NCT03445650

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Aldeyra Therapeutics, Inc. · Industry
• Sex: All
• Age: 3 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Sjogren-Larsson Syndrome

Interventions

Type	Name	Description
DRUG	ADX-102 1% Topical Dermal Cream (reproxalap)	ADX-102 1% Topical Dermal Cream administered approximately every 24 hours for 6 months.
DRUG	Vehicle of ADX-102 Topical Dermal Cream	Vehicle of ADX-102 Topical Dermal Cream administered approximately every 24 hours for 6 months.

Timeline

• Start date: 2018-07-18
• Primary completion: 2020-01-18
• Completion: 2020-01-18
• First posted: 2018-02-26
• Last updated: 2023-02-09
• Results posted: 2023-02-09

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study