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Active NS2 1% dermatologic

Phase 2

Sjögren-Larsson Syndrome | Small molecule | Rare Disease |Aldeyra Therapeutics, Inc.|Last Updated: Dec 13, 2022

Target and mechanism

ModalitySmall molecule

Also known as Active topical NS2 1% dermatologic cream

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment12

FDA Designations

No designations recorded

Clinical trial landscape

Active NS2 1% dermatologic · 1 trial · 1 indication

Phase 2 1
NCT02402309A Study of Topical NS2 Cream to Treat Ichthyosis in Sjögren-Larsson Syndrome (SLS)Sjögren-Larsson Syndrome
COMPLETED12 Analytics
PHASE2COMPLETED
A Study of Topical NS2 Cream to Treat Ichthyosis in Sjögren-Larsson Syndrome (SLS)
Sjögren-Larsson Syndrome
NCT0240230912
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Study Endpoints

Primary Endpoints

Number of Participants Experiencing a Serious Adverse Event (SAE).
The safety assessment period is approximately 9 weeks.
Number of Participants Experiencing an Adverse Event Leading to Discontinuation.
The safety assessment period is approximately 9 weeks.
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Active topical NS2 1% dermatologic creamEXPERIMENTALNS2 1% topical cream for dermal application
Topical vehicle dermatologicPLACEBO_COMPARATORVehicle placebo for dermal application

Interventions

NameTypeDescription
Active topical NS2 1% dermatologic creamDRUG -
Vehicle placebo 0.0% NS2 dermatologic creamDRUG -
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Eligibility Criteria

Age Range6 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites3

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 c...

Countries:United States
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