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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 Withdrawn at 1 site in United States.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Why this study was withdrawn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

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

Inclusion criteria

  1. Signed informed consent, 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 informed consent 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
04

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.

05

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

06

Study locations

1 site
  • ProgenaBiome
    Ventura, California 93003, United States
07

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.

08

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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