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NCT03450369 · ClinicalTrials.gov registry record · Phase 1
A Study of the Safety, Engraftment, and Action of NB01 in Adults With Moderate Acne
A Phase 1 study of Acne Vulgaris, sponsored by Naked Biome.
- Completed
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT03450369: Completed Phase 1 study of Acne Vulgaris, sponsored by Naked Biome.
NCT03450369 is a Phase 1 study of Acne Vulgaris that has completed, run by Naked Biome. The registered enrollment target is 10 participants, below the 275-participant average among 67 other Acne Vulgaris trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03450369, a Phase 1 study of Acne Vulgaris, has completed, sponsored by Naked Biome.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study Summary
Acne vulgaris is a multifactorial disease caused by overgrowth of Propionibacterium acnes (P. acnes), impaction of hair follicles, excessive sebum production and hormonal dysregulation. Recent literature from the Human Microbiome Project has shown there are unique microbial signatures specific to healthy and acne disease states. From this data, the investigators hypothesize that by eliminating resident disease-associated bacterial strains and replacing them with health-associated strains, recurrences/fares 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 single application study evaluating the safety, tolerability, and clinical impact that a single application of NB01, a live strain of P. acnes, has on adult subjects with moderate acne.
Primary Outcome
Engraftment is defined as the percentage of bacteria recovered from hair follicles that are health-associated (NB01) as measured with proprietary quantitative polymerase chain assays. Successful follicular engraftment, defined as both deoR/PanBac \>40% and Cas5/PanBac \>40% in the Day 2 (24H) ) Biore Strip samples. Cas5/PanBac and deoR/PanBac are the percentages of bacteria in a sample containing the CRISPR associated protein Cas5 and a repressor of porphyrin production deoR, respectively. Pan-B
Conditions Studied
Interventions
- BIOLOGICAL NB01
Study Locations (1)
California
- Dermatology Research Associates - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2018-01-24 |
| Est. Completion | 2018-06-18 |
| Phase | Phase 1 |
What the finished NCT03450369 record still lists
NCT03450369 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 275-participant average among 67 other Acne Vulgaris trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Acne Vulgaris appearing as the primary indexed condition, and to 1 intervention - of which NB01 is the first listed.
NCT03450369 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT03450369 about?
NCT03450369 is a clinical study titled "A Study of the Safety, Engraftment, and Action of NB01 in Adults With Moderate Acne". Acne vulgaris is a multifactorial disease caused by overgrowth of Propionibacterium acnes (P. acnes), impaction of hair follicles, excessive sebum production and hormonal dysregulation. Recent literature from the Human Microbiome Project has shown there are unique microbial signatures specific to he...
What is the current status of trial NCT03450369?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2018-01-24. Estimated completion is 2018-06-18.
What conditions does trial NCT03450369 study?
This clinical trial studies the following conditions: Acne Vulgaris.
What interventions are being tested in trial NCT03450369?
The interventions under investigation include: NB01 (BIOLOGICAL).
Who is sponsoring clinical trial NCT03450369?
This trial is sponsored by Naked Biome, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03450369 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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