RESET Trial - Part 1 (Followed by Reset Trial - Part 2) - A Phase 3 Trial in Subjects With Sjögren-Larsson Syndrome (SLS)

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	3 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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 VIIS scaling severity score.

- Females of child-bearing potential: Negative pregnancy test at Screening and Baseline Visits.

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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03445650
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Aldeyra Therapeutics, Inc.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Sjogren-Larsson Syndrome

Arms & Interventions

Arms

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

Placebo Comparator: Vehicle of ADX-102 Topical Dermal Cream

Interventions

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

ADX-102 1% Topical Dermal Cream administered approximately every 24 hours for 6 months in Part 1 and Part 2.

Drug: - Vehicle of ADX-102 Topical Dermal Cream

Vehicle of ADX-102 Topical Dermal Cream administered approximately every 24 hours for 6 months in Part 1 and Part 2.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Yale University, New Haven, Connecticut

Status

Recruiting

Address

Yale University

New Haven, Connecticut, 06519

Site Contact

Keith A. Choate, MD

[email protected]

781-761-4904

University of Nebraska Medical Center, Omaha, Nebraska

Status

Recruiting

Address

University of Nebraska Medical Center

Omaha, Nebraska, 68198

Site Contact

William B. Rizzo, MD

[email protected]

781-761-4904

Clinical Trial Finder