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A Study of the Safety, Engraftment, and Action of NB01 in Adults With Moderate Acne

NCT03450369 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2020-08-03

Study results available
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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.

Conditions

  • Acne Vulgaris

Interventions

BIOLOGICAL

NB01

Use an existing therapy designed to kill existing facial bacterial followed by populating facial skin with a single application of NB01

Sponsors & Collaborators

  • Dermatology Research Institute

    collaborator OTHER

  • QST Consultations, Ltd.

    collaborator INDUSTRY

  • Science 37

    collaborator INDUSTRY

  • Naked Biome, Inc.

    lead INDUSTRY

Principal Investigators

  • Emma Taylor, MD · CEO

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-24
Primary Completion
2018-06-18
Completion
2018-06-18
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03450369 on ClinicalTrials.gov