Xerotic Dermatitis in Aged People
1 other identifier
interventional
442
1 country
14
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2013
Shorter than P25 for not_applicable
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 6, 2013
CompletedFirst Posted
Study publicly available on registry
March 7, 2013
CompletedStudy Start
First participant enrolled
April 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedSeptember 26, 2013
February 1, 2013
5 months
March 6, 2013
September 25, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Itching symptoms intensity change
From Day 1 to 28 days
Study Arms (2)
DC086
EXPERIMENTALcream
placebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
- 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)
You may not qualify if:
- 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
- Patient under guardianship or trusteeship
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
0521
Angers, France
0523
Angers, France
0520
Cugnaux, France
0517
Le Fousseret, France
0518
Muret, France
0519
Muret, France
0515
Saint-Orens-de-Gameville, France
0516
Saint-Orens-de-Gameville, France
0511
Seysses, France
0512
Seysses, France
0513
Seysses, France
0514
Seysses, France
0522
Tiercé, France
0501
Toulouse, France
Study Officials
- PRINCIPAL INVESTIGATOR
Yves Rolland
Hôpital Purpan CHU TOULOUSE, France
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 6, 2013
First Posted
March 7, 2013
Study Start
April 1, 2013
Primary Completion
September 1, 2013
Study Completion
September 1, 2013
Last Updated
September 26, 2013
Record last verified: 2013-02