- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02749786
Genetic Basis of Rosacea Study (Control)
September 24, 2019 updated by: Anne Chang, Stanford University
Expansion Arm of Papulopustular Rosacea Gene Expression Profiling to Include Normal Individuals as Anatomic Site Specific Controls
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
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Redwood City, California, United States, 94603
- Stanford Dermatology
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Control Group
Participants who do not have rosacea (control group)
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Skin biopsies will be performed via the Keys punch technique from normal facial skin.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Gene expression profile of papulopustular rosacea compared to normal skin and skin from individuals without rosacea.
Time Frame: Up to 2 years
|
Up to 2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Anne Chang, Stanford University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 21, 2016
Primary Completion (Actual)
August 1, 2016
Study Completion (Actual)
August 1, 2016
Study Registration Dates
First Submitted
April 18, 2016
First Submitted That Met QC Criteria
April 20, 2016
First Posted (Estimate)
April 25, 2016
Study Record Updates
Last Update Posted (Actual)
September 26, 2019
Last Update Submitted That Met QC Criteria
September 24, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22419
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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