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)

NCT02402309 Phase 2 COMPLETED Results posted

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.

Details

Lead sponsor	Aldeyra Therapeutics, Inc.
Phase	Phase 2
Status	COMPLETED
Enrolment	12
Start date	2015-03
Completion	2016-06

Conditions

• Sjögren-Larsson Syndrome

Interventions

• Active topical NS2 1% dermatologic cream
• Vehicle placebo 0.0% NS2 dermatologic cream

Primary outcomes

• Number of Participants Experiencing a Serious Adverse Event (SAE). — The safety assessment period is approximately 9 weeks.
• Number of Participants Experiencing an Adverse Event Leading to Discontinuation. — The safety assessment period is approximately 9 weeks.

Countries

United States