanifin and Rajka Criteria by a board certified/eligible dermatologist
Subjects with IGA score 3 or 4 corresponding to moderate to severe AD at screening and baseline visits

Exclusion Criteria:

Subjects who had topical treatment with corticosteroids within 1 week before randomization
Subjects who had systemic treatment with corticosteroids or cyclosporine or other immunosuppressive treatment within 4 weeks before randomization
Subjects who had ultraviolet irradiation (including photopheresis) within 4 weeks before screening
Subjects who participated in another drug trial within 4 weeks before screening

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Q301 Cream

Vehicle

Arm Description

Q301 Cream

Vehicle

Outcomes

Primary Outcome Measures

Percentage of patients who have the IGA score of 0 or 1

Secondary Outcome Measures

Percent change from baseline on the VAS for pruritus

Percent change from baseline on the EASI

Percent change from baseline on the SCORAD

Percent change from baseline on the DLQI

Full Information

NCT ID

NCT02426359

First Posted

April 21, 2015

Last Updated

December 3, 2016

Sponsor

Qurient Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT02426359

Brief Title

Safety and Efficacy Study of Q301 in Moderate to Severe Atopic Dermatitis Patients

Study Type

Interventional

2. Study Status

Record Verification Date

May 2016

Overall Recruitment Status

Completed

Study Start Date

April 2015 (undefined)

Primary Completion Date

January 2016 (Actual)

Study Completion Date

May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Qurient Co., Ltd.

4. Oversight

Data Monitoring Committee

5. Study Description

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 adult subjects with moderate to severe AD. Study drug (Q301 Cream or vehicle) will be administered topically twice a day for 8 consecutive weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Moderate to Severe Atopic Dermatitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

57 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Q301 Cream

Arm Type

Experimental

Arm Description

Q301 Cream

Arm Title

Vehicle

Arm Type

Placebo Comparator

Arm Description

Vehicle

Intervention Type

Drug

Intervention Name(s)

Q301 Cream

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Percentage of patients who have the IGA score of 0 or 1

Time Frame

Week 8

Secondary Outcome Measure Information:

Title

Percent change from baseline on the VAS for pruritus

Time Frame

Week 8

Title

Percent change from baseline on the EASI

Time Frame

Week 8

Title

Percent change from baseline on the SCORAD

Time Frame

Week 8

Title

Percent change from baseline on the DLQI

Time Frame

Week 8

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female subjects aged 18 or older Subjects with a clinical diagnosis of AD according to the Hanifin and Rajka Criteria by a board certified/eligible dermatologist Subjects with IGA score 3 or 4 corresponding to moderate to severe AD at screening and baseline visits Exclusion Criteria: Subjects who had topical treatment with corticosteroids within 1 week before randomization Subjects who had systemic treatment with corticosteroids or cyclosporine or other immunosuppressive treatment within 4 weeks before randomization Subjects who had ultraviolet irradiation (including photopheresis) within 4 weeks before screening Subjects who participated in another drug trial within 4 weeks before screening

Facility Information:

City

Denver

State/Province

Colorado

ZIP/Postal Code

80220

Country

United States

City

Berlin

State/Province

New Jersey

ZIP/Postal Code

08009

Country

United States

City

East Windsor

State/Province

New Jersey

ZIP/Postal Code

08520

Country

United States

City

Buffalo

State/Province

New York

ZIP/Postal Code

14203

Country

United States

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27157

Country

United States

City

Austin

State/Province

Texas

ZIP/Postal Code

78759

Country

United States

City

College Station

State/Province

Texas

ZIP/Postal Code

77845

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Safety and Efficacy Study of Q301 in Moderate to Severe Atopic Dermatitis Patients

We'll reach out to this number within 24 hrs