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

January 11, 2023 updated by: Aldeyra Therapeutics, Inc.

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)

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • Yale University
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • University of Nebraska Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: ADX-102 1% Topical Dermal Cream (reproxalap)
Drug: ADX-102 1% Topical Dermal Cream (reproxalap)
ADX-102 1% Topical Dermal Cream administered approximately every 24 hours for 6 months.
PLACEBO_COMPARATOR: Vehicle of ADX-102 Topical Dermal Cream
Drug: Vehicle of ADX-102 Topical Dermal Cream
Vehicle of ADX-102 Topical Dermal Cream administered approximately every 24 hours for 6 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Efficacy assessment period (Week 1 through Week 24), where Baseline is Day 1.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aldeyra Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 18, 2018

Primary Completion (ACTUAL)

January 18, 2020

Study Completion (ACTUAL)

January 18, 2020

Study Registration Dates

First Submitted

February 14, 2018

First Submitted That Met QC Criteria

February 23, 2018

First Posted (ACTUAL)

February 26, 2018

Study Record Updates

Last Update Posted (ESTIMATE)

February 9, 2023

Last Update Submitted That Met QC Criteria

January 11, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ADX-102-SLS-006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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