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Genetic Basis of Rosacea Study (Control)

Primary Purpose

Rosacea

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Skin Biopsy
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Rosacea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria include:

  1. Fitzpatrick skin type II or III
  2. Age greater than or equal to 18 years
  3. Individuals without a history of rosacea

Exclusion criteria include:

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

Sites / Locations

  • Stanford Dermatology

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Control Group

Arm Description

Participants who do not have rosacea (control group)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 18, 2016
Last Updated
September 24, 2019
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT02749786
Brief Title
Genetic Basis of Rosacea Study (Control)
Official Title
Expansion Arm of Papulopustular Rosacea Gene Expression Profiling to Include Normal Individuals as Anatomic Site Specific Controls
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
January 21, 2016 (Actual)
Primary Completion Date
August 1, 2016 (Actual)
Study Completion Date
August 1, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rosacea

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Other
Arm Description
Participants who do not have rosacea (control group)
Intervention Type
Other
Intervention Name(s)
Skin Biopsy
Intervention Description
Skin biopsies will be performed via the Keys punch technique from normal facial skin.
Primary Outcome Measure Information:
Title
Gene expression profile of papulopustular rosacea compared to normal skin and skin from individuals without rosacea.
Time Frame
Up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria include: Fitzpatrick skin type II or III Age greater than or equal to 18 years Individuals without a history of rosacea Exclusion criteria include: 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Chang
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford Dermatology
City
Redwood City
State/Province
California
ZIP/Postal Code
94603
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Genetic Basis of Rosacea Study (Control)

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