Clinical trial NCT05979506: Evaluate the Evolution of Body and Scalp Skin Discomfort in Patients With Hereditary Ichthyosis After Wraps (EnvelopIchtyose)
Official title: Evaluate the Evolution of Cutaneous Discomfort of the Body and Scalp After 3 Wraps, in Patients With Moderate to Very Severe Hereditary Ichthyosis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Ichthyosis Inherited
Keywords: Ichthyosis
inherited
wraps
skin scales
cutaneous abnormalities
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2023-08-07
Enrollment: 34
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Interventional, prospective, multicenter (Toulouse - Bordeaux - Paris Necker), comparative (baseline vs. short and medium term)
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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. There are 2 distinct typical profiles: patients with thick scales without erythroderma and patients with finer scales on an erythrodermic background. This disease is disabling, in particular due to sensations of pruritus, skin pain and the possible presence of associated extra-cutaneous abnormalities. The treatment is symptomatic and is based on the daily application of moisturizing creams with a high lipid content for better effectiveness, keratolytic creams, and for severe forms, oral retinoids may be necessary. The creams improve the condition of the skin and reduce the sensations of skin discomfort, pain and pruritus, 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. The type of cream is adapted to the area of application: thus, an emollient cream is used for the body; a cream enriched with keratolytic active ingredients is used for the feet in the event of hyperkeratosis, and an emollient cream possibly enriched with keratolytic active ingredients is used for the scalp, followed by an exposure time under a steam helmet to remove scales. This type of care is simple to perform, but requires nursing expertise, to date, it is not carried out in standard practice in France, except in the centers of Toulouse, Bordeaux and Necker and at the thermal cure of Avène-les-Bains. However, the interest of such a treatment has never been evaluated independently, which is why in this study the investigators want to evaluate the effect of carrying out a daily treatment over 3 consecutive days, on different parameters reflecting the skin condition in the short and medium term

Eligibility criteria: 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 outcomes:
measure: Skin discomfort Analogue Visual Scale (AVS)
timeFrame: day 11
Secondary outcomes:
measure: Reduction of skin discomfort - day 4
timeFrame: day 4
measure: Reduction of skin discomfort - day 30
timeFrame: day 30
measure: Variation of erythema and scales severity - VIIS
timeFrame: day 4
measure: Variation of erythema and scales severity
timeFrame: day 4
measure: Cutaneous pain - day 4
timeFrame: day 4
measure: pruritus - day 4
timeFrame: day 4
measure: sweating - day 4
timeFrame: day 4
measure: Cutaneous pain - day 11
timeFrame: day 11
measure: pruritus - day 11
timeFrame: day 11
measure: sweating - day 11
timeFrame: day 11
measure: Cutaneous pain - day 30
timeFrame: day 30
measure: pruritus - day 30
timeFrame: day 30
measure: sweating - day 30
timeFrame: day 30
measure: Feet and scalp discomfort - day 4
timeFrame: day 4
measure: Feet and scalp discomfort - day 11
timeFrame: day 11
measure: Feet and scalp discomfort - day 30
timeFrame: day 30
measure: 32-item Ichthyosis Quality of Life questionnaire (IQoL-32)
timeFrame: 30 days after treatment
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Toulouse University hospital
Study officials:
affiliation: University Hospital, Toulouse
name: Anne-Marie TRANIER
role: PRINCIPAL_INVESTIGATOR
References: