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

Evaluate the Evolution of Cutaneous Discomfort of the Body and Scalp After 3 Wraps, in Patients With Moderate to Very Severe Hereditary Ichthyosis

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Ichthyosis Inherited
• Intervention / Treatment: Procedure: Cutaneous wraps

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 Type: Interventional
• Enrollment (Estimated): 34
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anne-Marie TRANIER; Phone Number: 05 67 77 14 57; Email: tranier.am@chu-toulouse.fr

Study Locations

• France
  • Toulouse, France, 31059
    • Toulouse University Hospital
    • Contact: Anne-Marie TRANIER; Phone Number: 0567771457; Email: tranier.am@chu-toulouse.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skin discomfort Analogue Visual Scale (AVS)	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	day 11

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction of skin discomfort - 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	day 4
Reduction of skin discomfort - 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	day 30
Variation of erythema and scales severity - VIIS	Variation of erythema and scales severity judged by : - Their intensity, measured with the Visual Index for Ichthyosis Severity (VIIS)	day 4
Variation of erythema and scales severity	Variation of erythema and scales severity judged by : -Their extent, measured with the scores A and B of the Specific Clinical Ichthyosis Score	day 4
Cutaneous pain - day 4	Variation of pain assessed by the Analogue Visual Scale (0-10) of skin pain	day 4
pruritus - day 4	Variation of pruritus assessed by the Analogue Visual Scale (0-10)	day 4
sweating - day 4	Variation of sweating assessed by the Analogue Visual Scale (0-10)	day 4
Cutaneous pain - day 11	Variation of pain assessed by the Analogue Visual scale (0-10) of skin pain	day 11
pruritus - day 11	Variation of pruritus assessed by the Analogue Visual scale (0-10)	day 11
sweating - day 11	Variation of sweating assessed by the Analogue Visual Scale scale (0-10)	day 11
Cutaneous pain - day 30	Variation of pain assessed by the Analogue Visual Scale (0-10) of skin pain	day 30
pruritus - day 30	Variation of pruritus assessed by the Analogue Visual Scale scale (0-10)	day 30
sweating - day 30	Variation of sweating assessed by the Analogue Visual Scale (0-10)	day 30
Feet and scalp discomfort - 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	day 4
Feet and scalp discomfort - 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	day 11
Feet and scalp discomfort - 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	day 30
32-item Ichthyosis Quality of Life questionnaire (IQoL-32)	Variation of patient's quality of life, measured by the ichthyosis specific quality of life questionnaire (IQoL-32)	30 days after treatment

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Anne-Marie TRANIER, University Hospital, Toulouse

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2023
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: July 28, 2023
• First Submitted That Met QC Criteria: July 28, 2023
• First Posted (Actual): August 7, 2023

Study Record Updates

• Last Update Posted (Actual): August 7, 2023
• Last Update Submitted That Met QC Criteria: July 28, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: inherited; Ichthyosis; wraps; skin scales; cutaneous abnormalities
• Additional Relevant MeSH Terms: Skin Diseases; Congenital Abnormalities; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Skin Diseases, Genetic; Skin Abnormalities; Keratosis; Ichthyosiform Erythroderma, Congenital; Ichthyosis; Ichthyosis, Lamellar
• Other Study ID Numbers: RC31/21/0341

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No