Phase 1
N=36
A Study of the Safety, Engraftment, and Action of Multi-Dosed NB01 in Adults With Moderate Acne
Acne Vulgaris
Bottom Line
View on ClinicalTrials.gov: NCT03709654 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Aug 2020
Primary outcome: Primary: Number of Participants With Changes in Local Skin Reactions — 19; 11; 2; 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- NB01 (Biological); Vehicle Control (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Naked Biome, Inc.
- Primary completion
- Sep 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Changes in Local Skin Reactions |
19; 11; 2; 1; 19; 9 | — |
| PRIMARY Number of Participants With Successful Follicular Engraftment of NB01 |
1; 0 | — |
| PRIMARY Absolute Change in Genotype Markers: Skin Surface Engraftment "Success" |
6.9; 2.5; 5.5; 2.9; 3.9; 14.9 | — |
| PRIMARY Absolute Change From Screening in Acne Lesion Counts |
-4.3; -4.7; -8.4; -6.7; -15.5; -14.5 | — |
| PRIMARY Percent Change From Screening in Acne Lesion Counts |
-15.8; -14.8; -28.9; -20.0; -54.8; -49.2 | — |
| PRIMARY Number of Participants Achieving "Success" on Investigator Global Assessment (IGA) |
0; 0; 1; 0; 6; 1 | — |
| PRIMARY Change in Acne QoL Questionnaire Score |
9.7; 33.2 | — |
| PRIMARY Absolute Change From Screening in Acne Lesion Counts: Outlier Censored |
-4.2; -4.7; -8.5; -6.7; -15.1; -14.5 | — |
| PRIMARY Percent Change From Screening in Acne Lesion Counts: Outlier Censored |
-15.2; -14.8; -29.0; -20.0; -53.0; -49.2 | — |
| PRIMARY Follicular Engraftment |
6518.9; 492 | — |
| SECONDARY Absolute Change in Sebum Production. |
26.2; -22.9 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Subject has provided written informed consent.
- Subject is male or non-pregnant female, 18-40 years of age, inclusive at Screening.
- Subject has moderate facial acne vulgaris
- Female subject with non-cyclical acne.
- Women of childbearing potential (WOCBP) willing to use adequate contraception during study participation
- Male subjects willing to use an acceptable method of contraception during study participation.
- Subject has the ability to personally apply benzoyl peroxide (BPO) and study drug, as per protocol.
Exclusion Criteria
- Subject has active bacterial, viral, or fungal skin infections.
- Subject has active nodulocystic acne or acne conglobate, acne fulminans, or other forms of acne (e.g., acne mechanica).
- Subject is currently participating in an investigational drug, device, or biologic study or has used an investigational drug, biologic or device treatment within 30 days prior to first application of the study drug.
- Subjects with prosthetic heart valves, pacemakers, intravascular catheters, or other foreign or prosthetic devices/implantable devices/hardware.
- Subject has a history of chronic human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV) infections.
- Subject has a history of malignancy (with the exception of non-melanoma skin cancer).
- Subject is immunosuppressed (such as resulting from transplantation, immunosuppressive therapy, active HIV infection/acquired immune deficiency syndrome [AIDS], neutropenia).
- Subject had a major surgical procedure, open biopsy, or significant traumatic injury within 14 days of initiating study drug (unless the wound has healed), or anticipation of the need for major surgery during the study.
- Subjects with close contacts (e.g., spouses, children, or members in the same household) that have severe skin barrier defects or are immunocompromised.
- Female subject is pregnant or lactating or is planning to become pregnant and/or breast feed within the duration of study participation.
Other entry criteria not listed above will be reviewed of each prospective subject by the study staff to confirm eligibility
Data sourced from ClinicalTrials.gov (NCT03709654). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.