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

NCT05979506 | Recruiting

• 1 other identifier: RC31/21/0341
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Ichthyosis Inherited

Keywords

Ichthyosis; inherited; wraps; skin scales; cutaneous abnormalities

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (17)

• Reduction of skin discomfort - day 4

  day 4

• Reduction of skin discomfort - day 30

  day 30

• Variation of erythema and scales severity - Visual Index for Ichthyosis Severity

  day 4

• Variation of erythema and scales severity

  day 4

• Cutaneous pain - day 4

  day 4

Study Arms (1)

Wraps (body and feet) as well as scalp care

EXPERIMENTAL

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

Interventions

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

Wraps (body and feet) as well as scalp care

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patient with a skin disease other than ichthyosis
• 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

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

Toulouse University hospital

Toulouse, 31059, France

RECRUITING

MeSH Terms

Conditions

Ichthyosis

Condition Hierarchy (Ancestors)

Skin Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Anne-Marie TRANIER

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

• Lysa RASMUS

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne-Marie TRANIER

CONTACT

05 67 77 14 57; tranier.am@chu-toulouse.fr

RASMUS Lysa

CONTACT

rasmus.l@chu-toulouse.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: July 28, 2023
• First Posted: August 7, 2023
• Study Start: February 2, 2024
• Primary Completion (Estimated): October 10, 2026
• Study Completion (Estimated): October 10, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)