Back to resultsXerotic Dermatitis in Aged People
Primary Purpose
Itching Symptoms, Xerotic Dermatitis
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
DC086
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Itching Symptoms focused on measuring associated, aged population
Eligibility Criteria
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
Sites / Locations
- 0521
- 0523
- 0520
- 0517
- 0518
- 0519
- 0515
- 0516
- 0511
- 0512
- 0513
- 0514
- 0522
- 0501
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
DC086
placebo
Arm Description
cream
Outcomes
Primary Outcome Measures
Itching symptoms intensity change
Secondary Outcome Measures
Full Information
NCT ID
NCT01806935
First Posted
March 6, 2013
Last Updated
September 25, 2013
Sponsor
Pierre Fabre Medical Devices
1. Study Identification
Unique Protocol Identification Number
NCT01806935
Brief Title
Xerotic Dermatitis in Aged People
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pierre Fabre Medical Devices
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Itching Symptoms, Xerotic Dermatitis
Keywords
associated, aged population
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
442 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DC086
Arm Type
Experimental
Arm Description
cream
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Device
Intervention Name(s)
DC086
Intervention Type
Device
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Itching symptoms intensity change
Time Frame
From Day 1 to 28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yves Rolland
Organizational Affiliation
Hôpital Purpan CHU TOULOUSE, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
0521
City
Angers
Country
France
Facility Name
0523
City
Angers
Country
France
Facility Name
0520
City
Cugnaux
Country
France
Facility Name
0517
City
Le Fousseret
Country
France
Facility Name
0518
City
Muret
Country
France
Facility Name
0519
City
Muret
Country
France
Facility Name
0515
City
Saint Orens de Gameville
Country
France
Facility Name
0516
City
Saint Orens de Gameville
Country
France
Facility Name
0511
City
Seysses
Country
France
Facility Name
0512
City
Seysses
Country
France
Facility Name
0513
City
Seysses
Country
France
Facility Name
0514
City
Seysses
Country
France
Facility Name
0522
City
Tierce
Country
France
Facility Name
0501
City
Toulouse
Country
France
12. IPD Sharing Statement
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Xerotic Dermatitis in Aged People
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