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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age15+
SponsorUniversity Hospital, Toulouse

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Cutaneous wraps

    Procedure/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

Treatment groups

34 Participants
are divided into 1 treatment group
Group A: Wraps (body and feet) as well as scalp careExperimental treatment 1 intervention

Trial outcomes

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

Time frame
day 11

Secondary outcomes

1

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

Time frame
day 4
2

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

Time frame
day 30
3

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

Time frame
day 4
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

Time frame
day 4

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.