NCT02292797

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

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

Enrollment
6,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2013

Shorter than P25 for all trials

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

September 1, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
9 months 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

5 months

First QC Date

October 14, 2014

Last Update Submit

November 14, 2014

Conditions

Rosacea

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

Prevalence assessmentOTHER

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

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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).

You may qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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

September 1, 2013

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

November 17, 2014

Record last verified: 2014-11