CompletedNCT02402309Updated Dec 13, 2022Results posted

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

A Phase 2 interventional study of Active topical NS2 1% dermatologic cream and Vehicle placebo 0.0% NS2 dermatologic cream in Sjögren-Larsson Syndrome, sponsored by Aldeyra Therapeutics, Inc.. Completed at 3 sites in United States. Open to participants aged 6 Years and older. Per ClinicalTrials.gov, last updated 2022-12-13.

Sponsored by Aldeyra Therapeutics, Inc. · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 12
Allocation: Randomized
Ages: 6 Years and older
Sex: All

Study 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.

Conditions studied

Sjögren-Larsson Syndrome

Browse trials for

Ichthyosis 33

Keywords

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

In context

Ichthyosis

33 studies on the registry are indexed under Ichthyosis; 11 are open to participants now.

This study's enrollment of 12 is below the median of 26 across 23 interventional studies indexed under Ichthyosis.

Browse Ichthyosis studies →

Lead sponsor

Aldeyra Therapeutics, Inc. is the lead sponsor of 35 studies on the registry; 1 is open to participants now.

Of its 29 completed or terminated interventional studies of FDA-regulated products, 25 (86%) have results posted.

Browse Aldeyra Therapeutics, Inc. studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 6 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Genetically-confirmed diagnosis of SLS
Active ichthyosis on the lower extremities that is determined to be at least moderate severity

Exclusion criteria

Exclusion Criteria:

Evidence of an active infection
Currently receiving therapy, including intermittent or low-dose 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 systemic or topically administered drug within 30 days before screening

Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 12 participants (actual)

Study arms

Experimental
Active topical NS2 1% dermatologic cream
NS2 1% topical cream for dermal application
Drug: Active topical NS2 1% dermatologic cream
Placebo comparator
Topical vehicle dermatologic
Vehicle placebo for dermal application
Drug: Vehicle placebo 0.0% NS2 dermatologic cream

Interventions

DrugActive topical NS2 1% dermatologic cream
DrugVehicle placebo 0.0% NS2 dermatologic cream

What researchers measure

Primary outcomes

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.

Results

Posted Dec 13, 2022

Participant flow

Participant flow — Overall Study
Milestone	Topical NS2 1% Dermatologic Cream	Topical Vehicle Dermatologic
Started	6	6
Completed	6	6
Not completed	0	0

Outcome measures

PrimaryNumber of Participants Experiencing a Serious Adverse Event (SAE).

Time frame:: The safety assessment period is approximately 9 weeks.
Reported as:: Count of participants · Participants

Number of Participants Experiencing a Serious Adverse Event (SAE).
Participants	Topical NS2 1% Dermatologic Cream	Topical Vehicle Dermatologic
Number of Participants Experiencing a Serious Adverse Event (SAE).	0	0

PrimaryNumber of Participants Experiencing an Adverse Event Leading to Discontinuation.

Time frame:: The safety assessment period is approximately 9 weeks.
Reported as:: Count of participants · Participants

Number of Participants Experiencing an Adverse Event Leading to Discontinuation.
Participants	Topical NS2 1% Dermatologic Cream	Topical Vehicle Dermatologic
Number of Participants Experiencing an Adverse Event Leading to Discontinuation.	0	0

Adverse events

Collected over Adverse event data was captured for approximately 9 weeks for each subject during clinical trial participation.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Topical NS2 1% Dermatologic Cream	0/6 (0%)	0/6 (0%)	5/6 (83.3%)
Topical Vehicle Dermatologic	0/6 (0%)	0/6 (0%)	3/6 (50%)

Most frequent other events

Showing 10 of 18

Most frequent other events
Event	Topical NS2 1% Dermatologic Cream	Topical Vehicle Dermatologic
PruritusSkin and subcutaneous tissue disorders	2/6	0/6
BlisterSkin and subcutaneous tissue disorders	0/6	1/6
RashSkin and subcutaneous tissue disorders	0/6	1/6
Skin ulcerSkin and subcutaneous tissue disorders	0/6	1/6
NasopharyngitisInfections and infestations	0/6	1/6
Tooth abscessInfections and infestations	1/6	0/6
Upper respiratory tract infectionInfections and infestations	1/6	0/6
ArthralgiaMusculoskeletal and connective tissue disorders	1/6	1/6
Joint swellingMusculoskeletal and connective tissue disorders	0/6	1/6
MyalgiaMusculoskeletal and connective tissue disorders	1/6	0/6

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Topical NS2 1% Dermatologic Cream	Topical Vehicle Dermatologic	Total
Mean	14.2 ± 5.08	17.3 ± 5.01	15.8 ± 5.08

Sex: Female, Male
Sex: Female, Male(Participants)	Topical NS2 1% Dermatologic Cream	Topical Vehicle Dermatologic	Total
Female	3	3	6
Male	3	3	6

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Topical NS2 1% Dermatologic Cream	Topical Vehicle Dermatologic	Total
Hispanic or Latino	1	0	1
Not Hispanic or Latino	5	6	11
Unknown or Not Reported	0	0	0

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	Topical NS2 1% Dermatologic Cream	Topical Vehicle Dermatologic	Total
Asian	0	0	0
Black or African American	2	1	3
Native Hawaiian or Pacific Islander	0	0	0
White	3	5	8
Other	1	0	1

Region of Enrollment
Region of Enrollment(Participants)	Topical NS2 1% Dermatologic Cream	Topical Vehicle Dermatologic	Total
United States	6	6	12

Height
Height(centimeters)	Topical NS2 1% Dermatologic Cream	Topical Vehicle Dermatologic	Total
Mean	150.0 ± 19.71	157.2 ± 9.14	153.6 ± 15.13

Weight
Weight(kilograms)	Topical NS2 1% Dermatologic Cream	Topical Vehicle Dermatologic	Total
Mean	41.4 ± 13.07	59.8 ± 14.36	50.6 ± 16.24

Body Surface Area
Body Surface Area(Mosteller Method (m2))	Topical NS2 1% Dermatologic Cream	Topical Vehicle Dermatologic	Total
Mean	1.54 ± 0.527	1.95 ± 0.890	1.77 ± 0.743

Study locations

3 sites

University of Nebraska Medical Center
Omaha, Nebraska 68198, United States
Penn State Hershey Medical Center - Department of Dermatology
Hershey, Pennsylvania 17033, United States
Pediatric and General Dermatology
Fairfax, Virginia 22031, United States

Timeline

Tracking since Sep 25, 2026

Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Mar 2015, a primary completion of May 2016 and a completion of Jun 2016. It does not say whether these dates are actual or estimated.

Results were first posted in Dec 2022, 6 years 7 months after primary completion. A results delay was requested in Mar 2019.

How these figures are worked out, and which studies are left out of them.

Registered: Mar 17, 2015
First posted: Mar 30, 2015
Start: Mar 2015
Primary completionActual: May 2016
CompletionActual: Jun 2016
Results delay requested: Mar 13, 2019
Results first posted: Dec 13, 2022
Last update: Dec 13, 2022

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Dec 13, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02402309
Lead sponsor: Aldeyra Therapeutics, Inc.
Responsible party: Sponsor
First posted: Mar 30, 2015
Start date: Mar 2015
Primary completion: May 2016
Completion: Jun 2016
Results posted: Dec 13, 2022
Last update: Dec 13, 2022

Study contacts

William B. Rizzo, MD

principal investigator · University of Nebraska

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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