Itching Symptoms Clinical Trial
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
| Status | Completed |
| Enrollment | 442 |
| Est. completion date | September 2013 |
| Est. primary completion date | September 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 70 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| France | 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 | Tierce | |
| France | 0501 | Toulouse |
| Lead Sponsor | Collaborator |
|---|---|
| Pierre Fabre Medical Devices |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Itching symptoms intensity change | From Day 1 to 28 days | No |