Each individual experiences varying degrees of symptoms even if they share the same diagnosis of Lamellar Ichthyosis. This, combined with the rarity of the condition, can make LI difficult to cope with emotionally, and make you feel alone. We recognize the frustration and pain that LI causes, which is why researchers have developed an investigational cream for the potential treatment of Lamellar Ichthyosis.
The Reflect Study is testing the safety and effectiveness of a topical cream for adults and adolescents living with LI. This investigational cream is applied to the surface of the skin in an effort to reduce LI symptoms such as dry and cracked skin. The Reflect Study aims to help improve symptoms of LI for current and future generations.
LI affects 1 in 100,000 individuals in the United States, characterizing the condition as a rare disease. In children and infants the condition is often referred to as collodion baby or collodion baby syndrome. LI is often identified at birth and is caused by a genetic mutation. Often treated with either a topical cream or an oral supplement, there is currently no cure.
The Reflect Study aims to give those with LI the ability to restore their confidence by easing the condition’s symptoms and to help those affected continue their daily lives without worry or frustration. The stigmas surrounding the disease can often be crippling and clinical studies like the Reflect Study are attempting to not only find a more effective treatment, but to also raise awareness in the community.
The Reflect Study is a clinical research study testing how safe and effective a new investigational topical cream is for those individuals with moderate to severe Lamellar Ichthyosis. This new topical cream was specifically designed to address LI symptoms such as scaling, dryness, itching and roughness of the skin.
Those who qualify for study participation can expect the following:
Study Duration: 12 weeks, with the option to continue for another 12 weeks (up to 24 weeks)
Treatment received: All study participants will randomly receive either the study medication with the active ingredient or placebo for the first 12 weeks (2/3 likelihood of receiving study medication with active ingredient). Those study participants who complete the first 12 weeks of the study and wish to continue for another 12 weeks will receive study medication with the active ingredient (no one will receive placebo).
Treatment Frequency: Twice weekly.
Additional study details can be provided by those clinical trial centers participating in the study, as well as the FAQ section.
Clinical trials are a part of a branch of healthcare that performs research to evaluate the effectiveness and safety of medications or medical devices by monitoring their effects on large groups of people. A clinical research trial involves the use of participants from the general public, called a sample population. This sample population is randomly divided into groups to compare the investigational medication to a control group.
All clinical trials are overseen by a physician who closely monitors all participants for progress and safety. Studies are conducted to better existing medications or to bring new or more effective medications to the general public. Clinical research is used to test medicines, therapies or devices for prevention, treatment, diagnosis or relief of symptoms. When you decide to participate in a clinical trial you are taking an active role in bettering healthcare for current and future generations.
Yes. All eligible individuals are able to participate in this study even if not near a participating clinical trial center. You can find the nearest participating trial center here, who can explain your options and potential for fully subsidized travel arrangements.
Compensation will be provided in those countries who’s regulatory authority allow study participants to receive compensation. Your clinical trial physician will provide you with this, as well as other information, regarding your study participation.
Qualified participants can expect to remain in the study for up to 12 weeks. Following the completion of the study qualified participants may have the option to continue into another 12-week extension.
Those who qualify for the study are divided up into three groups. Two of these groups will receive the investigational medication; the other will receive a placebo. All subjects participating in the 12-week extension will receive investigational medication.
This trial is being conducted at study locations throughout the US, Europe, Israel and Australia. Find a site location below.
Want to learn more about the Reflect Study? Fill out the form below and a member of our team will contact you to answer any questions you have.
Your information will only be used for the purposes of this study.