Safety and Efficacy Study of Q301 in Mild to Moderate Adolescents and Adults Atopic Dermatitis Patients
A Multicenter, Randomized, Phase 2, Double-blind, Vehicle-controlled, Parallel Group Comparison Study to Evaluate the Safety and Efficacy of Q301 Cream in Adolescents and Adults With Mild to Moderate Atopic Dermatitis
1 other identifier
interventional
258
1 country
1
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 adolescent and adult subjects with mild to moderate 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 P75+ for phase_2
Started Jun 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 20, 2018
CompletedStudy Start
First participant enrolled
June 21, 2018
CompletedFirst Posted
Study publicly available on registry
June 27, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 21, 2020
CompletedApril 24, 2020
April 1, 2020
1.4 years
June 20, 2018
April 21, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
proportion of patients with an IGA score of 0 (clear) or 1 (almost clear) and at least a two grade improvement in IGA score
Week 8
Study Arms (3)
Vehicle
PLACEBO COMPARATOR1.0% Q301 Cream
EXPERIMENTAL1.4% Q301 Cream
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Patient, for a period of at least three months, has had a clinical diagnosis of AD according to the Hanifin and Rajka Criteria by a board certified/eligible dermatologist.
- Patient has an Investigator's Global Assessment (IGA) score of 2 or 3 corresponding to mild or moderate AD
- Patient is in good general health and free of any disease state or physical condition that might impair evaluation of AD or which, in the investigator's opinion, exposes the patient to an unacceptable risk by study participation.
You may not qualify if:
- Patient has used within four weeks prior to randomization, systemic treatment with: 1) corticosteroids, 2) cyclosporine, 3) other immunosuppressive treatment or any medication known to affect AD (e.g., JAK inhibitors, etc.).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Wake Forest School of Medicine Department of Dermatology
Winston-Salem, North Carolina, 27104, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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
June 20, 2018
First Posted
June 27, 2018
Study Start
June 21, 2018
Primary Completion
November 30, 2019
Study Completion
April 21, 2020
Last Updated
April 24, 2020
Record last verified: 2020-04