Ignite Creation Date:
2026-03-26 @ 3:21 PM
Ignite Modification Date:
2026-03-29 @ 11:28 PM
Study NCT ID:
NCT03228927
Status:
UNKNOWN
Last Update Posted:
2017-07-26
First Post:
2017-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Characterization of the Facial and Gut Microbiome in Rosacea
Sponsor:
The Acne Cure Alliance
Organization:
Study Overview
Official Title:
Characterization of the Facial and Gut Microbiome in Identical and Fraternal Twins With Rosacea; Comparison to Healthy Controls
Status:
UNKNOWN
Status Verified Date:
2017-07
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: