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

Phase 2

Completed

• Conditions: Atopic Dermatitis
• Interventions: Drug: Vehicle; Drug: Q301 Cream

• Registration Number: NCT03571620
• Lead Sponsor: Qurient Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-06-20
• Study First Submitted QC: 2018-06-20
• Study Start: 2018-06-21
• Study First Posted: 2018-06-27
• Primary Completion: 2019-11-30
• Status Verified: 2020-04
• Study Completion: 2020-04-21
• Last Update Submitted: 2020-04-21
• Last Update Posted: 2020-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 258

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vehicle	Vehicle	-
1.0% Q301 Cream	Q301 Cream	-
1.4% Q301 Cream	Q301 Cream	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Wake Forest School of Medicine Department of Dermatology; 🇺🇸 Winston-Salem, North Carolina, United States