Genetic Basis of Rosacea

Rosacea Clinical Trial

Official title:

Validation of Candidate Rosacea Genes By Targeted Interrogation of Alleles and Assessment of Rosacea Co-morbidities

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02787616
• Other study ID #: R15006
• Status: Completed
• Start date: April 13, 2012
• Est. completion date: November 16, 2018

Study information

• Verified date: September 2019
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 306
• Est. completion date: November 16, 2018
• Est. primary completion date: November 16, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Rosacea

Intervention

Genetic:
• buccal swab
cheek swab for DNA sampling

Locations

Country	Name	City	State
United States	Stanford Dermatology	Redwood City	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Targeted interrogation of alleles and assessment of rosacea co-morbidities.		Up to 2 years