A Study Evaluating the Safety and Efficacy of Topical BPR277 for the Treatment of Atopic Dermatitis and Netherton Syndrome
NCT01428297 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12
Last updated 2020-12-08
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
- DRUG
-
BPR277 ointment (controlled application)
- DRUG
-
Placebo (Vehicle)
- DRUG
-
BPR277 ointment
- DRUG
-
Placebo (Vehicle)
- DRUG
-
BPR277
- DRUG
-
Placebo (Vehicle)
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Novartis Pharmaceuticals · Novartis Pharmaceuticals
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2011-05-31
- Primary Completion
- 2014-02-28
- Completion
- 2014-02-28
Countries
- United States
- Netherlands
Study Locations
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