Acne VulgarisPhase 1NCT03709654
A Study of the Safety, Engraftment, and Action of Multi-Dosed NB01 in Adults With Moderate Acne
A Phase 1 study testing NB01 in people with Acne Vulgaris, run by Naked Biome, Inc. at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- NB01
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Nov 2018to 30 Sep 2019
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 11Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
01
Arlington, Texas, 76011
02
Austin, Texas, 78759
03
San Diego, California, 92123
About this study
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
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.
Read the detailed description
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 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 (NB01) to restore the skin to a healthy state via this replacement therapy.
The investigators aim to test this in a Phase 1B multiple application study evaluating the safety, tolerability, and clinical impact that a multiple, daily, applications of NB01 has on adult subjects with moderate acne. Investigators will be profiling the change in microbiome over the course of therapy to determine if exogenously delivered bacteria can populate the skin (engraftment) and cause a shift in the microbiome safely and subsequently impact acne biomarkers that may correlate with clinical disease.
The investigators intend for this therapy to eventually be used in acne subjects with ages ranging from 13-40, and all disease severities as either monotherapy for mild to mild/moderate acne and as an adjuvant therapy for moderate to severe acne at all body sites, with special attention to facial involvement.
This approach is standard to acne therapy whereby mild disease will be treated with a monotherapy (i.e., topical Benzoyl peroxide [BPO]) and moderate/severe disease will be treated with various combinatory regimens (topical antibiotics, BPO, topical retinoids, oral antibiotics).
Primary Objectives:
- To determine the safety and tolerability of a multiple application of topical P. acnes microbiome transplant ("NB01").
Exploratory Objectives:
- To define engraftment duration of NB01.
- To evaluate preliminary clinical efficacy using Acne Lesion Counts (total, inflammatory, and non-inflammatory), Investigator Global Assessment (IGA), and subjective improvement of acne based on subject reported outcomes (Acne QoL Questionnaire).
- To evaluate treatment effects, based on sebum production in a subpopulation from sites 02 and 03.
Approximately 36 total male and female adult subjects combined with moderate, non-cyclical acne will be enrolled into the trial. Approximately twenty four (24) subjects will be randomly assigned treatment and twelve (12) subjects will be randomly assigned to vehicle control.
This is a multiple topical application study of live bacteria for the study of acne in adult subjects. Following a 5-7 day pretreatment of gold standard benzoyl peroxide therapy to kill resident facial bacterial, 11 weeks of daily topical application of NB01 will be evaluated.
Subject participation in the trial will approximately 12 weeks.
- Conditions
- Acne Vulgaris
- Being tested
- NB01, Vehicle Control
- Keywords
- acne, pimple, black head, white head, zit, probiotic
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NB01Biological
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
Vehicle ControlOther
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
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Subjects will undergo 1 week lead-in with BPO followed by 11 weeks of NB01 probiotic applied topically. Receives: Biological: NB01 |
| Vehicle Control | Placebo comparator | Subjects will undergo 1 week lead-in with BPO followed by 11 weeks of vehicle applied topically. Receives: Other: Vehicle Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Changes in Local Skin Reactions
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.
Measured: Day 0 through day 80
Number of Participants With Successful Follicular Engraftment of NB01
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.
Measured: 12 weeks
Absolute Change in Genotype Markers: Skin Surface Engraftment "Success"
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.
Measured: Day 0 through day 80
Absolute Change From Screening in Acne Lesion Counts
Reporting absolute change in counts.
Measured: Day 0 through day 80
Percent Change From Screening in Acne Lesion Counts
Efficacy endpoint: Percent change from Screening lesion counts at Day 80 (end of treatment)
Measured: Day 0 through day 80
Number of Participants Achieving "Success" on Investigator Global Assessment (IGA)
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.
Measured: Day 0 through day 80
Change in Acne QoL Questionnaire Score
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.
Measured: Day 0 through day 80
Absolute Change From Screening in Acne Lesion Counts: Outlier Censored
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.
Measured: Day 0 through day 80
Percent Change From Screening in Acne Lesion Counts: Outlier Censored
Efficacy endpoint: Percent change from Screening lesion counts at Day 80 (end of treatment)
Measured: Day 0 through day 80
Follicular Engraftment
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.
