Title
A Study of Topical NS2 Cream to Treat Ichthyosis in Sjögren-Larsson Syndrome (SLS)
Phase II Study of the Safety, Pharmacokinetics, and Exploratory Activity of Once Daily (QD) Topical Application of NS2 Cream to Treat Ichthyosis in Subjects With Sjögren-Larsson Syndrome (SLS)
Phase
Phase 2Lead Sponsor
Aldeyra Therapeutics, Inc.Study Type
InterventionalStatus
Completed Results PostedIndication/Condition
Sjögren-Larsson SyndromeIntervention/Treatment
adx-102 ...Study Participants
12This is a multi-center, randomized, double-blind, vehicle-controlled, parallel-group study designed to evaluate the safety, pharmacokinetic (PK), and exploratory activity of topically-applied NS2 dermatologic cream administered once-daily (QD) to subjects with ichthyosis secondary to Sjögren- Larsson Syndrome (SLS).
NS2 is expected to trap fatty aldehydes that are pathogenic in SLS patients, and thereby diminish the lipid-aldehyde adduct formation that likely results in ichthyosis associated with SLS, and potentially reduce the mild dermal inflammation characteristic of SLS.
NS2 1% topical cream for dermal application
Vehicle placebo for dermal application
Inclusion Criteria: Genetically-confirmed diagnosis of SLS Active ichthyosis on the lower extremities that is determined to be at least moderate severity Exclusion Criteria: Evidence of an active infection Currently receiving immunosuppressive therapy, including intermittent or low-dose corticosteroids and is not able or willing to suspend from 2 weeks before and during the study Currently receiving systemic or topical retinoids, other topically applied drugs, or other supplements that could interfere with dermatologic examination findings Received an investigational systemic or topically administered drug within 30 days before screening
| Event Type | Organ System | Event Term | Topical NS2 1% Dermatologic Cream | Topical Vehicle Dermatologic |
|---|
