NCT01428297

A Study Evaluating the Safety and Efficacy of Topical BPR277 for the Treatment of Atopic Dermatitis and Netherton Syndrome

A First-In-human Study to Evaluate Safety and Tolerability of Topical BPR277 in Healthy Volunteers, and Proof of Concept (PoC) Studies to Evaluate the Safety, Tolerability, and Efficacy of Topical BPR277 in Patients With Atopic Dermatitis and Netherton Syndrome

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The study is divided in 3 parts, starting with the safety assessment of BPR277 ointment in Healthy volunteers (Part 1). If found to be well tolerated in Part 1, BPR277 ointment will be assessed in two different patients groups to evaluate safety and efficacy in atopic dermatitis (Part 2) and in Netherton syndrome (Part 3).

Conditions

• Healthy Volunteers
• Atopic Dermatitis
• Netherton Syndrome

Interventions

Type	Name	Description
DRUG	BPR277 ointment (controlled application)
DRUG	Placebo (Vehicle)
DRUG	BPR277 ointment
DRUG	Placebo (Vehicle)
DRUG	BPR277
DRUG	Placebo (Vehicle)

Timeline

• Start date: 2011-05-01
• Primary completion: 2014-02-01
• Completion: 2014-02-01
• First posted: 2011-09-02
• Last updated: 2020-12-08

Locations

4 sites across 2 countries: United States, Netherlands