Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05979506

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Toulouse University hospital

Toulouse, 31059, France

Location status: Recruiting

Location contact

Lysa RASMUS

CONTACT

[email protected]

0567771457

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cutaneous wraps

Procedure

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

Primary outcomes

  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 outcomes

  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 - Visual Index for Ichthyosis Severity

    Time frame: day 4

    Variation of erythema and scales severity judged by :

    • Their intensity, measured with the Visual Index for Ichthyosis Severity (VIIS) : scores scored separately out of 16. The 16 point scorring is : 4 zones: upper back, upper arm, lower legs, top of foot, scored out of 4 with 0 = no lesions, 1 = areas of normal skin with small scales, 2 = confluent smoothing, 3 = confluent scales and 4 = confluent scale
  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)

Study contacts

Contact information is provided by the study sponsor or research team.

Anne-Marie TRANIER

CONTACT

[email protected]

05 67 77 14 57

RASMUS Lysa

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 7, 2023
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.