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NCT03571620 Clinical Trial

Safety and Efficacy Study of Q301 in Mild to Moderate Adolescents and Adults Atopic Dermatitis Patients

Atopic Dermatitis Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03571620
Other study ID # Q301-AD-P2-US002
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date June 21, 2018
Est. completion date April 21, 2020

Study information
Verified date April 2020
Source Qurient Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 258
Est. completion date April 21, 2020
Est. primary completion date November 30, 2019
Accepts healthy volunteers No
Gender All
Age group 12 Years to 70 Years
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.).

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Q301 Cream
1.0% or 1.4% Q301 Cream
• Vehicle
Vehicle Control

Locations
Country Name City State
United States Wake Forest School of Medicine Department of Dermatology Winston-Salem North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Qurient Co., Ltd.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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