Characterization of the Facial and Gut Microbiome in Rosacea

Characterization of the Facial and Gut Microbiome in Identical and Fraternal Twins With Rosacea; Comparison to Healthy Controls

Questionnaires will be completed by each member of the twin set. A board-certified dermatologist will examine each member to categorize the type and severity of their rosacea. The facial and gut microbiome will be sampled and sent for microbial analysis.

Study Overview

• Status: Unknown
• Conditions: Rosacea
• Intervention / Treatment: Other: comparison of twin A to twin B

Detailed Description

1. Twin set subjects will be administered a questionnaire regarding demographics (age, gender, state of residence, time lived together, birth order), rosacea duration, prior rosacea treatment, diet (and similarity of diet to twin), co-morbidities, signs and symptoms suggestive of cardiovascular or gastrointestinal disease/disorder.
2. Subjects will be examined by a board-certified dermatologist and global assessment, inflammatory counts and clinician's erythema score will be performed. Eyes will be examined for signs of ocular rosacea.
3. Facial microbiome sampling will be performed on-site utilizing a kit manufactured by UBiome. The skin with active rosacea will be swabbed and the swab immediately placed in sample medium. The tube is then shipped to the manufacturer for 16s rRNA shotgun metagenomics to identify resident bacterial genera and species. (16) This can be compared to their extensive library of normal controls, to the other member of the twin set and to acne subjects.
4. Subjects will be given a fecal microbiome kit for home sampling. Feces obtained from toilet paper is collected and placed in the sample medium. Subjects can either ship directly or return to the study site for shipping.

• Study Type: Observational
• Enrollment (Anticipated): 150

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Attendees at the Twins Days Festival Monozygotic or dizygotic twin sets Facial Rosacea

Description

Inclusion Criteria:

1. Presenting with monozygotic or dizygotic twin
2. One or both twins with facial rosacea
3. Willingness to allow facial and fecal samples to be analyzed -

Exclusion Criteria:

1. Non-twin siblings
2. Absence of facial rosacea in both twins -

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
twin A; Sampling of the facial and fecal microbiome	Other: comparison of twin A to twin B; Comparison of Twin A to Twin B
twin B; Sampling of the facial and fecal microbiome	Other: comparison of twin A to twin B; Comparison of Twin A to Twin B

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Characterization of the facial and fecal microbiome of monozygotic or dizygotic twins with facial rosacea	Characterization of the facial and fecal microbiome in monozygotic or dizygotic twins concordant or discordant for rosacea compared to a) each other, b) microbiome library of age-matched controls	Single sampling of facial microbiome done on site over a 2-day Festival August 5 and 6, 2017.

Collaborators and Investigators

• Sponsor: The Acne Cure Alliance

Study record dates

Study Major Dates

• Study Start (Anticipated): August 5, 2017
• Primary Completion (Anticipated): August 6, 2017
• Study Completion (Anticipated): August 6, 2017

Study Registration Dates

• First Submitted: July 18, 2017
• First Submitted That Met QC Criteria: July 22, 2017
• First Posted (Actual): July 25, 2017

Study Record Updates

• Last Update Posted (Actual): July 26, 2017
• Last Update Submitted That Met QC Criteria: July 24, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Rosacea
• Other Study ID Numbers: 713

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: There is no plan to share any IPD with other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No