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

Phase 3

Completed

• Conditions: Sjogren-Larsson Syndrome
• Interventions: Drug: ADX-102 1% Topical Dermal Cream (reproxalap); Drug: Vehicle of ADX-102 Topical Dermal Cream

• Registration Number: NCT03445650
• Lead Sponsor: Aldeyra Therapeutics, Inc.

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-02-14
• Study First Submitted QC: 2018-02-23
• Study First Posted: 2018-02-26
• Study Start: 2018-07-18
• Primary Completion: 2020-01-18
• Study Completion: 2020-01-18
• Results First Submitted: 2022-12-19
• Status Verified: 2023-01
• Results First Submitted QC: 2023-01-11
• Last Update Submitted: 2023-01-11
• Results First Posted: 2023-02-09
• Last Update Posted: 2023-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ADX-102 1% Topical Dermal Cream (reproxalap)	ADX-102 1% Topical Dermal Cream (reproxalap)	-
Vehicle of ADX-102 Topical Dermal Cream	Vehicle of ADX-102 Topical Dermal Cream	-

Primary Outcome Measures

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

Trial Locations

Locations (2)

Yale University; 🇺🇸 New Haven, Connecticut, United States

University of Nebraska Medical Center; 🇺🇸 Omaha, Nebraska, United States