Measured: 12 weeks
Secondary outcomes (1)
Absolute Change in Sebum Production.
Exploratory Endpoint: Absolute change from Baseline to week 12 in sebum production measured at the mid-glabellar region of the forehead using a Sebumeter.
Measured: Day 0 through day 80
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2018
- Study start1 Nov 2018
- Primary completion30 Sep 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Double Blind Vehicle Controlled Trial, dual arm with 2:1 treatment to vehicle assignment
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Naked Biome, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Therapeutics, Inc.
- Responsible party
- Sponsor
- Investigators
- Emma Taylor, MD, Study director, Naked Biome
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03709654
- Sponsor's protocol ID
- NB01-P1BMA
- Status last verified
- Jul 2020
- First submitted
- 9 Oct 2018
- Last updated
- 3 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Initially there is no plan to share IPD. This may change later as the clinical plan develops.
Publications
Fitz-Gibbon S, Tomida S, Chiu BH, Nguyen L, Du C, Liu M, Elashoff D, Erfe MC, Loncaric A, Kim J, Modlin RL, Miller JF, Sodergren E, Craft N, Weinstock GM, Li H. Propionibacterium acnes strain populations in the human skin microbiome associated with acne. J Invest Dermatol. 2013 Sep;133(9):2152-60. doi: 10.1038/jid.2013.21. Epub 2013 Jan 21.
PubMed 23337890Johnson T, Kang D, Barnard E, Li H. Strain-Level Differences in Porphyrin Production and Regulation in Propionibacterium acnes Elucidate Disease Associations. mSphere. 2016 Feb 10;1(1):e00023-15. doi: 10.1128/mSphere.00023-15. eCollection 2016 Jan-Feb.
PubMed 27303708McDowell A, Barnard E, Nagy I, Gao A, Tomida S, Li H, Eady A, Cove J, Nord CE, Patrick S. An expanded multilocus sequence typing scheme for propionibacterium acnes: investigation of 'pathogenic', 'commensal' and antibiotic resistant strains. PLoS One. 2012;7(7):e41480. doi: 10.1371/journal.pone.0041480. Epub 2012 Jul 30.
PubMed 22859988Tomida S, Nguyen L, Chiu BH, Liu J, Sodergren E, Weinstock GM, Li H. Pan-genome and comparative genome analyses of propionibacterium acnes reveal its genomic diversity in the healthy and diseased human skin microbiome. mBio. 2013 Apr 30;4(3):e00003-13. doi: 10.1128/mBio.00003-13.
PubMed 23631911
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03709654
- Acronym / sponsor ID
- NB01-P1BMA
- Conditions
- Acne Vulgaris
- Keywords
- acne, pimple, black head, white head, zit, probiotic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Naked Biome, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Therapeutics, Inc.
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 17 Oct 2018 (actual)
- Results
- Posted 3 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 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 (NB01) to restore the skin to a healthy state via this replacement therapy.
The investigators aim to test this in a Phase 1B multiple application study evaluating the safety, tolerability, and clinical impact that a multiple, daily, applications of NB01 has on adult subjects with moderate acne. Investigators will be profiling the change in microbiome over the course of therapy to determine if exogenously delivered bacteria can populate the skin (engraftment) and cause a shift in the microbiome safely and subsequently impact acne biomarkers that may correlate with clinical disease.
The investigators intend for this therapy to eventually be used in acne subjects with ages ranging from 13-40, and all disease severities as either monotherapy for mild to mild/moderate acne and as an adjuvant therapy for moderate to severe acne at all body sites, with special attention to facial involvement.
This approach is standard to acne therapy whereby mild disease will be treated with a monotherapy (i.e., topical Benzoyl peroxide [BPO]) and moderate/severe disease will be treated with various combinatory regimens (topical antibiotics, BPO, topical retinoids, oral antibiotics).
Primary Objectives:
- To determine the safety and tolerability of a multiple application of topical P. acnes microbiome transplant ("NB01").
Exploratory Objectives:
- To define engraftment duration of NB01.
