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Completed

NCT Number: NCT02426359

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

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.

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Key information

Conditions

Moderate to Severe Atopic Dermatitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Denver, Colorado, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Q301 Cream

Drug

Placebo

Drug

Primary outcomes

  1. Percentage of patients who have the IGA score of 0 or 1

    Time frame: Week 8

Secondary outcomes

  1. Percent change from baseline on the VAS for pruritus

    Time frame: Week 8

  2. Percent change from baseline on the EASI

    Time frame: Week 8

  3. Percent change from baseline on the SCORAD

    Time frame: Week 8

  4. Percent change from baseline on the DLQI

    Time frame: Week 8

Sponsors and collaborators

Lead sponsor

Qurient Co., Ltd.

Industry

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Apr 24, 2015
Registry last updated
Dec 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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