NCT02292836

Brief Summary

The purpose of this study is to test and refine, a subject questionnaire aimed to be used in a general population rosacea prevalence study.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2012

Shorter than P25 for all trials

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

October 14, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 17, 2014

Completed
Last Updated

November 17, 2014

Status Verified

November 1, 2014

Enrollment Period

6 months

First QC Date

October 14, 2014

Last Update Submit

November 13, 2014

Conditions

Rosacea

Outcome Measures

Primary Outcomes (1)

  • sensitivity and specificity of questions

    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

Study Arms (2)

rosacea patients

Questionnaire testing on routine dermatologist patient population

Other: Questionnaire testing

non-rosacea patients

Questionnaire testing on routine dermatologist patient population

Other: Questionnaire testing

Interventions

Questionnaire testingOTHER

Questionnaire testing on rosacea and non-rosacea dermatology outpatients

non-rosacea patientsrosacea patients

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Rosacea and non-rosacea patients

* 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Jerry TAN

Windsor, Ontario, N8W 5L7, Canada

Location

Mats BERG

Eskilstuna, S-631 88, Sweden

Location

MeSH Terms

Conditions

Rosacea

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Fabien AUDIBERT, Bsc

    Galderma R&D

    STUDY DIRECTOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2014

First Posted

November 17, 2014

Study Start

August 1, 2012

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

November 17, 2014

Record last verified: 2014-11

Locations

SE(1)CA(1)