Status:
COMPLETED
RESET Trial - Part 1 - A Phase 3 Trial in Subjects With Sjögren-Larsson Syndrome (SLS)
Lead Sponsor:
Aldeyra Therapeutics, Inc.
Conditions:
Sjogren-Larsson Syndrome
Eligibility:
All Genders
3+ years
Phase:
PHASE3
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).
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 18 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 18 2020
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT03445650
Start Date
July 18 2018
End Date
January 18 2020
Last Update
February 9 2023
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Yale University
New Haven, Connecticut, United States, 06519
2
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198