Safety and Efficacy Study of Q301 in Moderate to Severe Atopic Dermatitis Patients

Completed · Phase 2 · Has a placebo group

Conditions studied: Moderate to Severe 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 adult subjects with moderate to severe AD. Study drug (Q301 Cream or vehicle) will be administered topically twice a day for 8 consecutive weeks.

Key facts

Study ID: NCT02426359
Run by: Qurient Co., Ltd.
People needed: 57
Starts: 2015-04-01
Expected to finish: 2016-05-01
Last updated by the study team: 2016-12-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Male or female subjects aged 18 or older
Subjects with a clinical diagnosis of AD according to the Hanifin and Rajka Criteria by a board certified/eligible dermatologist
Subjects with IGA score 3 or 4 corresponding to moderate to severe AD at screening and baseline visits

You may not qualify if…

Subjects who had topical treatment with corticosteroids within 1 week before randomization
Subjects who had systemic treatment with corticosteroids or cyclosporine or other immunosuppressive treatment within 4 weeks before randomization
Subjects who had ultraviolet irradiation (including photopheresis) within 4 weeks before screening
Subjects who participated in another drug trial within 4 weeks before screening

Where it is running

Study site — Denver, Colorado, United States
Study site — Berlin, New Jersey, United States
Study site — East Windsor, New Jersey, United States
Study site — Buffalo, New York, United States
Study site — Winston-Salem, North Carolina, United States
Study site — Austin, Texas, United States
Study site — College Station, Texas, United States

Full record on ClinicalTrials.gov

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