RESET Trial - Part 1 - A Phase 3 Trial in Subjects With Sjögren-Larsson Syndrome (SLS)

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).

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Key information

Conditions

Sjogren-Larsson Syndrome Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Ichthyosis Infant, Newborn, Diseases Keratosis Lipid Metabolism Disorders Lipid Metabolism, Inborn Errors Lipidoses Metabolic Diseases Metabolism, Inborn Errors Nutritional and Metabolic Diseases Skin Abnormalities Skin Diseases Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

3 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Yale University, New Haven, Connecticut, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ADX-102 1% Topical Dermal Cream (reproxalap)

Drug

ADX-102 1% Topical Dermal Cream administered approximately every 24 hours for 6 months.

Vehicle of ADX-102 Topical Dermal Cream

Drug

Vehicle of ADX-102 Topical Dermal Cream administered approximately every 24 hours for 6 months.

Primary outcomes

Visual Index Ichthyosis Severity (VIIS) Scaling Score as Assessed by the Investigator in ADX-102 Treated Patients

Time frame: Efficacy assessment period (Week 1 through Week 24), where Baseline is Day 1.

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

Sponsors and collaborators

Lead sponsor

Aldeyra Therapeutics, Inc.

Industry

Registry information

Official study 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)

Important dates

Study start: 2018
Primary completion: 2020
Study completion: 2020
First posted: Feb 26, 2018
Registry last updated: Feb 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed