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 : Recruiting
First Posted : October 17, 2018
Last Update Posted : January 3, 2019
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)|
|Estimated Enrollment :||60 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|
|Estimated Primary Completion Date :||May 30, 2019|
|Estimated Study Completion Date :||August 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
- Adverse Events (AEs) [ Time Frame: Day 0 through day 80 ]AEs will be assessed by the investigator and the incidence (severity and causality) of any local and systemic AEs will be reported.
- 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 by frequency and severity at every visit.
- Follicular Engraftment "Success" [ Time Frame: Day 0 through day 80 ]
Follicular engraftment sampling will be completed via use of Biore® Strips at baseline and day 80 (end of treatment).
Engraftment "Success" Endpoint: The proportion 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
- Skin surface engraftment "Success" [ Time Frame: Day 0 through day 80 ]
Skin surface engraftment sampling will be completed via cheek swab at each visit.
Skin surface engraftment "success" endpoint is defined by a percent change in TaqMan markers compared to Baseline
- Absolute change from baseline in Acne Lesion Counts (total, inflammatory, and non-inflammatory) [ Time Frame: Day 0 through day 80 ]Efficacy endpoint: Absolute change from Baseline lesion counts at Day 80 (end of treatment)
- Percent change from baseline in Acne Lesion Counts (total, inflammatory, and non-inflammatory). [ Time Frame: Day 0 through day 80 ]Efficacy endpoint: Percent change from Baseline lesion counts at Day 80 (end of treatment)
- Investigator Global Assessment (IGA) [ Time Frame: Day 0 through day 80 ]Proportion of subjects in each treatment group achieving "success" at Week 12, with "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.
- Acne QoL Questionnaire [ Time Frame: Day 0 through day 80 ]
At each visit, subjects will be asked to complete the Acne QoL Questionnaire to assess subjective improvement of acne with 7 response choices ranging from extremely to not at all.
Efficacy Endpoint: Absolute change from Baseline in Acne QoL to Day 80 end of treatment visit.
- Absolute change in sebum production. [ Time Frame: Day 0 through day 80 ]Exploratory Endpoint: Absolute and percent change from Baseline in sebum production
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
|Contact: Emma Taylor, MDfirstname.lastname@example.org|
|Contact: TI Clinical Research||858-571-1800 ext email@example.com|
|United States, California|
|San Diego, California, United States, 92123|
|Contact: Neil Bhatia, MD 858-571-6800 firstname.lastname@example.org|
|Principal Investigator: Bhatia, MD|
|United States, Texas|
|Arlington, Texas, United States, 76011|
|Contact 817-795-7546 email@example.com|
|Principal Investigator: Moore, MD|
|Austin, Texas, United States, 78759|
|Contact 512-349-9889 firstname.lastname@example.org|
|Principal Investigator: DuBois, MD|
|Study Director:||Emma Taylor, MD||Naked Biome|