CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 12 enrolled
Drug / intervention
Active topical NS2 1% dermatologic cream +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02402309
NCT02402309Phase 2Completed

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)

Aldeyra Therapeutics, Inc.·interventional·Posted Mar 30, 2015·Updated Dec 13, 2022

In Brief

A Phase 2 clinical trial evaluating Active topical NS2 1% dermatologic cream and Vehicle placebo 0.0% NS2 dermatologic cream for Sjögren-Larsson Syndrome. Completed, enrolled 12 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMar 30, 2015
Enrollment StartMar 1, 2015
Primary CompletionMay 1, 2016
Study CompletionJun 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 11.3 years ago

Interventions

Active topical NS2 1% dermatologic creamdrug

Vehicle placebo 0.0% NS2 dermatologic creamdrug