RESET Trial - Part 1 (Followed by Reset Trial - Part 2) - A Phase 3 Trial in Subjects With Sjögren-Larsson Syndrome (SLS)
- Study HIC#:2000022606
- Last Updated:08/23/2018
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).
- Age3 years and older
- Start Date08/19/2018
- End Date12/30/2020
Trial Purpose and Description
Primary Objective: To evaluate the efficacy of ADX-102 1% topical dermal cream for treatment of ichthyosis associated with SLS.
Secondary Objectives: To evaluate the safety and efficacy of ADX-102 1% topical dermal cream in subjects with SLS.
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.
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.