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

December 3, 2016 updated by: Qurient Co., Ltd.
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

57

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States, 80220
    • New Jersey
      • Berlin, New Jersey, United States, 08009
      • East Windsor, New Jersey, United States, 08520
    • New York
      • Buffalo, New York, United States, 14203
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
    • Texas
      • Austin, Texas, United States, 78759
      • College Station, Texas, United States, 77845

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Vehicle
Drug: Placebo
Experimental: Q301 Cream
Drug: Q301 Cream

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients who have the IGA score of 0 or 1
Time Frame: Week 8
Week 8

Secondary Outcome Measures

Outcome Measure
Time Frame
Percent change from baseline on the VAS for pruritus
Time Frame: Week 8
Week 8
Percent change from baseline on the EASI
Time Frame: Week 8
Week 8
Percent change from baseline on the SCORAD
Time Frame: Week 8
Week 8
Percent change from baseline on the DLQI
Time Frame: Week 8
Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qurient Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

April 21, 2015

First Submitted That Met QC Criteria

April 23, 2015

First Posted (Estimate)

April 24, 2015

Study Record Updates

Last Update Posted (Estimate)

December 6, 2016

Last Update Submitted That Met QC Criteria

December 3, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Q301-ADP2-US-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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