NCT02787616

Brief Summary

Rosacea is a common disease characterized by inflammation and vascular abnormalities of the facial skin and ocular surface. The exact pathogenesis of papulopustular rosacea is not well understood and current methods to treat this disease are often unsatisfactory. The purpose of this study is to develop gene expression profiles of papulopustular rosacea compared to those of normal skin. The investigators hope to better understand the abnormal gene functions that might contribute to this condition. This understanding may lead to the development of additional and better treatments for rosacea.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
306

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

April 13, 2012

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

April 18, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 1, 2016

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 16, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 16, 2018

Completed
Last Updated

September 26, 2019

Status Verified

September 1, 2019

Enrollment Period

6.6 years

First QC Date

April 18, 2016

Last Update Submit

September 24, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Targeted interrogation of alleles and assessment of rosacea co-morbidities.

    Up to 2 years

Study Arms (2)

Rosacea Group

Genetic: buccal swab

Non-Rosacea Group

Genetic: buccal swab

Interventions

cheek swab for DNA sampling

Non-Rosacea GroupRosacea Group

Eligibility Criteria

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

300 individuals will be enrolled, 150 with dermatologist verified rosacea and 150 without rosacea.

You may qualify if:

  • Clinical signs and symptoms of rosacea (papulopustular or erythrotelangiectatic subtypes) present at enrollment as determined by the investigator
  • All four grandparents of European descent
  • Fitzpatrick skin type I or II
  • Age 18 years or older

You may not qualify if:

  • Unable or unwilling to provide written informed consent
  • Concomitant facial or medical condition that obscures diagnosis of rosacea (such as malar erythema from lupus erythematosus)
  • Acne vulgaris
  • Unable or unwilling to provide peripheral blood sample (a few teaspoons)
  • Inability for investigator to verify rosacea diagnosis on clinical examination due to rosacea treatment(s) leading to complete lack of signs and symptoms (such prior laser treatments, systemic tetracycline usage, etc.)
  • Use of topical prescription medications or procedures to the face within one month of enrollment
  • Women who are pregnant or lactating
  • Eligibility Criteria for Non-Rosacea Group:
  • No history of rosacea
  • No clinical signs or symptoms of rosacea
  • No family history of rosacea
  • All four grandparents of European descent
  • Fitzpatrick skin type I or II
  • Age 18 years or older
  • Unable or unwilling to provide written informed consent
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford Dermatology

Redwood City, California, 94603, United States

Location

MeSH Terms

Conditions

Rosacea

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Dermatology

Study Record Dates

First Submitted

April 18, 2016

First Posted

June 1, 2016

Study Start

April 13, 2012

Primary Completion

November 16, 2018

Study Completion

November 16, 2018

Last Updated

September 26, 2019

Record last verified: 2019-09

Locations