Clinical Trial: A Study of Topical NS2 Cream to Treat Ichthyosis in Sjögren-Larsson Syndrome (SLS)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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)

Brief Summary:

This is a multi-center, randomized, double-blind, vehicle-controlled, parallel-group study designed to evaluate the safety, 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.


Detailed Summary:
Sponsor: Aldeyra Therapeutics, Inc.

Current Primary Outcome: Number of Participants with Adverse Events as a measure of Safety and Tolerability [ Time Frame: Week 8 ]

As this is an early-stage safety, tolerability and exploratory activity study, no specific endpoint(s) are designated as primary or secondary.


Original Primary Outcome: Same as current

Current Secondary Outcome: Pharmacokinetics - Peak Plasma Concentration (Cmax) [ Time Frame: Day 1, Day 2, Week 4, Week 8 ]

Determination of single and repeat-dose PK profile of 1% NS2 topically administered to the skin.


Original Secondary Outcome: Same as current

Information By: Aldeyra Therapeutics, Inc.

Dates:
Date Received: March 17, 2015
Date Started: March 2015
Date Completion:
Last Updated: August 1, 2016
Last Verified: August 2016