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

NCT05979506 · tracked via the Priya Life Science France tracker

Sponsor

University Hospital, Toulouse

Phase

Not applicable

Started

2024-02-02

Last updated

2026-04-13

Condition(s) studied

Ichthyosis Inherited

Investigational drug(s) / intervention(s)

Cutaneous wraps

Cutaneous wraps: The topical treatment that will be used in this study are: * For the body, an emollient cream with a high lipid content: Cold cream * For the scalp and feet, an emollient preparation with keratolytic action: 10% or 30% urea, depending on the scalp and feet damage Each of the 3 treatments (body, scalp and feet) will be carried out as follows: * Application of different topicals all over the body and face, after taking a lukewarm therapeutic bath of 20 minutes * Occlusion by "wrapping" the patient in a plastic film, then covering with a blanket * After 1 hour, the unabsorbed excess cream is removed with a towel

Study summary

Ichthyosis is a group of rare and chronic genetic diseases beginning at birth, in which the patient's skin is covered with scales of variable appearance and severity. This disease is disabling. The treatment is symptomatic and is based on the daily application of moisturizing creams with a high lipid content. Nevertheless, the effectiveness of these treatments is limited and are considered very painful by the patients. Wraps are local treatments carried out by specialized nurses and which consist in, following a therapeutic bath, applying a large quantity of cream to the whole body, followed by an occlusion. This type of care is simple to perform, but requires nursing expertise, to date, it is not carried out in standard practice in France, which is why the investigateur wish to evaluate the effect of wraps on different parameters reflecting the skin condition in the short and medium term.

Eligibility

Sex

ALL

Min age

15 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Patient with hereditary ichthyosis regardless of the clinical form * Patient with a scaling or erythema score \> 6/16 * Patient with a skin discomfort score \> 3/10 * Patient having given written, free and informed consent * Patient affiliated to a social security scheme Exclusion Criteria: * Patient with a skin disease other than ichthyosis * Patient having modified his treatments for ichthyosis in the month preceding inclusion * Patient with known intolerance or allergy to one of the topicals used in the study * Patient unable to complete the study questionnaires * Patient under a protection regime

Primary outcome measure(s)

Skin discomfort Analogue Visual Scale (AVS) — day 11
Percentage of patients showing a reduction of at least 3 points of their skin discomfort in the entire body, measured with the AVS scale (0-10) of cutaneous discomfort between baseline and 11 days after treatment

Trial sites (1)

Facility	City	Region	Status
Toulouse University hospital	Toulouse	France	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05979506 on ClinicalTrials.gov ↗ ← All trials in France