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

NCT03445650 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2023-02-09

Study results available
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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

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.

Sponsors & Collaborators

  • Aldeyra Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-18
Primary Completion
2020-01-18
Completion
2020-01-18
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03445650 on ClinicalTrials.gov