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Trial record 2 of 2 for:    Q301

Safety and Efficacy Study of Q301 in Moderate to Severe 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: NCT02426359
Recruitment Status : Completed
First Posted : April 24, 2015
Last Update Posted : December 6, 2016
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 adult subjects with moderate to severe AD. Study drug (Q301 Cream or vehicle) will be administered topically twice a day for 8 consecutive weeks.

Condition or disease Intervention/treatment Phase
Moderate to Severe Atopic Dermatitis Drug: Q301 Cream Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : April 2015
Actual Primary Completion Date : January 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Q301 Cream
Q301 Cream
Drug: Q301 Cream
Placebo Comparator: Vehicle
Vehicle
Drug: Placebo



Primary Outcome Measures :
  1. Percentage of patients who have the IGA score of 0 or 1 [ Time Frame: Week 8 ]

Secondary Outcome Measures :
  1. Percent change from baseline on the VAS for pruritus [ Time Frame: Week 8 ]
  2. Percent change from baseline on the EASI [ Time Frame: Week 8 ]
  3. Percent change from baseline on the SCORAD [ Time Frame: Week 8 ]
  4. Percent change from baseline on the DLQI [ Time Frame: Week 8 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02426359


Locations
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United States, Colorado
Denver, Colorado, United States, 80220
United States, New Jersey
Berlin, New Jersey, United States, 08009
East Windsor, New Jersey, United States, 08520
United States, New York
Buffalo, New York, United States, 14203
United States, North Carolina
Winston-Salem, North Carolina, United States, 27157
United States, Texas
Austin, Texas, United States, 78759
College Station, Texas, United States, 77845
Sponsors and Collaborators
Qurient Co., Ltd.

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Responsible Party: Qurient Co., Ltd.
ClinicalTrials.gov Identifier: NCT02426359     History of Changes
Other Study ID Numbers: Q301-ADP2-US-01
First Posted: April 24, 2015    Key Record Dates
Last Update Posted: December 6, 2016
Last Verified: May 2016

Additional relevant MeSH terms:
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Dermatitis
Dermatitis, Atopic
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases