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NCT03445650 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study, sponsored by Aldeyra Therapeutics.

Completed
Registry status
Phase 3
Development phase
11
Enrollment target

NCT03445650: Completed Phase 3 study, sponsored by Aldeyra Therapeutics.

NCT03445650 is a Phase 3 study that has completed, run by Aldeyra Therapeutics. The registered enrollment target is 11 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03445650, a Phase 3 study, has completed, sponsored by Aldeyra Therapeutics.

COMPLETED
Registry status
Phase 3
Development phase
11 participants
Enrollment target

Study 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).

Primary Outcome

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

Interventions

  • DRUG ADX-102 1% Topical Dermal Cream (reproxalap)
  • DRUG Vehicle of ADX-102 Topical Dermal Cream

Trial Details

FieldValue
Enrollment Target 11 participants
Start Date 2018-07-18
Est. Completion 2020-01-18
Phase Phase 3
Aldeyra Therapeutics

26 total trials

What the finished NCT03445650 record still lists

NCT03445650 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 2 interventions - of which ADX-102 1% Topical Dermal Cream (reproxalap) is the first listed.

NCT03445650 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03445650 about?

NCT03445650 is a clinical study titled "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 in Subjects with Sjögren-Larsson Syndrome (SLS).

What is the current status of trial NCT03445650?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 11 participants. The study started on 2018-07-18. Estimated completion is 2020-01-18.

What interventions are being tested in trial NCT03445650?

The interventions under investigation include: ADX-102 1% Topical Dermal Cream (reproxalap) (DRUG), Vehicle of ADX-102 Topical Dermal Cream (DRUG).

Who is sponsoring clinical trial NCT03445650?

This trial is sponsored by Aldeyra Therapeutics, which has 26 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03445650's enrollment target sits among peer trials

11 1989th of 2000 higher than 12 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03445650, the US trial registry maintained by the National Library of Medicine. NCT03445650 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.