Characterization of the Facial and Gut Microbiome in Rosacea

Rosacea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03228927
• Other study ID #: 713
• Status: Not yet recruiting
• Phase: N/A
• First received: July 18, 2017
• Last updated: July 24, 2017
• Start date: August 5, 2017
• Est. completion date: August 6, 2017

Study information

• Verified date: July 2017
• Source: The Acne Cure Alliance
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: August 6, 2017
• Est. primary completion date: August 6, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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 -

Related Conditions & MeSH terms

• Rosacea

Intervention

Other:
• comparison of twin A to twin B
Comparison of Twin A to Twin B

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Acne Cure Alliance

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.