Safety and Efficacy Study of Q301 in Moderate to Severe Atopic Dermatitis Patients
Phase 2
Completed
- Conditions
- Moderate to Severe Atopic Dermatitis
- Interventions
- Drug: Q301 CreamDrug: Placebo
- Registration Number
- NCT02426359
- 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 adult subjects with moderate to severe AD. Study drug (Q301 Cream or vehicle) will be administered topically twice a day for 8 consecutive weeks.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 57
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Q301 Cream Q301 Cream Q301 Cream Vehicle Placebo Vehicle
- Primary Outcome Measures
Name Time Method Percentage of patients who have the IGA score of 0 or 1 Week 8
- Secondary Outcome Measures
Name Time Method 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 DLQI Week 8 Percent change from baseline on the SCORAD Week 8