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

Sponsor

University Hospital, Toulouse (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05979506

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

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, 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. 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 we wish to evaluate the effect of wraps on different parameters reflecting the skin condition in the short and medium term.

Condition or Disease	Intervention/Treatment	Phase
Ichthyosis Inherited	Procedure: Cutaneous wraps	N/A

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 we want to evaluate the effect of carrying out a daily treatment (including a therapeutic bath, a wrap (body and feet) and scalp care) over 3 consecutive days, on different parameters reflecting the skin condition in the short and medium term

Study Design

Study Type:

Interventional

Anticipated Enrollment :

34 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Interventional, prospective, multicenter (Toulouse - Bordeaux - Paris Necker), comparative (baseline vs. short and medium term)Interventional, prospective, multicenter (Toulouse - Bordeaux - Paris Necker), comparative (baseline vs. short and medium term)

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Apr 1, 2025

Anticipated Study Completion Date :

Apr 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Wraps (body and feet) as well as scalp care The skin care consisting of wraps (body and feet) and scalp care, will be carried out consecutively over 3 days, in the hospital (outpatient or in day/traditional hospitalization).	Procedure: 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

Arm

Intervention/Treatment

Experimental: Wraps (body and feet) as well as scalp care

The skin care consisting of wraps (body and feet) and scalp care, will be carried out consecutively over 3 days, in the hospital (outpatient or in day/traditional hospitalization).

Procedure: 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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Reduction of skin discomfort - day 4 [day 4]
Percentage of patients showing a reduction of at least 3 points of their skin discomfort in the entire body, measured with the Analogue Visual Scale (AVS) (0-10) of cutaneous discomfort between baseline and day 4
Reduction of skin discomfort - day 30 [day 30]
Percentage of patients showing a reduction of at least 3 points of their skin discomfort in the entire body, measured with the Analogue Visual Scale (AVS) (0-10) of cutaneous discomfort between baseline and day 30
Variation of erythema and scales severity - VIIS [day 4]
Variation of erythema and scales severity judged by : - Their intensity, measured with the Visual Index for Ichthyosis Severity (VIIS)
Variation of erythema and scales severity [day 4]
Variation of erythema and scales severity judged by : -Their extent, measured with the scores A and B of the Specific Clinical Ichthyosis Score
Cutaneous pain - day 4 [day 4]
Variation of pain assessed by the Analogue Visual Scale (0-10) of skin pain
pruritus - day 4 [day 4]
Variation of pruritus assessed by the Analogue Visual Scale (0-10)
sweating - day 4 [day 4]
Variation of sweating assessed by the Analogue Visual Scale (0-10)
Cutaneous pain - day 11 [day 11]
Variation of pain assessed by the Analogue Visual scale (0-10) of skin pain
pruritus - day 11 [day 11]
Variation of pruritus assessed by the Analogue Visual scale (0-10)
sweating - day 11 [day 11]
Variation of sweating assessed by the Analogue Visual Scale scale (0-10)
Cutaneous pain - day 30 [day 30]
Variation of pain assessed by the Analogue Visual Scale (0-10) of skin pain
pruritus - day 30 [day 30]
Variation of pruritus assessed by the Analogue Visual Scale scale (0-10)
sweating - day 30 [day 30]
Variation of sweating assessed by the Analogue Visual Scale (0-10)
Feet and scalp discomfort - day 4 [day 4]
Percentage of patients showing a reduction of at least 3 points of their skin discomfort in the feet and scalp, measured with the Analogue Visual Scale (0-10) of cutaneous discomfort
Feet and scalp discomfort - day 11 [day 11]
Percentage of patients showing a reduction of at least 3 points of their skin discomfort in the feet and scalp, measured with the Analogue Visual Scale (0-10) of cutaneous discomfort
Feet and scalp discomfort - day 30 [day 30]
Percentage of patients showing a reduction of at least 3 points of their skin discomfort in the feet and scalp, measured with the Analogue Visual Scale (0-10) of cutaneous discomfort
32-item Ichthyosis Quality of Life questionnaire (IQoL-32) [30 days after treatment]
Variation of patient's quality of life, measured by the ichthyosis specific quality of life questionnaire (IQoL-32)

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years and Older

Sexes Eligible for Study:

All

Accepts 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