Toulouse University hospital
Toulouse, 31059, France
Location status: Recruiting
NCT Number: NCT05979506
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.
Interested in participating?
Request Info15 year and older
All sexes
Interventional
Not applicable
Toulouse, 31059, France
Location status: Recruiting
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The topical treatment that will be used in this study are:
Each of the 3 treatments (body, scalp and feet) will be carried out as follows:
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
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
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
Time frame: day 4
Variation of erythema and scales severity judged by :
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
Time frame: day 4
Variation of pain assessed by the Analogue Visual Scale (0-10) of skin pain
Time frame: day 4
Variation of pruritus assessed by the Analogue Visual Scale (0-10)
Time frame: day 4
Variation of sweating assessed by the Analogue Visual Scale (0-10)
Time frame: day 11
Variation of pain assessed by the Analogue Visual scale (0-10) of skin pain
Time frame: day 11
Variation of pruritus assessed by the Analogue Visual scale (0-10)
Time frame: day 11
Variation of sweating assessed by the Analogue Visual Scale scale (0-10)
Time frame: day 30
Variation of pain assessed by the Analogue Visual Scale (0-10) of skin pain
Time frame: day 30
Variation of pruritus assessed by the Analogue Visual Scale scale (0-10)
Time frame: day 30
Variation of sweating assessed by the Analogue Visual Scale (0-10)
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
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
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
Time frame: 30 days after treatment
Variation of patient's quality of life, measured by the ichthyosis specific quality of life questionnaire (IQoL-32)
Contact information is provided by the study sponsor or research team.
University Hospital, Toulouse
Other
Evaluate the Evolution of Cutaneous Discomfort of the Body and Scalp After 3 Wraps, in Patients With Moderate to Very Severe Hereditary Ichthyosis
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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.
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