Back to resultsStudy to Determine Safety and Efficacy of B244 in Subjects With Mild to Moderate Atopic Dermatitis
Primary Purpose
Atopic Dermatitis Eczema
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
B244
Vehicle
Sponsored by
About this trial
This is an interventional treatment trial for Atopic Dermatitis Eczema
Eligibility Criteria
Inclusion Criteria:
- Male and female subjects ≥18 years of age
- In good general health as determined by a thorough medical history and physical examination, and vital signs
- Clinical diagnosis of mild to moderate atopic dermatitis according to the criteria of Hanifin and Rajka
- Mild to moderate Atopic Dermatitis area and severity index [EASI] 10-21
- A score of at least ≥ 5 points (moderate pruritus) on the VAS for pruritus
- A minimum of 10% and not more than 30% of the subjects' BSA affected by atopic dermatitis (affected is defined by physical examination findings: erythema, edema, scaling, lichenification, excoriation, with the excoriation serving as the physical examination correlate of pruritus)
- An IGA score of 2-3
- Patient has a history of AD for ≥12 months
- Ability to read and understand English and to provide written informed consent and authorization for protected health information disclosure
Exclusion Criteria:
- Pregnant and lactating women by urine pregnancy testing
- Subjects with any significant clinical abnormalities which may interfere with study participation
- Any skin condition which may interfere with evaluation of AD
- Atopic dermatitis only on the head or scalp
- Subjects with Atopic dermatitis on the face
- Unstable or actively infected atopic dermatitis
- Patients suffering from pruritus from conditions other than AD
- Patients with chronic pruritus due to systemic disease
- Patients with conditions requiring inhaled steroids
- Have concurrent skin disease of such severity in the study area that it could interfere with the study evaluation
- Have active skin infections on the treatment area
- Have received or planning to receive topical corticosteroids, topical coal tar, topical sulfur, topical PDE-4 inhibitors, topical antihistamines, topical antiseptics or antibiotics, topical antifungals, bleach baths, UVA or UVB phototherapy, oral/IV/inhaled steroids, antibiotics/antiviral/antifungal agents, oral probiotics, glucocorticoids treatment, calcineurin inhibitors, immunomodulating biologic agents, systemic glucocorticoids, systemic immunosuppressive or immunomodulatory agents within 2 weeks of Baseline visit.
- Current or recent history (≤3 months of systemic use of Otrexup™, Rasuvo®, Rheumatrex® and Trexall™ or its generic versions such as Methotrexate
- History of being seropositive for human immunodeficiency virus (HIV) at screening by laboratory testing at Screening
- History of being positive for Hepatitis B virus surface antigen (HBsAg) or positive Hepatitis C virus antibody (HCV Ab) at screening by laboratory testing at Screening
- History of renal disease
- Use of any investigational drugs within the previous 30 days prior to dosing or within a period of less than five times the drug's half-life, whichever is longer
- Use of any biologic within a period of 5 times its half-life
- Use of vinegar or bleach baths within 2 weeks of starting the study
Sites / Locations
- Central Research Associates
- Elite Clinical Studies
- Encino Research Center
- Orange County Research Center
- Neostart Corporation d.b.a AGA Clinical Trials
- Clinical Neuroscience Solution, Inc
- FXM Research Corp.
- FXM Research Miramar
- Clinical Neuroscience Solution, Inc
- Clinical Research Trials of Florida, Inc.
- Columbus Regional Research Institute
- DeNova Research dba Arano, LLC
- Clarkston Skin Research
- MediSearch Clinical Trials
- LoveLace Scientific Resources
- Central Sooner Research
- Paddington Testing Co.
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
B244
Vehicle
Arm Description
B244 suspension in 30ml/bottle Subjects will apply a total of 8 pumps of IP per application to all affected areas twice-a-day.
Vehicle, 30ml/bottle Subjects will apply a total of 8 pumps of IP per application to all affected areas twice-a-day.
