Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
442 participants
INTERVENTIONAL
2013-04-30
2013-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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DC086
cream
DC086
placebo
Placebo
Interventions
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DC086
Placebo
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
70 Years
ALL
No
Sponsors
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Pierre Fabre Medical Devices
INDUSTRY
Responsible Party
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Principal Investigators
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Yves Rolland
Role: PRINCIPAL_INVESTIGATOR
Hôpital Purpan CHU TOULOUSE, France
Locations
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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
Countries
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Other Identifiers
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2012-A01547-36
Identifier Type: -
Identifier Source: org_study_id