Xerotic Dermatitis in Aged People

September 25, 2013 updated by: Pierre Fabre Medical Devices
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

442

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France
        • 0521
      • Angers, France
        • 0523
      • Cugnaux, France
        • 0520
      • Le Fousseret, France
        • 0517
      • Muret, France
        • 0518
      • Muret, France
        • 0519
      • Saint Orens de Gameville, France
        • 0515
      • Saint Orens de Gameville, France
        • 0516
      • Seysses, France
        • 0511
      • Seysses, France
        • 0512
      • Seysses, France
        • 0513
      • Seysses, France
        • 0514
      • Tierce, France
        • 0522
      • Toulouse, France
        • 0501

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
Device: Placebo
Experimental: DC086
cream
Device: DC086

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Itching symptoms intensity change
Time Frame: From Day 1 to 28 days
From Day 1 to 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pierre Fabre Medical Devices

Investigators

  • Principal Investigator: Yves Rolland, Hôpital Purpan CHU TOULOUSE, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

March 6, 2013

First Submitted That Met QC Criteria

March 6, 2013

First Posted (Estimate)

March 7, 2013

Study Record Updates

Last Update Posted (Estimate)

September 26, 2013

Last Update Submitted That Met QC Criteria

September 25, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-A01547-36

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Itching Symptoms

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mozambique

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe