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



Status:Recruiting
Conditions:Rheumatology
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:3 - Any
Updated:3/9/2019
Start Date:July 19, 2018
End Date:December 2020
Contact:Carolyn Soo, Pharm. D.
Email:csoo@aldeyra.com
Phone:781-761-4904

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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).


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.
We found this trial at
2
sites
Emile St
Omaha, Nebraska 68198
(402) 559-4000
Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
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Omaha, NE
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New Haven, Connecticut 6520
(203) 432-4771
Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
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New Haven, CT
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