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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active topical NS2 1% dermatologic cream | Experimental | NS2 1% topical cream for dermal application |
|
| Topical vehicle dermatologic | Placebo Comparator | Vehicle placebo for dermal application |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active topical NS2 1% dermatologic cream | Drug |
| ||
| Vehicle placebo 0.0% NS2 dermatologic cream |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William B. Rizzo, MD | University of Nebraska | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | United States | ||
| Penn State Hershey Medical Center - Department of Dermatology |
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| ID | Title | Description |
|---|---|---|
| FG000 | Topical NS2 1% Dermatologic Cream | NS2 1% topical cream for dermal application Active topical NS2 1% dermatologic cream |
| FG001 | Topical Vehicle Dermatologic | Vehicle placebo for dermal application Vehicle placebo 0.0% NS2 dermatologic cream |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Topical NS2 1% Dermatologic Cream | NS2 1% topical cream for dermal application Active topical NS2 1% dermatologic cream |
| BG001 | Topical Vehicle Dermatologic | Vehicle placebo for dermal application Vehicle placebo 0.0% NS2 dermatologic cream |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Experiencing a Serious Adverse Event (SAE). | Posted | Count of Participants | Participants | The safety assessment period is approximately 9 weeks. |
|
|
Adverse event data was captured for approximately 9 weeks for each subject during clinical trial participation.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Topical NS2 1% Dermatologic Cream | NS2 1% topical cream for dermal application Active topical NS2 1% dermatologic cream |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr. Director, Clinical Operations | Aldeyra Therapeutics, Inc. | 781-257-3063 | bcavanagh@aldeyra.com |
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| ID | Term |
|---|---|
| D016111 | Sjogren-Larsson Syndrome |
| D007057 | Ichthyosis |
| ID | Term |
|---|---|
| D012868 | Skin Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008064 | Lipidoses |
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| Drug |
|
| Hershey |
| Pennsylvania |
| 17033 |
| United States |
| Pediatric and General Dermatology | Fairfax | Virginia | 22031 | United States |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Height | Mean | Standard Deviation | centimeters |
|
| Weight | Mean | Standard Deviation | kilograms |
|
| Body Surface Area | Mean | Standard Deviation | Mosteller Method (m2) |
|
| Participants |
|
|
| Primary | Number of Participants Experiencing an Adverse Event Leading to Discontinuation. | Posted | Count of Participants | Participants | The safety assessment period is approximately 9 weeks. |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 5 |
| 6 |
| EG001 | Topical Vehicle Dermatologic | Vehicle placebo for dermal application Vehicle placebo 0.0% NS2 dermatologic cream | 0 | 6 | 0 | 6 | 3 | 6 |
| Blister | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Tooth abscess | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Lethargy | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Urine abnormality | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
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| D008052 | Lipid Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D012873 | Skin Diseases, Genetic |
| D007232 | Infant, Newborn, Diseases |
| D007642 | Keratosis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |