Phase 2
N=12
A Study of Topical NS2 Cream to Treat Ichthyosis in Sjögren-Larsson Syndrome (SLS)
Sjögren-Larsson Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT02402309 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Dec 2022
Primary outcome: Primary: Number of Participants Experiencing a Serious Adverse Event (SAE). — 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Active topical NS2 1% dermatologic cream (Drug); Vehicle placebo 0.0% NS2 dermatologic cream (Drug)
- Age
- Pediatric, Adult, Older Adult · 6+ yrs
- Sex
- All
- Sponsor
- Aldeyra Therapeutics, Inc.
- Primary completion
- May 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Experiencing a Serious Adverse Event (SAE). |
0; 0 | — |
| PRIMARY Number of Participants Experiencing an Adverse Event Leading to Discontinuation. |
0; 0 | — |
Summary
This 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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02402309). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.