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Genetic Basis of Rosacea

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02787616
Recruitment Status : Completed
First Posted : June 1, 2016
Last Update Posted : September 26, 2019
Sponsor:
Information provided by (Responsible Party):
Anne Chang, Stanford University

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.

Condition or disease Intervention/treatment
Rosacea Genetic: buccal swab

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Study Type : Observational
Actual Enrollment : 306 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Validation of Candidate Rosacea Genes By Targeted Interrogation of Alleles and Assessment of Rosacea Co-morbidities
Actual Study Start Date : April 13, 2012
Actual Primary Completion Date : November 16, 2018
Actual Study Completion Date : November 16, 2018

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Rosacea
MedlinePlus related topics: Rosacea

Group/Cohort Intervention/treatment
Rosacea Group Genetic: buccal swab
cheek swab for DNA sampling

Non-Rosacea Group Genetic: buccal swab
cheek swab for DNA sampling




Primary Outcome Measures :
  1. Targeted interrogation of alleles and assessment of rosacea co-morbidities. [ Time Frame: Up to 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
300 individuals will be enrolled, 150 with dermatologist verified rosacea and 150 without rosacea.
Criteria

Eligibility Criteria for Rosacea Group:

Inclusion criteria for rosacea participants:

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

Exclusion criteria for rosacea participants:

  1. Unable or unwilling to provide written informed consent
  2. Concomitant facial or medical condition that obscures diagnosis of rosacea (such as malar erythema from lupus erythematosus)
  3. Acne vulgaris
  4. Unable or unwilling to provide peripheral blood sample (a few teaspoons)
  5. 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.)
  6. Use of topical prescription medications or procedures to the face within one month of enrollment
  7. Women who are pregnant or lactating

Eligibility Criteria for Non-Rosacea Group:

Inclusion criteria for control participants:

  1. No history of rosacea
  2. No clinical signs or symptoms of rosacea
  3. No family history of rosacea
  4. All four grandparents of European descent
  5. Fitzpatrick skin type I or II
  6. Age 18 years or older

Exclusion criteria for control participants:

  1. Unable or unwilling to provide written informed consent
  2. Acne vulgaris
  3. Unable or unwilling to provide peripheral blood sample (a few teaspoons)
  4. Women who are pregnant or lactating
  5. Use of topical prescription medications or procedures to the face within one month of enrollment
  6. Skin conditions that might interfere with interpretation of procedure results (at the discretion of the investigator)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02787616


Locations
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United States, California
Stanford Dermatology
Redwood City, California, United States, 94603
Sponsors and Collaborators
Stanford University
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Responsible Party: Anne Chang, Associate Professor of Dermatology, Stanford University
ClinicalTrials.gov Identifier: NCT02787616    
Other Study ID Numbers: R15006
First Posted: June 1, 2016    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019
Additional relevant MeSH terms:
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Rosacea
Skin Diseases