Itching Symptoms, Xerotic Dermatitis
Conditions
Keywords
associated, aged population
Brief summary
The purpose of the study is to assess the the effect of the study product on itching symptoms associated with xerotic dermatitis in aged population
Interventions
DEVICEDC086
DEVICEPlacebo
Sponsors
Pierre Fabre Medical Devices
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged from 70 years * With xerotic dermatitis, clinically assessed , * At least on the anterior part of lower and/or upper limbs, * Presenting itching xerotic dermatitis evolving from at least 3 weeks * Intensity of itching ≥ 4 on VAS (0-10) at th inclusion time * With MMSE score ≥ 20 dating less than 6 months * Affiliated to a social security system, or is a beneficiary (as applicable in the national regulation)
Exclusion criteria
* Criteria related to pathologies * Severe form of other dermatitis requiring either systemic treatment \-- Itching xerotic dermatitis from iatrogenic origins * Dermatological disease other than xerotic dermatitis which could interfere with the assessment, * Systemic disease that may generate xerotic dermatitis and /or pruritus * Immunosuppression condition, * History of serious disease considered by the investigator hazardous for the patient or incompatible with the study. * Criteria related to treatment \- Use of treatment which could interfere with the evaluation of the disease or the course of the disease * Criteria related to the population * Ongoing participation to another clinical trial or participation in the previous month before the inclusion * Patient under guardianship or trusteeship
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Itching symptoms intensity change | From Day 1 to 28 days |
Countries
France
Outcome results
None listed