NCT02749786

Brief Summary

Rosacea is a common disease characterized by inflammation and vascular abnormalities of the facial skin and ocular surface. It it considered to be a syndrome encompassing various combinations of cutaneous signs including flushing, erythema, telangiectasia, papules, edema, ocular lesions, and rhinophyma. The exact etiology of cutaneous rosacea is unknown but is characterized by persistent vasodilation, increased vascular permeability, and vascular hyper-reactivity of the microcirculation of the central part of the face. The purpose of this study is to develop gene expression profiles of papulopustular rosacea compared to those of normal skin. The investigator hopes 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
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2016

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 21, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 18, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 25, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

September 26, 2019

Status Verified

September 1, 2019

Enrollment Period

6 months

First QC Date

April 18, 2016

Last Update Submit

September 24, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Gene expression profile of papulopustular rosacea compared to normal skin and skin from individuals without rosacea.

    Up to 2 years

Study Arms (1)

Control Group

OTHER

Participants who do not have rosacea (control group)

Other: Skin Biopsy

Interventions

Skin biopsies will be performed via the Keys punch technique from normal facial skin.

Control Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Fitzpatrick skin type II or III
  • Age greater than or equal to 18 years
  • Individuals without a history of rosacea

You may not qualify if:

  • Women who are pregnant or lactating
  • Use of topical prescription medications or procedures to the face within one month of enrollment
  • Skin conditions that might interfere with interpretation of procedure results (at the discretion of the investigator)

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 Officials

  • Anne Chang

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Dermatology

Study Record Dates

First Submitted

April 18, 2016

First Posted

April 25, 2016

Study Start

January 21, 2016

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

September 26, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations