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Characterization of the Facial and Gut Microbiome in Rosacea

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ClinicalTrials.gov Identifier: NCT03228927
Recruitment Status : Unknown
Verified July 2017 by Hilary Baldwin, The Acne Cure Alliance.
Recruitment status was:  Not yet recruiting
First Posted : July 25, 2017
Last Update Posted : July 26, 2017
Sponsor:
Information provided by (Responsible Party):
Hilary Baldwin, The Acne Cure Alliance

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.

Condition or disease Intervention/treatment
Rosacea 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.

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Characterization of the Facial and Gut Microbiome in Identical and Fraternal Twins With Rosacea; Comparison to Healthy Controls
Estimated Study Start Date : August 5, 2017
Estimated Primary Completion Date : August 6, 2017
Estimated Study Completion Date : August 6, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rosacea

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




Primary Outcome Measures :
  1. Characterization of the facial and fecal microbiome of monozygotic or dizygotic twins with facial rosacea [ Time Frame: Single sampling of facial microbiome done on site over a 2-day Festival August 5 and 6, 2017. ]
    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


Biospecimen Retention:   Samples Without DNA
skin swab and fecal sample


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Attendees at the Twins Days Festival Monozygotic or dizygotic twin sets Facial Rosacea
Criteria

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 -

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Responsible Party: Hilary Baldwin, Medical Director, The Acne Cure Alliance
ClinicalTrials.gov Identifier: NCT03228927     History of Changes
Other Study ID Numbers: 713
First Posted: July 25, 2017    Key Record Dates
Last Update Posted: July 26, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share any IPD with other researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Rosacea
Skin Diseases