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A Study of Topical NS2 Cream to Treat Ichthyosis in Sjögren-Larsson Syndrome (SLS)
NCT02402309 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DRUG Active topical NS2 1% dermatologic cream
- DRUG Vehicle placebo 0.0% NS2 dermatologic cream
Study Locations (3)
Nebraska
- University of Nebraska Medical Center — Omaha
Pennsylvania
- Penn State Hershey Medical Center - Department of Dermatology — Hershey
Virginia
- Pediatric and General Dermatology — Fairfax
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2015-03 |
| Est. Completion | 2016-06 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02402309
The ClinicalTrials.gov registry entry for NCT02402309 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Aldeyra Therapeutics, which has 5 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Sjögren-Larsson Syndrome appearing as the primary indexed condition, and to 2 interventions — of which Active topical NS2 1% dermatologic cream is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02402309 reports 3 study locations spanning 3 distinct geographic areas — top geographies include Nebraska, Pennsylvania, Virginia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT02402309 about?
NCT02402309 is a clinical study titled "A Study of Topical NS2 Cream to Treat Ichthyosis in Sjögren-Larsson Syndrome (SLS)". 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- Larsso...
What is the current status of trial NCT02402309?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2015-03. Estimated completion is 2016-06.
What conditions does trial NCT02402309 study?
This clinical trial studies the following conditions: Sjögren-Larsson Syndrome. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02402309?
The interventions under investigation include: Active topical NS2 1% dermatologic cream (DRUG), Vehicle placebo 0.0% NS2 dermatologic cream (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02402309?
This trial is sponsored by Aldeyra Therapeutics, which has 5 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02402309 being conducted?
This trial has 3 study locations across Nebraska, Pennsylvania, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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