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Completed

NCT Number: NCT03571620

Safety and Efficacy Study of Q301 in Mild to Moderate Adolescents and Adults 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 adolescent and adult subjects with mild to moderate 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

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

12 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Wake Forest School of Medicine Department of Dermatology

Winston-Salem, North Carolina, 27104, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient, for a period of at least three months, has had a clinical diagnosis of AD according to the Hanifin and Rajka Criteria by a board certified/eligible dermatologist.
  • Patient has an Investigator's Global Assessment (IGA) score of 2 or 3 corresponding to mild or moderate AD
  • Patient is in good general health and free of any disease state or physical condition that might impair evaluation of AD or which, in the investigator's opinion, exposes the patient to an unacceptable risk by study participation.

Exclusion criteria

  • Patient has used within four weeks prior to randomization, systemic treatment with: 1) corticosteroids, 2) cyclosporine, 3) other immunosuppressive treatment or any medication known to affect AD (e.g., JAK inhibitors, etc.).

Treatment and study plan

Q301 Cream

Drug

1.0% or 1.4% Q301 Cream

Vehicle

Drug

Vehicle Control

Primary outcomes

  1. proportion of patients with an IGA score of 0 (clear) or 1 (almost clear) and at least a two grade improvement in IGA score

    Time frame: Week 8

Sponsors and collaborators

Lead sponsor

Qurient Co., Ltd.

Industry

Registry information

Official study title

A Multicenter, Randomized, Phase 2, Double-blind, Vehicle-controlled, Parallel Group Comparison Study to Evaluate the Safety and Efficacy of Q301 Cream in Adolescents and Adults With Mild to Moderate Atopic Dermatitis

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Jun 27, 2018
Registry last updated
Apr 24, 2020

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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