- To evaluate preliminary clinical efficacy using Acne Lesion Counts (total, inflammatory, and non-inflammatory), Investigator Global Assessment (IGA), and subjective improvement of acne based on subject reported outcomes (Acne QoL Questionnaire).
- To evaluate treatment effects, based on sebum production in a subpopulation from sites 02 and 03.
Approximately 36 total male and female adult subjects combined with moderate, non-cyclical acne will be enrolled into the trial. Approximately twenty four (24) subjects will be randomly assigned treatment and twelve (12) subjects will be randomly assigned to vehicle control.
This is a multiple topical application study of live bacteria for the study of acne in adult subjects. Following a 5-7 day pretreatment of gold standard benzoyl peroxide therapy to kill resident facial bacterial, 11 weeks of daily topical application of NB01 will be evaluated.
Subject participation in the trial will approximately 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized Double Blind Vehicle Controlled Trial, dual arm with 2:1 treatment to vehicle assignment
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Biological: NB01Subjects will undergo 1 week lead-in with BPO followed by 11 weeks of NB01 probiotic applied topically. |
| Vehicle Control | Placebo comparator | Other: Vehicle ControlSubjects will undergo 1 week lead-in with BPO followed by 11 weeks of vehicle applied topically. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NB015-7 day pretreatment of gold standard benzoyl peroxide therapy to kill resident facial bacterial followed by 11 weeks of daily topical application of NB01 | Biological | Treatment Arm |
| Vehicle Control5-7 day pretreatment of gold standard benzoyl peroxide therapy to kill resident facial bacterial followed by 11 weeks of daily topical application of vehicle control | Other | Vehicle Control |
Primary outcome
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.
1 secondary outcome
Absolute Change in Sebum Production.
Time frame: Day 0 through day 80
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23337890Fitz-Gibbon S, Tomida S, Chiu BH, Nguyen L, Du C, Liu M, Elashoff D, Erfe MC, Loncaric A, Kim J, Modlin RL, Miller JF, Sodergren E, Craft N, Weinstock GM, Li H. Propionibacterium acnes strain populations in the human skin microbiome associated with acne. J Invest Dermatol. 2013 Sep;133(9):2152-60. doi: 10.1038/jid.2013.21. Epub 2013 Jan 21.
- Results publication: PubMed 27303708Johnson T, Kang D, Barnard E, Li H. Strain-Level Differences in Porphyrin Production and Regulation in Propionibacterium acnes Elucidate Disease Associations. mSphere. 2016 Feb 10;1(1):e00023-15. doi: 10.1128/mSphere.00023-15. eCollection 2016 Jan-Feb.
- Results publication: PubMed 22859988McDowell A, Barnard E, Nagy I, Gao A, Tomida S, Li H, Eady A, Cove J, Nord CE, Patrick S. An expanded multilocus sequence typing scheme for propionibacterium acnes: investigation of 'pathogenic', 'commensal' and antibiotic resistant strains. PLoS One. 2012;7(7):e41480. doi: 10.1371/journal.pone.0041480. Epub 2012 Jul 30.
- Results publication: PubMed 23631911Tomida S, Nguyen L, Chiu BH, Liu J, Sodergren E, Weinstock GM, Li H. Pan-genome and comparative genome analyses of propionibacterium acnes reveal its genomic diversity in the healthy and diseased human skin microbiome. mBio. 2013 Apr 30;4(3):e00003-13. doi: 10.1128/mBio.00003-13.
- DermNet New Zealand. Acne vulgaris: Acne GradingLink provided by the sponsor.
- \[FDA\] Guidance for Industry: Acne Vulgaris: Developing Drugs for Treatment. Draft: September 2005Link provided by the sponsor.
- Early Clinical Trials with Live Biotherapeutic FDA Guidance for Industry: Products: Chemistry, Manufacturing, and Control InformationLink provided by the sponsor.
- FDA Guidance for Industry CGMP for Phase 1 Investigational DrugsLink provided by the sponsor.
- Individual participant dataSharing planned: No. Initially there is no plan to share IPD. This may change later as the clinical plan develops.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emma Taylor, MD study director
Naked Biome
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NB01 in people with Acne Vulgaris, run by Naked Biome, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Changes in Local Skin Reactions (time frame: Day 0 through day 80). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03709654, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2020.