ClinicalTrials.gg
WithdrawnNCT04214483Updated Jun 5, 2025

A Pilot Study to Explore the Role of Gut Flora in Acne

An observational study in Acne, Acne Vulgaris and Acne Keloidalis, sponsored by ProgenaBiome. Withdrawn at 1 site in United States. Per ClinicalTrials.gov, last updated 2025-06-05.

Sponsored by ProgenaBiome · Observational

Why this study was withdrawn
Company shifted focus
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
0
Sex
All
01

Study summary

This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records.

Read the detailed description

The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to acne.

02

Conditions studied

  • Acne
  • Acne Vulgaris
  • Acne Keloidalis
  • Acne Keloid
  • Acne Conglobata
  • Acne Rosacea
  • Acne Inversa
  • Acne Cystic
  • Acne Pomade
  • Acne Indurata
  • Acne Papular
  • Acne Tropica
  • Acne Urticata
  • Acne Fulminans
  • Acne Follicular
  • Acne Tropicalis
  • Acne Detergicans
  • Acne Iodide
  • Acne Varioliformis
03

In context

Acne Vulgaris

790 studies on the registry are indexed under Acne Vulgaris; 93 are open to participants now.

Browse Acne Vulgaris studies →

Lead sponsor

ProgenaBiome is the lead sponsor of 47 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with acne

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Signed , demonstrating that the patient understands the procedures required for the study and the purpose of the study

    a. May be signed by parent or legal guardian in the case of minor or adult unable to provide consent

  2. Male or female of all ages.
  3. Diagnosis of acne by a physician

Exclusion criteria

Exclusion Criteria:

  1. Refusal to sign form
  2. History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy.
  3. Postoperative stoma, ostomy, or ileoanal pouch
  4. Participation in any experimental drug protocol within the past 12 weeks
  5. Treatment with total parenteral nutrition
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
0 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Diagnosis of Acne

    Patients who have been diagnosed with acne, subdivided into the various types.

    Other: No intervention

Interventions

  • OtherNo intervention

    There is no intervention for this study.

06

What researchers measure

Primary outcomes

  1. Correlation of Microbiome to Disease via Relative Abundance Found in Microbiome Sequencing

    Relative abundance of bacterial classes within taxonomic phyla and, more broadly, within their domain will be analyzed by sequencing the gut microbiome. These data will then be categorized with acne.

    Time frame: Three years

07

Study locations

1 site
  • ProgenaBiome
    Ventura, California 93003, United States
08

References and documents

Individual participant data

Plan to share: No — There is no plan to share IPD

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Mar 2020 (actual). Primary completion is estimated for Mar 2030, 120 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 27, 2019
First posted
Jan 2, 2020
StartActual
Mar 2, 2020
Primary completionEst.
Mar 2030
CompletionEst.
Jul 2030
Last update
Jun 5, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 5, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04214483
Lead sponsor
ProgenaBiome
Responsible party
Sponsor
First posted
Jan 2, 2020
Start date
Mar 2, 2020
Primary completion
Mar 2030 (estimated)
Completion
Jul 2030 (estimated)
Last update
Jun 5, 2025

Study contacts

Sabine Hazan, MD
principal investigator · ProgenaBiome

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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