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

Status:	Completed
Conditions:	Dermatology, Rheumatology
Therapuetic Areas:	Dermatology / Plastic Surgery, Rheumatology
Healthy:	No
Age Range:	6 - Any
Updated:	3/20/2019
Start Date:	March 2015
End Date:	June 2016

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)

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.

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

We found this trial at

sites

Penn State Hershey Medical Center Department of Dermatology

Hershey, Pennsylvania 17033

Principal Investigator: Andrea Zaenglein, MD

Phone: 717-531-1513

from

Hershey, PA