Back to resultsRESET Trial - Part 1 - A Phase 3 Trial in Subjects With Sjögren-Larsson Syndrome (SLS)
Primary Purpose
Sjogren-Larsson Syndrome
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
ADX-102 1% Topical Dermal Cream (reproxalap)
Vehicle of ADX-102 Topical Dermal Cream
Sponsored by
About this trial
This is an interventional treatment trial for Sjogren-Larsson Syndrome focused on measuring ADX-102, Sjögren-Larsson Syndrome
Eligibility Criteria
Inclusion Criteria:
- Subject is aged 3 years or older
- Subject has a genetically-confirmed diagnosis of SLS.
- Subject has active ichthyosis that is Grade 2 or higher on the VIIS scaling severity score.
- Females of child-bearing potential: Negative pregnancy test at Screening and Baseline Visits.
Exclusion Criteria:
- Subject has evidence of a serious active infection.
- Systemic or topical retinoids or other topical medications, not including emollients, within the past 30 days Baseline Visit 1.
- Subject has received an investigational systemic or topically administered drug within the past 30 days prior to Baseline Visit 1.
- Subject is currently receiving immunosuppressive therapy, including intermittent or low-dose systemic corticosteroids.
- Subject has a known allergic reaction to any ingredients of study drug formulation.
- Subject has any clinically significant laboratory test abnormalities or a history of any other condition that, in the opinion of the Investigator, could compromise the subject's ability to comply with the protocol or that could compromise the subject's safety or the interpretation of the study results.
Sites / Locations
- Yale University
- University of Nebraska Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
ADX-102 1% Topical Dermal Cream (reproxalap)
Vehicle of ADX-102 Topical Dermal Cream
Arm Description
Outcomes
Primary Outcome Measures
Visual Index Ichthyosis Severity (VIIS) Scaling Score as Assessed by the Investigator in ADX-102 Treated Patients
Change from baseline using the Visual Index Ichthyosis Severity (VIIS) Scaling Score (0 = least, 4 = most), where a higher value represents a worse outcome, in ADX-102 treated patients
Secondary Outcome Measures
Full Information
NCT ID
NCT03445650
First Posted
February 14, 2018
Last Updated
January 11, 2023
Sponsor
Aldeyra Therapeutics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03445650
Brief Title
RESET Trial - Part 1 - A Phase 3 Trial in Subjects With Sjögren-Larsson Syndrome (SLS)
Official Title
A Phase 3 Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Trial to Evaluate the Safety and Efficacy of ADX-102 1% Topical Dermal Cream (Reproxalap) in Subjects With Sjögren-Larsson Syndrome (SLS)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
July 18, 2018 (Actual)
Primary Completion Date
January 18, 2020 (Actual)
Study Completion Date
January 18, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aldeyra Therapeutics, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
A Phase 3 Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Trial to Evaluate the Safety and Efficacy of ADX-102 1% Topical Dermal Cream in Subjects with Sjögren-Larsson Syndrome (SLS).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sjogren-Larsson Syndrome
Keywords
ADX-102, Sjögren-Larsson Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ADX-102 1% Topical Dermal Cream (reproxalap)
Arm Type
Experimental
Arm Title
Vehicle of ADX-102 Topical Dermal Cream
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
ADX-102 1% Topical Dermal Cream (reproxalap)
Intervention Description
ADX-102 1% Topical Dermal Cream administered approximately every 24 hours for 6 months.
Intervention Type
Drug
Intervention Name(s)
Vehicle of ADX-102 Topical Dermal Cream
Intervention Description
Vehicle of ADX-102 Topical Dermal Cream administered approximately every 24 hours for 6 months.
Primary Outcome Measure Information:
Title
Visual Index Ichthyosis Severity (VIIS) Scaling Score as Assessed by the Investigator in ADX-102 Treated Patients
Description
Change from baseline using the Visual Index Ichthyosis Severity (VIIS) Scaling Score (0 = least, 4 = most), where a higher value represents a worse outcome, in ADX-102 treated patients
Time Frame
Efficacy assessment period (Week 1 through Week 24), where Baseline is Day 1.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject is aged 3 years or older
Subject has a genetically-confirmed diagnosis of SLS.
Subject has active ichthyosis that is Grade 2 or higher on the Visual Index Ichthyosis Severity (VIIS) score.
Females of child-bearing potential: Negative pregnancy test at Screening and Baseline Visits.
Exclusion Criteria:
Subject has evidence of a serious active infection.
Systemic or topical retinoids or other topical medications, not including emollients, within the past 30 days Baseline Visit 1.
Subject has received an investigational systemic or topically administered drug within the past 30 days prior to Baseline Visit 1.
Subject is currently receiving immunosuppressive therapy, including intermittent or low-dose systemic corticosteroids.
Subject has a known allergic reaction to any ingredients of study drug formulation.
Subject has any clinically significant laboratory test abnormalities or a history of any other condition that, in the opinion of the Investigator, could compromise the subject's ability to comply with the protocol or that could compromise the subject's safety or the interpretation of the study results.
Facility Information:
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
RESET Trial - Part 1 - A Phase 3 Trial in Subjects With Sjögren-Larsson Syndrome (SLS)
We'll reach out to this number within 24 hrs