NCT Number: NCT01806935
Xerotic Dermatitis in Aged People
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
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Conditions
Age range
70 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
0521, Angers, France
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
PLACEBO
DevicePrimary outcomes
-
Itching symptoms intensity change
Time frame: From Day 1 to 28 days
Sponsors and collaborators
Lead sponsor
Pierre Fabre Medical Devices
Industry
Registry information
Important dates
- Study start
- 2013
- Primary completion
- 2013
- Study completion
- 2013
- First posted
- Mar 7, 2013
- Registry last updated
- Sep 26, 2013
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
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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