At a glance
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A Two Part, Phase I/II, Multi-Center, Double-Blind, Randomized, Vehicle-Controlled Study of the Safety and Efficacy of Topically Applied AMTX-100 CF in Adult Patients With Mild to Moderate Atopic Dermatitis
In Brief
A Phase 2 clinical trial evaluating 1.1% w/w AMTX-100 CF-part1, Placebo, and 1 other intervention for Atopic Dermatitis. Completed, enrolled 91 participants across 11 sites.
Detailed 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.
Study Details
Timeline
Interventions
AMTX-100 CF, topical cream with 1.1% w/w active pharmaceutical ingredient
Topical cream manufactured to mimic AMTX-100 CF3
AMTX-100 CF3, topical cream with 1.1% w/w active pharmaceutical ingredient