Sjogren-Larsson SyndromePhase 3NCT03445650
RESET Trial - Part 1 - A Phase 3 Trial in Subjects With Sjögren-Larsson Syndrome (SLS)
A Phase 3 study testing ADX-102 1% Topical Dermal Cream (reproxalap) in people with Sjogren-Larsson Syndrome, run by Aldeyra Therapeutics, Inc. at 2 sites in United States.
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). Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Sjogren-Larsson Syndrome
- What is being tested?
- ADX-102 1% Topical Dermal Cream (reproxalap)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 Jul 2018to 18 Jan 2020
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Yale University
New Haven, Connecticut, 06519
University of Nebraska Medical Center
Omaha, Nebraska, 68198
About this study
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)
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
- Being tested
- ADX-102 1% Topical Dermal Cream (reproxalap), Vehicle of ADX-102 Topical Dermal Cream
- Keywords
- ADX-102, Sjögren-Larsson Syndrome
- Medical subject headings
- Sjogren-Larsson Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADX-102 1% Topical Dermal Cream (reproxalap)Drug
ADX-102 1% Topical Dermal Cream administered approximately every 24 hours for 6 months.
Vehicle of ADX-102 Topical Dermal CreamDrug
Vehicle of ADX-102 Topical Dermal Cream administered approximately every 24 hours for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| ADX-102 1% Topical Dermal Cream (reproxalap) | Experimental | Not described Receives: Drug: ADX-102 1% Topical Dermal Cream (reproxalap) |
| Vehicle of ADX-102 Topical Dermal Cream | Placebo comparator | Not described Receives: Drug: Vehicle of ADX-102 Topical Dermal Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Efficacy assessment period (Week 1 through Week 24), where Baseline is Day 1.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2018
- Study start18 Jul 2018
- Primary completion18 Jan 2020
- Study completion18 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Sjogren-Larsson SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aldeyra Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03445650
- Sponsor's protocol ID
- ADX-102-SLS-006
- Status last verified
- Jan 2023
- First submitted
- 14 Feb 2018
- Last updated
- 9 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03445650
- Acronym / sponsor ID
- ADX-102-SLS-006
- Conditions
- Sjogren-Larsson Syndrome
- Keywords
- ADX-102, Sjögren-Larsson Syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Aldeyra Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 18 Jul 2018 (actual)
- Primary completion
- 18 Jan 2020 (actual)
- Study completion
- 18 Jan 2020 (actual)
- First posted
- 26 Feb 2018 (actual)
- Results
- Posted 9 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ADX-102 1% Topical Dermal Cream (reproxalap) | Experimental | Drug: ADX-102 1% Topical Dermal Cream (reproxalap) |
| Vehicle of ADX-102 Topical Dermal Cream | Placebo comparator | Drug: Vehicle of ADX-102 Topical Dermal Cream |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ADX-102 1% Topical Dermal Cream (reproxalap)ADX-102 1% Topical Dermal Cream administered approximately every 24 hours for 6 months. | Drug | ADX-102 1% Topical Dermal Cream (reproxalap) |
| Vehicle of ADX-102 Topical Dermal CreamVehicle of ADX-102 Topical Dermal Cream administered approximately every 24 hours for 6 months. | Drug | Vehicle of ADX-102 Topical Dermal Cream |
Primary outcome
Visual Index Ichthyosis Severity (VIIS) Scaling Score as Assessed by the Investigator in ADX-102 Treated Patients
Time frame: Efficacy assessment period (Week 1 through Week 24), where Baseline is Day 1.
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ADX-102 1% Topical Dermal Cream (reproxalap) in people with Sjogren-Larsson Syndrome, run by Aldeyra Therapeutics, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Index Ichthyosis Severity (VIIS) Scaling Score as Assessed by the Investigator in ADX-102 Treated Patients (time frame: Efficacy assessment period (Week 1 through Week 24), where Baseline is Day 1.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2023.