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NCT03709654 · ClinicalTrials.gov registry record · Phase 1
A Study of the Safety, Engraftment, and Action of Multi-Dosed NB01 in Adults With Moderate Acne
A Phase 1 study, sponsored by Naked Biome.
- Completed
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
NCT03709654: Completed Phase 1 study, sponsored by Naked Biome.
NCT03709654 is a Phase 1 study that has completed, run by Naked Biome. The registered enrollment target is 36 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03709654, a Phase 1 study, has completed, sponsored by Naked Biome.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
Study Summary
Acne vulgaris is a disease caused my multiple factors including overgrowth of bacteria, clogged pores, excessive sebum production and hormonal changes. Recent literature from the Human Microbiome Project has shown there are bacterial strains specific to healthy and acne disease states (Fitz-Gibbon et al, 2013, Johnson et al, 2016, McDowell et al, 2012, Tomida et al, 2013) From this data, the investigators hypothesize that by eliminating disease-associated bacterial strains and replacing them with health-associated strains, recurrences or flares of acne may be improved, mitigated, and prevented. Instead of current approaches which focus on eliminating all bacteria from the skin, the investigators aim to deliver healthy bacteria to restore the skin to a healthy state via this replacement therapy. The investigators aim to test this in a Phase Ib multiple application study evaluating the safety, tolerability, and clinical impact that a multiple applications of NB01 have on adult subjects with moderate acne.
Primary Outcome
Local Skin Reactions (LSRs) including Erythema, edema, erosion/ulceration, scaling/dryness, and scabbing/crusting scored at Baseline (day of first application) and Week 12 (end of treatment) and reported for each visit as: Absent, Mild, Moderate, or Severe. The number of participants (and %) with no change or improvement from Baseline to week 12 visit are reported. The number of participants (and %) whose score worsened from Baseline to week 12 visit are reported.
Interventions
- OTHER Vehicle Control
- BIOLOGICAL NB01
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2018-11-01 |
| Est. Completion | 2019-09-30 |
| Phase | Phase 1 |
What the finished NCT03709654 record still lists
NCT03709654 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower).
The record links to 0 conditions, and to 2 interventions - of which Vehicle Control is the first listed.
NCT03709654 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03709654 about?
NCT03709654 is a clinical study titled "A Study of the Safety, Engraftment, and Action of Multi-Dosed NB01 in Adults With Moderate Acne". Acne vulgaris is a disease caused my multiple factors including overgrowth of bacteria, clogged pores, excessive sebum production and hormonal changes. Recent literature from the Human Microbiome Project has shown there are bacterial strains specific to healthy and acne disease states (Fitz-Gibbon e...
What is the current status of trial NCT03709654?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2018-11-01. Estimated completion is 2019-09-30.
What interventions are being tested in trial NCT03709654?
The interventions under investigation include: Vehicle Control (OTHER), NB01 (BIOLOGICAL).
Who is sponsoring clinical trial NCT03709654?
This trial is sponsored by Naked Biome, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03709654's enrollment target sits among peer trials
36 1210th of 2000 higher than 743 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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