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

Aldeyra Therapeutics

Status and phase

Completed

Phase 3

Conditions

Sjogren-Larsson Syndrome

Treatments

Drug: Vehicle of ADX-102 Topical Dermal Cream

Drug: ADX-102 1% Topical Dermal Cream (reproxalap)

Study type

Interventional

Funder types

Industry

Identifiers

NCT03445650

ADX-102-SLS-006

Details and patient eligibility

About

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).

Enrollment

11 patients

Sex

All

Ages

3+ years old

Volunteers

No Healthy Volunteers

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.