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

Qurient

Status and phase

Completed

Phase 2

Conditions

Atopic Dermatitis

Treatments

Drug: Q301 Cream

Drug: Vehicle

Study type

Interventional

Funder types

Industry

Identifiers

NCT03571620

Q301-AD-P2-US002

Details and patient eligibility

About

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.

Enrollment

258 patients

Sex

All

Ages

12 to 70 years old

Volunteers

No Healthy Volunteers

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.).