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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.

Tracking Information
First Submitted Date  ICMJE April 21, 2015
First Posted Date  ICMJE April 24, 2015
Last Update Posted Date December 6, 2016
Study Start Date  ICMJE April 2015
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 8, 2016)
Percentage of patients who have the IGA score of 0 or 1 [ Time Frame: Week 8 ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 23, 2015)
Score Change from Baseline on SCORAD [ Time Frame: Weeks 2, 4, 6, and 8 ]
Change History Complete list of historical versions of study NCT02426359 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 8, 2016)
  • Percent change from baseline on the VAS for pruritus [ Time Frame: Week 8 ]
  • Percent change from baseline on the EASI [ Time Frame: Week 8 ]
  • Percent change from baseline on the SCORAD [ Time Frame: Week 8 ]
  • Percent change from baseline on the DLQI [ Time Frame: Week 8 ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy Study of Q301 in Moderate to Severe Atopic Dermatitis Patients
Official Title  ICMJE Not Provided
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Moderate to Severe Atopic Dermatitis
Intervention  ICMJE
  • Drug: Q301 Cream
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: Q301 Cream
    Q301 Cream
    Intervention: Drug: Q301 Cream
  • Placebo Comparator: Vehicle
    Vehicle
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 19, 2016)
57
Original Estimated Enrollment  ICMJE
 (submitted: April 23, 2015)
60
Actual Study Completion Date  ICMJE May 2016
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02426359
Other Study ID Numbers  ICMJE Q301-ADP2-US-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Qurient Co., Ltd.
Study Sponsor  ICMJE Qurient Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Qurient Co., Ltd.
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP