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

Pediatric and General Dermatology

Fairfax, Virginia 22031

from

Fairfax, VA