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NCT02292836 Clinical Trial

Rosacea Prevalence in General Population - Pilot Study

Rosacea Clinical Trial

Official title:
Rosacea Prevalence in General Population - Pilot Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02292836
Other study ID # RD.03.SPR.29105
Secondary ID
Status Completed
Phase N/A
First received October 14, 2014
Last updated November 13, 2014
Start date August 2012
Est. completion date February 2013

Study information
Verified date November 2014
Source Galderma
Contact n/a
Is FDA regulated No
Health authority France: Commission nationale de l'informatique et des libertés
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 120
Est. completion date February 2013
Est. primary completion date February 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility - 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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Other:
• Questionnaire testing
Questionnaire testing on rosacea and non-rosacea dermatology outpatients

Locations
Country Name City State
Canada Jerry TAN Windsor Ontario
Sweden Mats BERG Eskilstuna

Sponsors (1)
Lead Sponsor Collaborator
Galderma

Countries where clinical trial is conducted

Canada,  Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 No
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