A Study of Topical NS2 Cream to Treat Ichthyosis in Sjögren-Larsson Syndrome (SLS)
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ClinicalTrials.gov Identifier: NCT02402309 |
Recruitment Status :
Completed
First Posted : March 30, 2015
Results First Posted : December 13, 2022
Last Update Posted : December 13, 2022
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Sjögren-Larsson Syndrome | Drug: Active topical NS2 1% dermatologic cream Drug: Vehicle placebo 0.0% NS2 dermatologic cream | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 12 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
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) |
Study Start Date : | March 2015 |
Actual Primary Completion Date : | May 2016 |
Actual Study Completion Date : | June 2016 |

Arm | Intervention/treatment |
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Experimental: Active topical NS2 1% dermatologic cream
NS2 1% topical cream for dermal application
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Drug: Active topical NS2 1% dermatologic cream |
Placebo Comparator: Topical vehicle dermatologic
Vehicle placebo for dermal application
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Drug: Vehicle placebo 0.0% NS2 dermatologic cream |
- Number of Participants Experiencing a Serious Adverse Event (SAE). [ Time Frame: The safety assessment period is approximately 9 weeks. ]
- Number of Participants Experiencing an Adverse Event Leading to Discontinuation. [ Time Frame: The safety assessment period is approximately 9 weeks. ]

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Ages Eligible for Study: | 6 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02402309
United States, Nebraska | |
University of Nebraska Medical Center | |
Omaha, Nebraska, United States, 68198 | |
United States, Pennsylvania | |
Penn State Hershey Medical Center - Department of Dermatology | |
Hershey, Pennsylvania, United States, 17033 | |
United States, Virginia | |
Pediatric and General Dermatology | |
Fairfax, Virginia, United States, 22031 |
Principal Investigator: | William B. Rizzo, MD | University of Nebraska |
Responsible Party: | Aldeyra Therapeutics, Inc. |
ClinicalTrials.gov Identifier: | NCT02402309 |
Other Study ID Numbers: |
NS-003 |
First Posted: | March 30, 2015 Key Record Dates |
Results First Posted: | December 13, 2022 |
Last Update Posted: | December 13, 2022 |
Last Verified: | November 2022 |
Sjögren-Larsson Syndrome SLS FALDH Deficiency Neuro-ichthyosis Fatty Alcohol:NAD+ Oxidoreductase Deficiency |
Fatty Aldehyde Dehydrogenase Deficiency Disease Congenital Icthyosis Mental Retardation Spasticity Syndrome Spastic Neurologic Disorder Oligophrenia Ichthyosis |
Sjogren's Syndrome Ichthyosis Sjogren-Larsson Syndrome Syndrome Disease Pathologic Processes Arthritis, Rheumatoid Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Xerostomia Salivary Gland Diseases Mouth Diseases Stomatognathic Diseases |
Dry Eye Syndromes Lacrimal Apparatus Diseases Eye Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Skin Abnormalities Congenital Abnormalities Infant, Newborn, Diseases Keratosis Skin Diseases Lipidoses Lipid Metabolism, Inborn Errors Metabolism, Inborn Errors Genetic Diseases, Inborn |