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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
11
ADX-102 1% Topical Dermal Cream administered approximately every 24 hours for 6 months.
Vehicle of ADX-102 Topical Dermal Cream administered approximately every 24 hours for 6 months.
Yale University
New Haven, Connecticut, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
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.
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