Moderate to Severe Atopic Dermatitis
Conditions
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 adult subjects with moderate to severe AD. Study drug (Q301 Cream or vehicle) will be administered topically twice a day for 8 consecutive weeks.
Interventions
DRUGQ301 Cream
DRUGPlacebo
Sponsors
Qurient Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female subjects aged 18 or older 2. Subjects with a clinical diagnosis of AD according to the Hanifin and Rajka Criteria by a board certified/eligible dermatologist 3. Subjects with IGA score 3 or 4 corresponding to moderate to severe AD at screening and baseline visits
Exclusion criteria
1. Subjects who had topical treatment with corticosteroids within 1 week before randomization 2. Subjects who had systemic treatment with corticosteroids or cyclosporine or other immunosuppressive treatment within 4 weeks before randomization 3. Subjects who had ultraviolet irradiation (including photopheresis) within 4 weeks before screening 4. Subjects who participated in another drug trial within 4 weeks before screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients who have the IGA score of 0 or 1 | Week 8 |
Secondary
| Measure | Time frame |
|---|---|
| Percent change from baseline on the VAS for pruritus | Week 8 |
| Percent change from baseline on the EASI | Week 8 |
| Percent change from baseline on the SCORAD | Week 8 |
| Percent change from baseline on the DLQI | Week 8 |
Countries
United States
Outcome results
None listed