Xerotic Dermatitis in Aged People

Not Applicable

Completed

• Conditions: Itching Symptoms; Xerotic Dermatitis
• Interventions: Device: DC086; Device: Placebo

• Registration Number: NCT01806935
• Lead Sponsor: Pierre Fabre Medical Devices

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2013-02
• Study First Submitted: 2013-03-06
• Study First Submitted QC: 2013-03-06
• Study First Posted: 2013-03-07
• Study Start: 2013-04
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Last Update Submitted: 2013-09-25
• Last Update Posted: 2013-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 442

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DC086	DC086	cream
placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Itching symptoms intensity change	From Day 1 to 28 days

Trial Locations

Locations (14)

0523; 🇫🇷 Angers, France

0515; 🇫🇷 Saint Orens de Gameville, France

0501; 🇫🇷 Toulouse, France

0521; 🇫🇷 Angers, France

0517; 🇫🇷 Le Fousseret, France

0512; 🇫🇷 Seysses, France

0514; 🇫🇷 Seysses, France

0522; 🇫🇷 Tierce, France

0520; 🇫🇷 Cugnaux, France

0519; 🇫🇷 Muret, France

0518; 🇫🇷 Muret, France

0511; 🇫🇷 Seysses, France

0513; 🇫🇷 Seysses, France

0516; 🇫🇷 Saint Orens de Gameville, France