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Completed Phase 1Phase 2 Interventional Results available

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

ClinicalTrials.gov ID: NCT04313400

Public ClinicalTrials.gov record NCT04313400. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 1:35 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT04313400
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1, Phase 2
Lead sponsor
Amytrx Therapeutics, Inc.
Industry
Enrollment
91 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 9, 2020
Primary completion
Dec 18, 2023
Completion
Jan 1, 2024
Last update posted
May 1, 2025

2020 – 2024

United States locations

U.S. sites
11
U.S. states
5
U.S. cities
11
Facility City State ZIP Site status
Amytrx Investigational site Cerritos California 90703
Amytrx Investigational site Encino California 91436
Amytrx Investigational site Long Beach California 90805
Amytrx Investigational site North Hollywood California 91606
Amytrx Investigational site San Diego California 92123
Amytrx Investigational site Sherman Oaks California 91403
Amytrx Investigational site Miami Florida 33175
Amytrx Investigational site Miramar Florida 33027
Amytrx Investigational site Troy Michigan 48084
Amytrx Investigational site New York New York 11415
Amytrx Investigational site Philadelphia Pennsylvania 19103

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04313400, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 1, 2025 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04313400 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →