A first-in-human study to evaluate safety and tolerability of repeated topical administrations of BPR277 ointment in healthy volunteers, and safety, tolerability, and preliminary efficacy of multiple topical administrations of BPR277 in patients with atopic dermatitis and Netherton syndrome (CBPR277X2101)
- Conditions
- Netherton syndrome10040790
- Registration Number
- NL-OMON40034
- Lead Sponsor
- ovartis Pharma BV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 5
• Male and female patients with Netherton syndrome, 18 to 65 years of age inclusive.
• Confirmed diagnosis of Netherton syndrome (SPINK5 mutation and/or LEKTI deficiency in the skin).
• Total lesional sign score NS (TLSS-NS) of 5-9 for each selected treatment area at baseline.
• Each treatment area must have a minimum of approximately 250 cm2 of lesional skin within a maximum of approximately 1500 cm2. The TLSS-NS values of both treatment areas need to be similar and, if possible, should not differ (±) by more than 1 point between the two areas at baseline.
• History of abnormal skin reactivity to UV light. Unusual exposure to UV light in the previous 3 weeks to study start (screening), including tanning and sun beds.
• Pregnant or nursing (lactating) women.
• Women of child-bearing potential not using acceptable contraceptive methods.
• Recent previous treatment with phototherapy, biological therapy, immunosuppressive agents (see protocol page 62 for details).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Total lesional sign score</p><br>
- Secondary Outcome Measures
Name Time Method <p>Lesional itch VAS, investigator and patient global assessment, safety.</p><br>