A Study of the Safety, Engraftment, and Action of Multi-Dosed NB01 in Adults With Moderate Acne
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|ClinicalTrials.gov Identifier: NCT03709654|
Recruitment Status : Completed
First Posted : October 17, 2018
Results First Posted : August 3, 2020
Last Update Posted : August 3, 2020
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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.
|Condition or disease||Intervention/treatment||Phase|
|Acne Vulgaris||Biological: NB01 Other: Vehicle Control||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized Double Blind Vehicle Controlled Trial, dual arm with 2:1 treatment to vehicle assignment|
|Masking:||Double (Participant, Investigator)|
|Masking Description:||Double blind|
|Official Title:||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|
|Actual Study Start Date :||November 1, 2018|
|Actual Primary Completion Date :||September 30, 2019|
|Actual Study Completion Date :||September 30, 2019|
Experimental: Treatment Arm
Subjects will undergo 1 week lead-in with BPO followed by 11 weeks of NB01 probiotic applied topically.
5-7 day pretreatment of gold standard benzoyl peroxide therapy to kill resident facial bacterial followed by 11 weeks of daily topical application of NB01
Placebo Comparator: Vehicle Control
Subjects will undergo 1 week lead-in with BPO followed by 11 weeks of vehicle applied topically.
Other: Vehicle Control
5-7 day pretreatment of gold standard benzoyl peroxide therapy to kill resident facial bacterial followed by 11 weeks of daily topical application of vehicle control
- Number of Participants With Changes in Local Skin Reactions [ Time Frame: Day 0 through day 80 ]
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.
- Number of Participants With Successful Follicular Engraftment of NB01 [ Time Frame: 12 weeks ]
Follicular engraftment sampling used Biore® Strips at Screening and day 80 (several days after end of treatment).
The number of subjects with "success" at EOT where "success" is defined as a Follicular Biore® sample with "yes" outcome based on recovery of live NB01at day 80.
- Absolute Change in Genotype Markers: Skin Surface Engraftment "Success" [ Time Frame: Day 0 through day 80 ]Skin surface engraftment "success" endpoint is deﬁned by a change in genotype (TaqMan) markers compared to Screening; value is percentage of bacterial population containing health-associated genotype. Result is absolute change from screening value.
- Absolute Change From Screening in Acne Lesion Counts [ Time Frame: Day 0 through day 80 ]Reporting absolute change in counts.
- Percent Change From Screening in Acne Lesion Counts [ Time Frame: Day 0 through day 80 ]Efficacy endpoint: Percent change from Screening lesion counts at Day 80 (end of treatment)
- Number of Participants Achieving "Success" on Investigator Global Assessment (IGA) [ Time Frame: Day 0 through day 80 ]
The investigator assessed the participant's inflammatory lesions on the face using the Investigator Global Assessment (IGA) 5-point scale.
The scale ranges from 0 (best): clear, no evidence of papules or pustules to 4 (worst): severe, inflammatory lesions are more apparent, many papules/pustules.
The outcome is the number of subjects in each treatment group achieving "success" at Week 12; "success" defined as an IGA score of "clear (score=0)" or "almost clear (score=1)" and at least a two-point reduction in IGA compared to Baseline.
- Change in Acne QoL Questionnaire Score [ Time Frame: Day 0 through day 80 ]
At each visit, subjects were asked to complete the Acne Quality of Life [QoL] Questionnaire to assess subjective improvement of acne with 7 response choices ranging from extremely to not at all. The total score ranges from 19 to 114; higher scores reflect improved QoL.
Outcome measure is absolute change in Acne QoL (Total Score) from Baseline to Day 80.
- Absolute Change From Screening in Acne Lesion Counts: Outlier Censored [ Time Frame: Day 0 through day 80 ]
After reviewing the data, one Treatment Arm subject was found to be an extreme outlier and was censored from this ad-hoc analysis.
Reporting absolute change in counts.
- Percent Change From Screening in Acne Lesion Counts: Outlier Censored [ Time Frame: Day 0 through day 80 ]Efficacy endpoint: Percent change from Screening lesion counts at Day 80 (end of treatment)
- Follicular Engraftment [ Time Frame: 12 weeks ]Follicular communities were genotyped for health-associated loci at both Screening and 12-week visits. The percent increase of Cas5 in multiple communities from each subject is reported.
- Absolute Change in Sebum Production. [ Time Frame: Day 0 through day 80 ]Exploratory Endpoint: Absolute change from Baseline to week 12 in sebum production measured at the mid-glabellar region of the forehead using a Sebumeter.
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|Ages Eligible for Study:||18 Years to 40 Years (Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03709654
|United States, California|
|San Diego, California, United States, 92123|
|United States, Texas|
|Arlington, Texas, United States, 76011|
|Austin, Texas, United States, 78759|
|Study Director:||Emma Taylor, MD||Naked Biome|
Documents provided by Naked Biome, Inc.:
Publications of Results:
|Responsible Party:||Naked Biome, Inc.|
|Other Study ID Numbers:||
|First Posted:||October 17, 2018 Key Record Dates|
|Results First Posted:||August 3, 2020|
|Last Update Posted:||August 3, 2020|
|Last Verified:||July 2020|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Plan Description:||Initially there is no plan to share IPD. This may change later as the clinical plan develops.|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
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