niclosamide topical (ATx 201) / UNION Therap - LARVOL DELTA

Topical niclosamide (ATx201) reduces Staphylococcus aureus colonization and increases Shannon diversity of the skin microbiome in atopic dermatitis patients in a randomized, double-blind, placebo-controlled Phase 2 trial. (PubMed, Clin Transl Med) - P1/2 | "These results suggest that ATx201 could become a new treatment modality as a decolonizing agent."

Clinical • Journal • P2 data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Infectious Disease

Study to Evaluate Safety & Efficacy of Topical ATx201 OINTMENT in Adolescents and Adults With Mild to Moderate AD (clinicaltrials.gov) - P2; N=220; Completed; Sponsor: UNION therapeutics; Recruiting ➔ Completed

Clinical • Trial completion • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Study to Evaluate Safety & Efficacy of Topical ATx201 OINTMENT in Adolescents and Adults With Mild to Moderate AD (clinicaltrials.gov) - P2; N=226; Recruiting; Sponsor: UNION therapeutics; Trial completion date: Sep 2020 ➔ Feb 2021; Trial primary completion date: Jun 2020 ➔ Oct 2020

Clinical • Trial completion date • Trial primary completion date • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

[VIRTUAL] ATx201 modulates biomarkers of skin barrier function and cutaneous inflammation in patients with moderate atopic dermatitis (SID 2020) - P2 | "IHC analysis further revealed that 15/29 (51.7%) subjects were classified as histological responders receiving ATx201 CREAM 2% versus 9/29 (31.0%) receiving vehicle. These data suggest that topical application of ATx201 is safe and improves biomarkers of skin barrier function and suppresses biomarkers of AD-associated inflammation across multiple T helper cell pathways."

Biomarker • Clinical • Atopic Dermatitis • Dermatitis • Dermatology • Dermatopathology • Immune Modulation • Immunology • Inflammation • CCL2 • CXCL1 • IL10 • IL13 • IL4R • S100A8 • S100A9 • STAT3

Study to Evaluate Safety & Efficacy of Topical ATx201 OINTMENT in Adolescents and Adults With Mild to Moderate AD (clinicaltrials.gov) - P2; N=226; Recruiting; Sponsor: UNION therapeutics

Clinical • New P2 trial

A Randomized, Double-Blind, Parallel Group, Vehicle-Controlled Phase 2 Study to Evaluate the Safety and Efficacy of Topical ATx201 OINTMENT in Adolescents and Adults with Mild to Moderate Atopic Dermatitis (clinicaltrialsregister.eu) - P2; N=226; Sponsor: UNION therapeutics A/S

Clinical • New P2 trial