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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-18

Study Completion Date

2020-01-18

Brief Summary

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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 in Subjects with Sjögren-Larsson Syndrome (SLS).

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Detailed Description

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Conditions

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Sjogren-Larsson Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ADX-102 1% Topical Dermal Cream (reproxalap)

Group Type EXPERIMENTAL

ADX-102 1% Topical Dermal Cream (reproxalap)

Intervention Type DRUG

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

Vehicle of ADX-102 Topical Dermal Cream

Group Type PLACEBO_COMPARATOR

Vehicle of ADX-102 Topical Dermal Cream

Intervention Type DRUG

Vehicle of ADX-102 Topical Dermal Cream administered approximately every 24 hours for 6 months.

Interventions

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ADX-102 1% Topical Dermal Cream (reproxalap)

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

Intervention Type DRUG

Vehicle of ADX-102 Topical Dermal Cream

Vehicle of ADX-102 Topical Dermal Cream administered approximately every 24 hours for 6 months.

Intervention Type DRUG

Eligibility Criteria

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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 Visual Index Ichthyosis Severity (VIIS) 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.

Minimum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No