Evaluate the Evolution of Body and Scalp Skin Discomfort in Patients With Hereditary Ichthyosis After Wraps (EnvelopIchtyose)
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In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cutaneous wraps.
- Who it may be relevant to
- Registry conditions: Ichthyosis Inherited. Basic parameters: from 15 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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
Interventions
- 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 pati
Primary outcome measures
- Skin discomfort Analogue Visual Scale (AVS) [Time frame: day 11]
Secondary outcome measures (12)
- Reduction of skin discomfort - day 4 [Time frame: day 4]
- Reduction of skin discomfort - day 30 [Time frame: day 30]
- Variation of erythema and scales severity - Visual Index for Ichthyosis Severity [Time frame: day 4]
- Variation of erythema and scales severity [Time frame: day 4]
- Cutaneous pain - day 4 [Time frame: day 4]
- pruritus - day 4 [Time frame: day 4]
- sweating - day 4 [Time frame: day 4]
- Cutaneous pain - day 11 [Time frame: day 11]
- pruritus - day 11 [Time frame: day 11]
- sweating - day 11 [Time frame: day 11]
- Cutaneous pain - day 30 [Time frame: day 30]
- pruritus - day 30 [Time frame: day 30]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
France · 1 center
- Toulouse University hospital — Toulouse
Identifiers
NCT: NCT05979506 · RC31/21/0341