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
About this trial
This is an interventional diagnostic trial for Rosacea
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)
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
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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