The first patient has been enrolled onto a Phase 3 clinical trial investigating topical dermal reproxalap as a possible treatment for Sjögren-Larsson syndrome associated ichthyosis. The original article can be read here, at PR Newswire.
About Sjögren-Larsson Syndrome (SLS)
According to the NIH, Sjögren-Larsson syndrome is a rare genetic condition that typically develops in early childhood. Many children with SLS are born prematurely, and over time are likely to develop ichthyosis (dry, scaly skin), and neurological and eye issues. Another common symptom of SLS is itchiness.
The Phase 3 Study
Aldeyra Therapeutics has announced that the first patient has now been enrolled onto a pivotal Phase 3 study of topical dermal reproxalap for the treatment of ichthyosis linked to SLS.
This study is planned to be a randomised and double-blind clinical trial that takes place over several centres. It will be divided into two parts. Part one of the trial will look at the effects of treating ichthyosis on increasing areas of the body over a period of six months. Data taken from this phase will be used to check the statistical analysis of the second part. The second part plans to look at the effects of six months of treatment on all body areas that are affected by ichthyosis. Researchers will be looking to see how much patients’ ichthyosis improves.
According to information on the government Clinical Trials website, the study is currently expected to enrol around 39 participants, begin in 2018, and be completed in 2020. Participants will be both male and female, and over three years old, amongst other inclusion and exclusion criteria.
A spokesperson for the company says that this trial is part of the company’s “ongoing commitment” to develop a therapy for patients affected by SLS.
The decision to go ahead with the Phase 3 clinical trial was based in part on the encouraging results found in a previous Phase 2 clinical trial.
The Phase 2 Clinical Trial
The Phase 2 study was a randomised and double-blind trial. In it, six patients with SLS were given treatment. All of these six participants showed improvement in ichthyosis over the course of treatment.
