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CompletedNCT03445650Updated Feb 9, 2023Results posted

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

A Phase 3 interventional study of ADX-102 1% Topical Dermal Cream (reproxalap) and Vehicle of ADX-102 Topical Dermal Cream in Sjogren-Larsson Syndrome, sponsored by Aldeyra Therapeutics, Inc.. Completed at 2 sites in United States. Open to participants aged 3 Years and older. Per ClinicalTrials.gov, last updated 2023-02-09.

Sponsored by Aldeyra Therapeutics, Inc. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
11
Allocation
Randomized
Ages
3 Years and older
Sex
All
01

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).

02

Conditions studied

  • Sjogren-Larsson Syndrome

Keywords

  • ADX-102, Sjögren-Larsson Syndrome
03

Who can participate

Ages eligible
3 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
11 participants (actual)

Study arms

  • Experimental
    ADX-102 1% Topical Dermal Cream (reproxalap)

    Drug: ADX-102 1% Topical Dermal Cream (reproxalap)

  • Placebo comparator
    Vehicle of ADX-102 Topical Dermal Cream

    Drug: Vehicle of ADX-102 Topical Dermal Cream

Interventions

  • DrugADX-102 1% Topical Dermal Cream (reproxalap)

    ADX-102 1% Topical Dermal Cream administered approximately every 24 hours for 6 months.

  • DrugVehicle of ADX-102 Topical Dermal Cream

    Vehicle of ADX-102 Topical Dermal Cream administered approximately every 24 hours for 6 months.

05

What researchers measure

Primary outcomes

  1. 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

    Time frame: Efficacy assessment period (Week 1 through Week 24), where Baseline is Day 1.

06

Results

Posted Feb 9, 2023

Participant flow

Participant flow — Overall Study
MilestoneADX-102 1% Topical Dermal CreamVehicle Topical Dermal Cream
Started74
Completed63
Not completed11

Outcome measures

PrimaryVisual 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

Time frame:
Efficacy assessment period (Week 1 through Week 24), where Baseline is Day 1.
Reported as:
Least squares mean · units on a scale
Visual Index Ichthyosis Severity (VIIS) Scaling Score as Assessed by the Investigator in ADX-102 Treated Patients
units on a scaleADX-102 1% Topical Dermal Cream
Visual Index Ichthyosis Severity (VIIS) Scaling Score as Assessed by the Investigator in ADX-102 Treated Patients-0.7 ± 0.22

Adverse events

Collected over The period of time when adverse events were collected was approximately 28 weeks.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
ADX-102 1% Topical Dermal Cream0/7 (0%)0/7 (0%)6/7 (85.7%)
Vehicle Topical Dermal Cream0/4 (0%)0/4 (0%)2/4 (50%)
Most frequent other events
Showing 10 of 25
Most frequent other events
EventADX-102 1% Topical Dermal CreamVehicle Topical Dermal Cream
PruritusSkin and subcutaneous tissue disorders3/70/4
EosinophiliaBlood and lymphatic system disorders2/70/4
RashSkin and subcutaneous tissue disorders1/71/4
Dermatatitis diaperSkin and subcutaneous tissue disorders0/71/4
HyperhidrosisSkin and subcutaneous tissue disorders0/71/4
HordeolumInfections and infestations1/71/4
InfluenzaInfections and infestations0/71/4
Pharyngitis streptococcalInfections and infestations0/71/4
Pneumonia respiratory syncytial viralInfections and infestations0/71/4
SinusitisInfections and infestations0/71/4

Baseline characteristics

Age, Continuous
Age, Continuous(years)ADX-102 1% Topical Dermal CreamVehicle Topical Dermal CreamTotal
Mean18.1 ± 7.789.5 ± 6.3515.0 ± 8.21
Sex: Female, Male
Sex: Female, Male(Participants)ADX-102 1% Topical Dermal CreamVehicle Topical Dermal CreamTotal
Female336
Male415
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)ADX-102 1% Topical Dermal CreamVehicle Topical Dermal CreamTotal
Hispanic or Latino112
Not Hispanic or Latino639
Unknown or Not Reported000
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)ADX-102 1% Topical Dermal CreamVehicle Topical Dermal CreamTotal
American Indian or Alaska Native000
Asian000
Black or African American213
Native Hawaiian or other Pacific Islander000
White538
Other000
Region of Enrollment
Region of Enrollment(Participants)ADX-102 1% Topical Dermal CreamVehicle Topical Dermal CreamTotal
United States7411
Height
Height(centimeters)ADX-102 1% Topical Dermal CreamVehicle Topical Dermal CreamTotal
Mean150.38 ± 24.583125.68 ± 29.287141.39 ± 27.850
Weight
Weight(kilograms (kg))ADX-102 1% Topical Dermal CreamVehicle Topical Dermal CreamTotal
Mean48.81 ± 18.70829.18 ± 18.86441.67 ± 20.367
Body Mass Index
Body Mass Index(kg/m^2)ADX-102 1% Topical Dermal CreamVehicle Topical Dermal CreamTotal
Mean20.5 ± 3.3616.8 ± 2.8919.1 ± 3.57

1 further baseline measures are reported on the registry.

07

Study locations

2 sites
  • Yale University
    New Haven, Connecticut 06519, United States
  • University of Nebraska Medical Center
    Omaha, Nebraska 68198, United States
08

References and documents

Study documents

  • Study protocol · Oct 17, 2017
  • Statistical analysis plan · Mar 7, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Registry details

Key details

Study ID
NCT03445650
Lead sponsor
Aldeyra Therapeutics, Inc.
Responsible party
Sponsor
First posted
Feb 26, 2018
Start date
Jul 18, 2018
Primary completion
Jan 18, 2020
Completion
Jan 18, 2020
Results posted
Feb 9, 2023
Last update
Feb 9, 2023

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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