RecruitingNAINTERVENTIONAL

Evaluate the Evolution of Body and Scalp Skin Discomfort in Patients With Hereditary Ichthyosis After Wraps (EnvelopIchtyose)

This study is for people in the UK with a skin condition called inherited ichthyosis, which causes scaly skin from birth. Current treatments, mainly daily moisturising creams, don't always work very well and can be uncomfortable. This research is investigating a treatment called "wraps." This involves a special bath, applying a large amount of cream to the whole body, and then covering it. While simple to do, it needs a trained nurse. This method isn't widely used in France, where the study is taking place, so researchers want to officially check how well these wraps improve skin discomfort and reduce scales. They'll be looking at both short-term and longer-term effects to see if this could be a better way to manage ichthyosis.

At a glance

Status

Recruiting

Phase

Sponsor

University Hospital, Toulouse

Enrolment target

Start

02 Feb 2024

Estimated completion

10 Oct 2026

Ichthyosis Inherited

What is this study about?

Ichthyosis is a group of rare, lifelong genetic skin conditions that people are born with. It causes the skin to become scaly, and the severity and appearance of these scales can vary greatly from person to person. Living with ichthyosis can be very challenging, causing discomfort, itching, and pain. It can also sometimes lead to other health issues not related to the skin. Currently, treatment focuses on easing symptoms, often through daily use of very rich moisturisers. However, these aren't always effective and can sometimes be painful or messy for patients to apply.

This study is looking into a different type of treatment called "wraps." This treatment involves having a therapeutic bath, then a trained nurse applies a generous amount of cream all over the body, which is then covered. Different creams might be used for different areas; for example, a special cream might be used for very thick skin on the feet, and a steamed cap might be used for the scalp. This kind of care seems fairly simple, but it does need a nurse with specific skills to do it properly.

The main goal of this research is to see if these skin wraps can make a real difference for people with ichthyosis. Even though they are used in a few specialist centres, researchers haven't properly studied how well they work on their own. The study will assess if the wraps help reduce skin discomfort and scales in the short term (over three days) and the medium term. By carefully checking different measures of skin health, the researchers hope to understand if wraps could offer a more effective and comfortable way to manage this condition.

Key takeaways

Targets inherited ichthyosis, a scaly skin condition.
Investigates "wraps" as a new treatment approach.
Aims to reduce skin discomfort, itching, and scaling.
Involves daily special baths and cream applications by nurses.
Seeks to find a more effective and comfortable treatment.
Study is taking place in France.

Who may be eligible?

To be able to take part in this study, you would generally need to have inherited ichthyosis, no matter what specific type you have. Your skin also needs to show a certain level of scaling or redness (a score above 6 out of 16) and you should be experiencing some skin discomfort (a score above 3 out of 10). You must also be able to understand and sign a consent form, agreeing to take part, and be covered by a social security scheme, as this study is taking place in France.

There are also some reasons why you might not be able to join. For example, if you have another skin condition apart from ichthyosis, or if you've recently changed your ichthyosis treatments in the last month, you likely wouldn't be eligible. You also can't join if you know you're allergic to any of the creams used in the study, or if you wouldn't be able to fill out the study questionnaires. The study is open to both male and female patients aged 15 years and older.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I have inherited ichthyosis.
My skin has noticeable scaling or redness.
I experience some skin discomfort.
I am age 15 or older.
I haven't changed my ichthyosis treatment in the last month.
I don't have other serious skin conditions.

Answer every question to see your result.

What does participation involve?

This study involves a daily treatment for three consecutive days. Each day, you would have a therapeutic bath, followed by specialized nurses applying a large quantity of cream to your entire body and then covering it. For specific areas like the feet or scalp, different creams or techniques (like a steam helmet for the scalp) might be used. Throughout the study, various aspects of your skin condition, such as scaling, redness, and discomfort, will be assessed. The total duration of your active participation, including follow-up for medium-term effects, will be explained by the study team.

Potential risks and benefits

Taking part in this study might offer a potential benefit of improved skin comfort and reduced scaling from the wrap treatment, which could be more effective than your current routine. However, like any new treatment, there could be risks, such as skin irritation or an allergic reaction to the creams used, although efforts will be made to minimise these. You have the full right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Toulouse University hospital
Verified postcode
Toulouse, France· Recruiting

Common questions

What is inherited ichthyosis?

It's a group of rare, lifelong skin conditions present from birth that cause the skin to be scaly and dry.

What are 'wraps' in this study?

Wraps involve a special bath, followed by a lot of cream applied to the body and then covered, done by a trained nurse.

Will I have to pay to take part?

No, if you meet the eligibility criteria and are affiliated with a social security scheme, treatment and assessments related to the study are usually covered.

How long will my participation last?

The main treatment period is over three consecutive days, with assessments looking at short and medium-term effects.

Can I stop participating if I want to?

Yes, you are free to withdraw from the study at any time without needing to give a reason, and it won't affect your medical care.

How to find out more

Anne-Marie TRANIER

tranier.am@chu-toulouse.fr 05 67 77 14 57 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.