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

Completed · Phase 2

Conditions studied: Atopic Dermatitis

In brief

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.

Key facts

Study ID

NCT03571620

Run by

Qurient Co., Ltd.

People needed

258

Starts

2018-06-21

Expected to finish

2020-04-21

Last updated by the study team

2020-04-24

Who can join

Age: 12 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

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.).

Where it is running

• Wake Forest School of Medicine Department of Dermatology — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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