Topically Applied AMTX-100 CF for Adult Patients With Mild to Moderate Atopic Dermatitis

Summary

This study determines the Maximum Tolerable Dose (MTD) by maximum BSA percentage treated and evaluates safety and efficacy of 1.1% w/w AMTX-100 CF versus placebo (vehicle). The study has two parts: Phase I (Part 1): Approximately Twenty-five (25) subjects with various treatable Body Surface Area (BSA) involvement of Mild to Moderate Atopic Dermatitis will be enrolled in the study and treated with 1.1% w/w AMTX-100 CF. Phase II (Part 2): Approximately sixty (60) subjects with Mild to Moderate Atopic Dermatitis with various treatable BSA involvement of Mild to Moderate Atopic Dermatitis will be randomized to be treated with 1.1% w/w AMTX-100 CF3 concentration or Vehicle (Placebo) in the study.

Timeline

Start

2020-03-10

Primary completion

2023-12-19

Completion

2024-01-02

Publications

• Liu Y, Qiao H, Zienkiewicz J, Hawiger J. Anti-inflammatory control of human skin keratinocytes by targeting nuclear transport checkpoint. Skin Health Dis. 2024 Mar 3;4(3):e356. doi: 10.1002/ski2.356. eCollection 2024 Jun.
• Liu Y, Zienkiewicz J, Qiao H, Gibson-Corley KN, Boyd KL, Veach RA, Hawiger J. Genomic control of inflammation in experimental atopic dermatitis. Sci Rep. 2022 Nov 7;12(1):18891. doi: 10.1038/s41598-022-23042-x.

Drugs

Indications