Assessment of the Rosacea Prevalence in the General Population (RISE)

Assessment of the Prevalence of Rosacea in the General Population

Multi-centre interventional cross-sectional prevalence study Assessment of the Rosacea Prevalence in the General Population.

Study Overview

• Status: Completed
• Conditions: Rosacea
• Intervention / Treatment: Other: Prevalence assessment

Detailed Description

Primary objective:

Assessment of the prevalence of rosacea in the general population per country using subject questionnaire and dermatologist diagnosis

• Study Type: Observational
• Enrollment (Actual): 6000

Participation Criteria

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: Probability Sample

Study Population

Part I:

Subjects will be screened from the general population by questionnaires mainly focusing on detection of signs and symptoms of rosacea.

Subjects' answers will be submitted to a pre-defined algorithm to identify the potential subjects with rosacea (screened positive for rosacea, Screened R+).

Part II:

A subgroup of subjects (100 maximum per country) will be randomly selected among those who screened positive for rosacea and will be referred to the closest investigational site (dermatologist practice).

Description

Part I

Inclusion Criteria:

The following subjects will be included in the study:

• Subjects aged 18 to 65 years old from the general population
• Subjects who are willing to complete the questionnaires

Part II

Inclusion Criteria:

The following subjects will be included in Part II of the study:

• Subjects who screened positive for rosacea during the first part of the study and selected by random method
• Subjects who gave their informed consent to participate in Part II of the study

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
percentage of subjects with rosacea diagnosis confirmed	estimation of the percentage of rosacea patients in the general population	general population will be surveyed over an expected average duration of 6 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): February 1, 2014
• Study Completion (Actual): February 1, 2014

Study Registration Dates

• First Submitted: October 14, 2014
• First Submitted That Met QC Criteria: November 14, 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 14, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Rosacea
• Other Study ID Numbers: RD.03.SPR.29104