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

Moderate to Severe Atopic Dermatitis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02426359
• Other study ID #: Q301-ADP2-US-01
• Status: Completed
• Phase: Phase 2
• First received: April 21, 2015
• Last updated: December 3, 2016
• Start date: April 2015
• Est. completion date: May 2016

Study information

• Verified date: May 2016
• Source: Qurient Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: May 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Atopic
• Eczema
• Moderate to Severe Atopic Dermatitis

Intervention

Drug:
• Q301 Cream

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Qurient Co., Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients who have the IGA score of 0 or 1		Week 8	No
Secondary	Percent change from baseline on the VAS for pruritus		Week 8	No
Secondary	Percent change from baseline on the EASI		Week 8	No
Secondary	Percent change from baseline on the SCORAD		Week 8	No
Secondary	Percent change from baseline on the DLQI		Week 8	No