Trial · NCT03445650
RESET Trial - Part 1 - A Phase 3 Trial in Subjects With Sjögren-Larsson Syndrome (SLS)
NCT03445650, Phase 3, Completed, Aldeyra Therapeutics, Inc.; results first posted 2023-02-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. RESET Trial - Part 1 - A Phase 3 Trial in Subjects With Sjögren-Larsson Syndrome (SLS). Trials, record NCT03445650. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03445650
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- RESET Trial - Part 1 - A Phase 3 Trial in Subjects With Sjögren-Larsson Syndrome (SLS)
- NCT number
- NCT03445650
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 11 participants, actual
- Lead sponsor
- Aldeyra Therapeutics, Inc.
- Conditions
- Sjogren-Larsson Syndrome
- Interventions
- ADX-102 1% Topical Dermal Cream (reproxalap), Vehicle of ADX-102 Topical Dermal Cream
- First posted
- 2018-02-26
- Last updated
- 2023-02-09
- Results first posted
- 2023-02-09
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Visual Index Ichthyosis Severity (VIIS) Scaling Score as Assessed by the Investigator in ADX-102 Treated Patients | 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 |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Visual Index Ichthyosis Severity (VIIS) Scaling Score as Assessed by the Investigator in ADX-102 Treated Patients | Efficacy assessment period (Week 1 through Week 24), where Baseline is Day 1. | modified intent to treat population | units on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group1
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Visual Index Ichthyosis Severity (VIIS) Scaling Score as Assessed by the Investigator in ADX-102 Treated Patients | ADX-102 1% Topical Dermal Cream | -0.7 | Standard Error 0.22 | units on a scale |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | ADX-102 1% Topical Dermal Cream | 7 | |
| Overall Study | STARTED | Vehicle Topical Dermal Cream | 4 | |
| Overall Study | COMPLETED | ADX-102 1% Topical Dermal Cream | 6 | |
| Overall Study | COMPLETED | Vehicle Topical Dermal Cream | 3 | |
| Overall Study | NOT COMPLETED | ADX-102 1% Topical Dermal Cream | 1 | |
| Overall Study | NOT COMPLETED | Vehicle Topical Dermal Cream | 1 |
Source ClinicalTrials.gov
Adverse events50
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Pruritus | Skin and subcutaneous tissue disorders | ADX-102 1% Topical Dermal Cream | 3 | 7 | |
| other | Pruritus | Skin and subcutaneous tissue disorders | Vehicle Topical Dermal Cream | 0 | 4 | |
| other | Rash | Skin and subcutaneous tissue disorders | ADX-102 1% Topical Dermal Cream | 1 | 7 | |
| other | Rash | Skin and subcutaneous tissue disorders | Vehicle Topical Dermal Cream | 1 | 4 | |
| other | Dermatatitis diaper | Skin and subcutaneous tissue disorders | ADX-102 1% Topical Dermal Cream | 0 | 7 | |
| other | Dermatatitis diaper | Skin and subcutaneous tissue disorders | Vehicle Topical Dermal Cream | 1 | 4 | |
| other | Dry Skin | Skin and subcutaneous tissue disorders | ADX-102 1% Topical Dermal Cream | 1 | 7 | |
| other | Dry Skin | Skin and subcutaneous tissue disorders | Vehicle Topical Dermal Cream | 0 | 4 | |
| other | Hyperhidrosis | Skin and subcutaneous tissue disorders | ADX-102 1% Topical Dermal Cream | 0 | 7 | |
| other | Hyperhidrosis | Skin and subcutaneous tissue disorders | Vehicle Topical Dermal Cream | 1 | 4 |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ADX-102 1% Topical Dermal Cream | 0 | 7 |
| Total, all-cause mortality | Vehicle Topical Dermal Cream | 0 | 4 |
| Total, other adverse events | ADX-102 1% Topical Dermal Cream | 6 | 7 |
| Total, other adverse events | Vehicle Topical Dermal Cream | 2 | 4 |
| Total, serious adverse events | ADX-102 1% Topical Dermal Cream | 0 | 7 |
| Total, serious adverse events | Vehicle Topical Dermal Cream | 0 | 4 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| ADX-102 1% Topical Dermal Cream vs Vehicle Topical Dermal Cream: deaths from any cause | Trial comparisons |
| ADX-102 1% Topical Dermal Cream vs Vehicle Topical Dermal Cream: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03445650
GET https://conductscience.org/api/trials/v1/NCT03445650/events?page=2