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

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ClinicalTrials.gov Identifier: NCT05979506
Recruitment Status : Not yet recruiting
First Posted : August 7, 2023
Last Update Posted : November 24, 2023
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

Study Description
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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.

Condition or disease Intervention/treatment Phase
Ichthyosis Inherited Procedure: Cutaneous wraps Not Applicable

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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)
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
Estimated Study Start Date : January 31, 2024
Estimated Primary Completion Date : April 1, 2025
Estimated Study Completion Date : April 1, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. Skin discomfort Analogue Visual Scale (AVS) [ Time Frame: 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 :
  1. Reduction of skin discomfort - day 4 [ Time Frame: 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

  2. Reduction of skin discomfort - day 30 [ Time Frame: 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

  3. Variation of erythema and scales severity - VIIS [ Time Frame: day 4 ]

    Variation of erythema and scales severity judged by :

    - Their intensity, measured with the Visual Index for Ichthyosis Severity (VIIS)


  4. Variation of erythema and scales severity [ Time Frame: 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


  5. Cutaneous pain - day 4 [ Time Frame: day 4 ]
    Variation of pain assessed by the Analogue Visual Scale (0-10) of skin pain

  6. pruritus - day 4 [ Time Frame: day 4 ]
    Variation of pruritus assessed by the Analogue Visual Scale (0-10)

  7. sweating - day 4 [ Time Frame: day 4 ]
    Variation of sweating assessed by the Analogue Visual Scale (0-10)

  8. Cutaneous pain - day 11 [ Time Frame: day 11 ]
    Variation of pain assessed by the Analogue Visual scale (0-10) of skin pain

  9. pruritus - day 11 [ Time Frame: day 11 ]
    Variation of pruritus assessed by the Analogue Visual scale (0-10)

  10. sweating - day 11 [ Time Frame: day 11 ]
    Variation of sweating assessed by the Analogue Visual Scale scale (0-10)

  11. Cutaneous pain - day 30 [ Time Frame: day 30 ]
    Variation of pain assessed by the Analogue Visual Scale (0-10) of skin pain

  12. pruritus - day 30 [ Time Frame: day 30 ]
    Variation of pruritus assessed by the Analogue Visual Scale scale (0-10)

  13. sweating - day 30 [ Time Frame: day 30 ]
    Variation of sweating assessed by the Analogue Visual Scale (0-10)

  14. Feet and scalp discomfort - day 4 [ Time Frame: 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

  15. Feet and scalp discomfort - day 11 [ Time Frame: 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

  16. Feet and scalp discomfort - day 30 [ Time Frame: 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

  17. 32-item Ichthyosis Quality of Life questionnaire (IQoL-32) [ Time Frame: 30 days after treatment ]
    Variation of patient's quality of life, measured by the ichthyosis specific quality of life questionnaire (IQoL-32)


Eligibility Criteria
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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05979506


Contacts
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Contact: Anne-Marie TRANIER 05 67 77 14 57 tranier.am@chu-toulouse.fr

Locations
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France
Toulouse University hospital
Toulouse, France, 31059
Contact: Anne-Marie TRANIER    0567771457    tranier.am@chu-toulouse.fr   
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
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Principal Investigator: Anne-Marie TRANIER University Hospital, Toulouse
More Information
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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT05979506    
Other Study ID Numbers: RC31/21/0341
First Posted: August 7, 2023    Key Record Dates
Last Update Posted: November 24, 2023
Last Verified: November 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Toulouse:
Ichthyosis
inherited
wraps
skin scales
cutaneous abnormalities
Additional relevant MeSH terms:
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Ichthyosis
Ichthyosis, Lamellar
Skin Abnormalities
Congenital Abnormalities
Infant, Newborn, Diseases
 Keratosis
Skin Diseases
Ichthyosiform Erythroderma, Congenital
Skin Diseases, Genetic
Genetic Diseases, Inborn