Rosacea Prevalence in General Population - Pilot Study

November 13, 2014 updated by: Galderma R&D
The purpose of this study is to test and refine, a subject questionnaire aimed to be used in a general population rosacea prevalence study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study will test the subject questionnaire aimed to be used in a full general population prevalence study to screen potential subjects with rosacea.

Questionnaire will be self-administrated to Dermatology outpatients.

Testing will be performed at the practice of 2 Dermatologists experts in rosacea who will evaluate subjects' answers and propose fine-tuning of the questionnaire content, if needed.

Study Type

Observational

Enrollment (Actual)

120

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

  • Canada
    • Ontario
      • Windsor, Ontario, Canada, N8W 5L7
        • Jerry TAN
  • Sweden
      • Eskilstuna, Sweden, S-631 88
        • Mats BERG

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Rosacea and non-rosacea patients

Description

  • Male or Female aged between 18 (or locally accepted majority) and 65 years old both included.
  • Subject visiting one of the study dermatology practices for daily care/routine dermatology consultation.
  • Subject have to read and sign the approved Informed Consent form prior to any participation in the study,
  • Subject willing and capable of cooperating to the extend and degree required by the protocol

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
rosacea patients
Questionnaire testing on routine dermatologist patient population
Other: Questionnaire testing
Questionnaire testing on rosacea and non-rosacea dermatology outpatients
non-rosacea patients
Questionnaire testing on routine dermatologist patient population
Other: Questionnaire testing
Questionnaire testing on rosacea and non-rosacea dermatology outpatients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sensitivity and specificity of questions
Time Frame: Day 1

sensitivity and specificity of each questionnaire key items by comparing subject answers and investigator assessments, as follows: Sensitivity= True Positive/(True Positive+False Negative)

Specificity= True Negative/ (False Positive+True Negative)
Day 1

Collaborators and Investigators

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

Sponsor

Galderma R&D

Investigators

  • Study Director: Fabien AUDIBERT, Bsc, Galderma R&D

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

August 1, 2012

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

October 14, 2014

First Submitted That Met QC Criteria

November 13, 2014

First Posted (Estimate)

November 17, 2014

Study Record Updates

Last Update Posted (Estimate)

November 17, 2014

Last Update Submitted That Met QC Criteria

November 13, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RD.03.SPR.29105

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.

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