Clinical Trial: A Study Evaluating the Safety and Efficacy of Topical BPR277 for the Treatment of Atopic Dermatitis and Netherton Syndrome
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: 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 BPR
Brief 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).
Detailed Summary:
Sponsor: Novartis Pharmaceuticals
Current Primary Outcome:
- Systemic and local tolerability of BPR277 ointment, as measured by change in local tolerability score, number of adverse events and clinically significant changes in standard hematology, blood chemistry. [ Time Frame: 2-4 weeks ]
- Part 2 and 3: Patients with Atopic Dermatitis / Netherton syndrome: Change in Total Lesional Signs Score at the treated skin area [ Time Frame: 4 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Part 2 and 3: Patients with Atopic Dermatitis / Netherton syndrome: Change for each sign comprising the total lesional signs score at the treated skin area [ Time Frame: 4 weeks ]
Original Secondary Outcome: Same as current
Information By: Novartis
Dates:
Date Received: August 19, 2011
Date Started: May 2011
Date Completion:
Last Updated: February 2, 2015
Last Verified: February 2015
