NCT03824405

Study of the Safety, Tolerability and Efficacy of BTX 1204 in Patients With Moderate Atopic Dermatitis

A Randomized, Double-Blind, Vehicle-Controlled Study of the Safety, Tolerability and Efficacy of BTX 1204 in Patients With Moderate Atopic Dermatitis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Botanix Pharmaceuticals · Industry
• Sex: All
• Age: 12 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, double-blind, vehicle-controlled, Phase 2 study in subjects with moderate AD.

Detailed description

This is a randomized, double-blind, vehicle-controlled, Phase 2 study in subjects with moderate AD. Eligible subjects will be enrolled and randomized to treatment with BTX 1204 or Vehicle for 84 days. Approximately two hundred (200) subjects will be enrolled. Subjects will receive BID application of study drug for 84 days with a final application on the evening of Day 84 for a total of 168 doses.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	BTX 1204	BTX 1204 liquid formulation
DRUG	Vehicle	Vehicle liquid formulation

Timeline

• Start date: 2019-02-04
• Primary completion: 2020-01-27
• Completion: 2020-03-04
• First posted: 2019-01-31
• Last updated: 2022-10-25
• Results posted: 2022-09-27

Locations

31 sites across 3 countries: United States, Australia, New Zealand

Regulatory

• FDA-regulated drug study