Status:
COMPLETED
Xerotic Dermatitis in Aged People
Lead Sponsor:
Pierre Fabre Medical Devices
Conditions:
Itching Symptoms
Xerotic Dermatitis
Eligibility:
All Genders
70+ years
Phase:
NA
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
Eligibility Criteria
Inclusion
- 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 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
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
442 Patients enrolled
Trial Details
Trial ID
NCT01806935
Start Date
April 1 2013
End Date
September 1 2013
Last Update
September 26 2013
Active Locations (14)
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1
0521
Angers, France
2
0523
Angers, France
3
0520
Cugnaux, France
4
0517
Le Fousseret, France