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

Sjögren-Larsson Syndrome Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02402309
• Other study ID #: NS-003
• Status: Completed
• Phase: Phase 2
• Start date: March 2015
• Est. completion date: June 2016

Study information

• Verified date: November 2022
• Source: Aldeyra Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: June 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ichthyosis
• Sjogren's Syndrome
• Sjogren-Larsson Syndrome
• Sjögren-Larsson Syndrome
• Syndrome

Intervention

Drug:
• Active topical NS2 1% dermatologic cream

• Vehicle placebo 0.0% NS2 dermatologic cream

Locations

Country	Name	City	State
United States	Pediatric and General Dermatology	Fairfax	Virginia
United States	Penn State Hershey Medical Center - Department of Dermatology	Hershey	Pennsylvania
United States	University of Nebraska Medical Center	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
Aldeyra Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Experiencing a Serious Adverse Event (SAE).		The safety assessment period is approximately 9 weeks.
Primary	Number of Participants Experiencing an Adverse Event Leading to Discontinuation.		The safety assessment period is approximately 9 weeks.