Trial | NCT02426359  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    q301 ...

  • Study Participants

    57
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.
Study Started
Apr 30
2015
Primary Completion
Jan 31
2016
Study Completion
May 31
2016
Last Update
Dec 06
2016
Estimate

Drug Q301 Cream

Drug Placebo

Q301 Cream Experimental

Q301 Cream

Vehicle Placebo Comparator

Vehicle

Criteria 

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
No Results Posted