Ichthyosis InheritedNCT05979506
Evaluate the Evolution of Body and Scalp Skin Discomfort in Patients With Hereditary Ichthyosis After Wraps (EnvelopIchtyose)
A study testing Cutaneous wraps in people with Ichthyosis Inherited, run by University Hospital, Toulouse at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Ichthyosis Inherited
- What is being tested?
- Cutaneous wraps
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteFrance
- Study dates
- 2 Feb 2024to 10 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
RASMUS Lysa contact
France1 site, 1 recruiting
- Recruiting
Toulouse University hospital
Toulouse, 31059
Lysa RASMUS, 0567771457, rasmus.l@chu-toulouse.fr
About this study
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
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.
Read the 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
- Conditions
- Ichthyosis Inherited
- Being tested
- Cutaneous wraps
- Keywords
- Ichthyosis, inherited, wraps, skin scales, cutaneous abnormalities
- Medical subject headings
- Ichthyosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cutaneous wrapsProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Procedure: Cutaneous wraps |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: day 11
Secondary outcomes (17)
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
Measured: 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
Measured: day 30
Variation of erythema and scales severity - Visual Index for Ichthyosis Severity
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
Measured: 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
Measured: day 4
Cutaneous pain - day 4
Variation of pain assessed by the Analogue Visual Scale (0-10) of skin pain
Measured: day 4
pruritus - day 4
Variation of pruritus assessed by the Analogue Visual Scale (0-10)
Measured: day 4
sweating - day 4
Variation of sweating assessed by the Analogue Visual Scale (0-10)
Measured: day 4
Cutaneous pain - day 11
Variation of pain assessed by the Analogue Visual scale (0-10) of skin pain
Measured: day 11
pruritus - day 11
Variation of pruritus assessed by the Analogue Visual scale (0-10)
Measured: day 11
sweating - day 11
Variation of sweating assessed by the Analogue Visual Scale scale (0-10)
Measured: day 11
Cutaneous pain - day 30
Variation of pain assessed by the Analogue Visual Scale (0-10) of skin pain
Measured: day 30
pruritus - day 30
Variation of pruritus assessed by the Analogue Visual Scale scale (0-10)
Measured: day 30
sweating - day 30
Variation of sweating assessed by the Analogue Visual Scale (0-10)
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 30 days after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2023
- Study start2 Feb 2024
- Primary completion10 Oct 2026 (estimated)
- Study completion10 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ichthyosis InheritedStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Interventional, prospective, multicenter (Toulouse - Bordeaux - Paris Necker), comparative (baseline vs. short and medium term)
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne-Marie TRANIER, Principal investigator, University Hospital, ToulouseLysa RASMUS, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05979506
- Sponsor's protocol ID
- RC31/21/0341
- Status last verified
- Apr 2026
- First submitted
- 28 Jul 2023
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05979506
- Acronym / sponsor ID
- RC31/21/0341
- Conditions
- Ichthyosis Inherited
- Keywords
- Ichthyosis, inherited, wraps, skin scales, cutaneous abnormalities
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 2 Feb 2024 (actual)
- Primary completion
- 10 Oct 2026 (estimated)
- Study completion
- 10 Oct 2026 (estimated)
- First posted
- 7 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Interventional, prospective, multicenter (Toulouse - Bordeaux - Paris Necker), comparative (baseline vs. short and medium term)
| Arm | Type | Receives |
|---|---|---|
| Wraps (body and feet) as well as scalp care | Experimental | Procedure: Cutaneous wrapsThe 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). |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cutaneous wrapsThe 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 | Procedure or surgery | Wraps (body and feet) as well as scalp care |
Primary outcome
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
17 secondary outcomes
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
sweating - day 30
Time frame: day 30
Feet and scalp discomfort - day 4
Time frame: day 4
Feet and scalp discomfort - day 11
Time frame: day 11
Feet and scalp discomfort - day 30
Time frame: day 30
32-item Ichthyosis Quality of Life questionnaire (IQoL-32)
Time frame: 30 days after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
RASMUS Lysa contact
Anne-Marie TRANIER principal investigator
University Hospital, Toulouse
Lysa RASMUS principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cutaneous wraps in people with Ichthyosis Inherited, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anne-Marie TRANIER (05 67 77 14 57, tranier.am@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin discomfort Analogue Visual Scale (AVS) (time frame: day 11). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.