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

Qurient

Status and phase: Completed; Phase 2

Conditions: Moderate to Severe Atopic Dermatitis

Treatments: Drug: Placebo; Drug: Q301 Cream

Study type: Interventional

Funder types: Industry

Identifiers

NCT02426359

Q301-ADP2-US-01

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

Enrollment: 57 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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57 participants in 2 patient groups, including a placebo group

Q301 Cream

Experimental group

Description:

Q301 Cream

Treatment:

Drug: Q301 Cream

Vehicle

Placebo Comparator group

Description:

Vehicle

Treatment:

Drug: Placebo