A Study of the Safety, Engraftment, and Action of Multi-Dosed NB01 in Adults With Moderate Acne
| Status: | Recruiting |
|---|---|
| Conditions: | Acne, Acne, Dermatology |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | 18 - 40 |
| Updated: | 1/5/2019 |
| Start Date: | November 1, 2018 |
| End Date: | August 30, 2019 |
| Contact: | Emma Taylor, MD |
| Email: | emma.t@nakedbiome.com |
| Phone: | 858-571-1800 |
A Multicenter, Randomized, Double-Blind, Vehicle-Controlled Phase 1B Study of the Safety, Short-Term Engraftment and Action of 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 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.
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.
Inclusion Criteria:
1. Subject has provided written informed consent.
2. Subject is male or non-pregnant female, 18-40 years of age, inclusive at Screening.
3. Subject has moderate facial acne vulgaris
4. Female subject with non-cyclical acne.
5. Women of childbearing potential (WOCBP) willing to use adequate contraception during
study participation
6. Male subjects willing to use an acceptable method of contraception during study
participation.
7. Subject has the ability to personally apply benzoyl peroxide (BPO) and study drug, as
per protocol.
Exclusion Criteria:
1. Subject has active bacterial, viral, or fungal skin infections.
2. Subject has active nodulocystic acne or acne conglobate, acne fulminans, or other
forms of acne (e.g., acne mechanica).
3. 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.
4. Subjects with prosthetic heart valves, pacemakers, intravascular catheters, or other
foreign or prosthetic devices/implantable devices/hardware.
5. Subject has a history of chronic human immunodeficiency virus (HIV), hepatitis C virus
(HCV), or hepatitis B virus (HBV) infections.
6. Subject has a history of malignancy (with the exception of non-melanoma skin cancer).
7. Subject is immunosuppressed (such as resulting from transplantation, immunosuppressive
therapy, active HIV infection/acquired immune deficiency syndrome [AIDS],
neutropenia).
8. 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.
9. Subjects with close contacts (e.g., spouses, children, or members in the same
household) that have severe skin barrier defects or are immunocompromised.
10. 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
We found this trial at
3
sites
Austin, Texas 78744
Principal Investigator: DuBois, MD
Phone: 512-349-9889
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Arlington, Texas 76017
Principal Investigator: Moore, MD
Phone: 817-795-7546
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San Diego, California
Principal Investigator: Bhatia, MD
Phone: 858-571-6800
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