Safety and Efficacy Study of Q301 in Moderate to Severe Atopic Dermatitis Patients
1 other identifier
interventional
57
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Apr 2015
Shorter than P25 for phase_2
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2015
CompletedFirst Submitted
Initial submission to the registry
April 21, 2015
CompletedFirst Posted
Study publicly available on registry
April 24, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedDecember 6, 2016
May 1, 2016
9 months
April 21, 2015
December 3, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of patients who have the IGA score of 0 or 1
Week 8
Secondary Outcomes (4)
Percent change from baseline on the VAS for pruritus
Week 8
Percent change from baseline on the EASI
Week 8
Percent change from baseline on the SCORAD
Week 8
Percent change from baseline on the DLQI
Week 8
Study Arms (2)
Q301 Cream
EXPERIMENTALQ301 Cream
Vehicle
PLACEBO COMPARATORVehicle
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Unknown Facility
Denver, Colorado, 80220, United States
Unknown Facility
Berlin, New Jersey, 08009, United States
Unknown Facility
East Windsor, New Jersey, 08520, United States
Unknown Facility
Buffalo, New York, 14203, United States
Unknown Facility
Winston-Salem, North Carolina, 27157, United States
Unknown Facility
Austin, Texas, 78759, United States
Unknown Facility
College Station, Texas, 77845, United States
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 21, 2015
First Posted
April 24, 2015
Study Start
April 1, 2015
Primary Completion
January 1, 2016
Study Completion
May 1, 2016
Last Updated
December 6, 2016
Record last verified: 2016-05