NCT03573518

Evaluation of BTX 1503 in Patients With Moderate to Severe Acne Vulgaris

A Randomized, Double-Blind, Vehicle-Controlled Study to Evaluate the Safety and Efficacy of BTX 1503 in Patients With Moderate to Severe Acne Vulgaris

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 368 (actual)
• Sponsor: Botanix Pharmaceuticals · Industry
• Sex: All
• Age: 12 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to assess safety and efficacy of various doses of BTX 1503 liquid formulation in subjects with moderate to severe acne vulgaris of the face.

Detailed description

This will be a multi-center, randomized, double-blinded, vehicle-controlled, parallel group, dose-finding study in pediatrics, adolescents and adults (aged 12 to 40 years). The objective of this study is to assess the safety and efficacy of various doses of BTX 1503 in subjects with moderate to severe acne vulgaris of the face.

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
DRUG	BTX 1503	BTX 1503 Dose 1 liquid formulation, or BTX 1503 Dose 2 liquid formulation
DRUG	Vehicle	Placebo

Timeline

• Start date: 2018-06-26
• Primary completion: 2019-08-16
• Completion: 2019-09-05
• First posted: 2018-06-29
• Last updated: 2022-04-18
• Results posted: 2022-04-18

Locations

36 sites across 2 countries: United States, Australia

Regulatory

• FDA-regulated drug study