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

Sjogren-Larsson Syndrome Clinical Trial

Official 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03445650
• Other study ID #: ADX-102-SLS-006
• Status: Completed
• Phase: Phase 3
• Start date: July 18, 2018
• Est. completion date: January 18, 2020

Study information

• Verified date: January 2023
• Source: Aldeyra Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: January 18, 2020
• Est. primary completion date: January 18, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Sjogren's Syndrome
• Sjogren-Larsson Syndrome
• Syndrome

Intervention

Drug:
• ADX-102 1% Topical Dermal Cream (reproxalap)
ADX-102 1% Topical Dermal Cream administered approximately every 24 hours for 6 months.
• Vehicle of ADX-102 Topical Dermal Cream
Vehicle of ADX-102 Topical Dermal Cream administered approximately every 24 hours for 6 months.

Locations

Country	Name	City	State
United States	Yale University	New Haven	Connecticut
United States	University of Nebraska Medical Center	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
Aldeyra Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Index Ichthyosis Severity (VIIS) Scaling Score as Assessed by the Investigator in ADX-102 Treated Patients	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.