Outcomes
Primary Outcome Measures
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
Safety and tolerability endpoints will consist of all adverse events reporting during the study duration.
Secondary Outcome Measures
Change in Eczema Area Severity Index (EASI) Score Between the Active and Vehicle Groups
EASI is a validated tool used to measure the severity and extent of atopic dermatitis where clinical investigators assess the presence and severity of erythema, edema/papulation, excoriation, and lichenification (score 0-3: none=0, mild=1, moderate=2, severe=3, half-points allowed) and area of involvement (score 0-6: 0=0% involvement, 1=1-9% involvement, 2=10-29% involvement, 3=30-49% involvement, 4=50-69% involvement, 5=70-89% involvement, 6=90-100% involvement) across head and neck, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks). The EASI score can range from 0.0to 72.0 with increments of 0.1 and higher scores representing a greater severity of atopic dermatitis.
Full Information
NCT ID
NCT03235024
First Posted
July 20, 2017
Last Updated
October 6, 2022
Sponsor
AOBiome LLC
Collaborators
Veristat, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03235024
Brief Title
Study to Determine Safety and Efficacy of B244 in Subjects With Mild to Moderate Atopic Dermatitis
Official Title
A Prospective, Vehicle Controlled, Double Blind, Multicenter, Randomized, Phase II Study of B244 Delivered as a Topical Spray to Determine Safety and Efficacy in Subjects With Mild to Moderate Atopic Dermatitis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
January 15, 2018 (Actual)
Primary Completion Date
February 27, 2019 (Actual)
Study Completion Date
March 20, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AOBiome LLC
Collaborators
Veristat, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a Prospective, Vehicle Controlled, Double Blind, Multicenter, Randomized Phase II trial, comparing the effect of twice daily B244 application for 28 days vs vehicle application on treatment of mild to moderate AD
Detailed Description
This is a Prospective, Vehicle Controlled, Double Blind, Multicenter, Randomized Phase II trial, comparing the effect of twice daily B244 application for 28 days vs vehicle application on treatment of mild to moderate AD
At Screening and Baseline, all subjects must have atopic dermatitis, as defined by the Hanifin and Rajka criteria, which involves a minimum of 10% and a maximum of 30% body surface area, EASI score of 10 to 21 and pruritus visual analogue scale scores of ≥ 5 points on the VAS scale (at least moderate).
The total duration of the study will be approximately 9 weeks. Participants will report for a Screening visit and if all inclusion criteria are met, subjects will go through a two week washout phase before reporting for a Baseline visit.
Subjects will come in for visits at Day 14 (Week 2), Day 28 (Week 4). A final visit will be conducted at Day 42 (Week 6).
Efficacy will be assessed using Atopic Dermatitis Area and Severity Index (EASI) and Visual Analog Scale (VAS).
Blood and urine samples will be collected for standard safety laboratory tests and effect of the drug on inflammatory biomarkers. Participant's safety will be monitored throughout the study.
Investigators plan to enroll approximately 130 total patients.
Randomization will be 1:1 so that equal number of patients will be treated in each Arm of the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis Eczema
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Randomization will be 1:1 so that equal number of patients will be treated in each Arm of the study.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
This is a double blind study. Participants will be assigned to study treatment in accordance with the randomization schedule generated for the allocation of vehicle or B244 prior to the initiation of the trial. Randomization will be centrally-based and performed using an appropriate IWRS (an automated randomization system).
Each participant scheduled to receive investigational product (IP) will receive a randomization number at the time of randomization. The randomization number will be used to identify the study medication kit assigned to the participant and indicate the treatment to be administered to that participant.
Allocation
Randomized
Enrollment
122 (Actual)
8. Arms, Groups, and Interventions
Arm Title
B244
Arm Type
Active Comparator
Arm Description
B244 suspension in 30ml/bottle
Subjects will apply a total of 8 pumps of IP per application to all affected areas twice-a-day.
Arm Title
Vehicle
Arm Type
Placebo Comparator
Arm Description
Vehicle, 30ml/bottle
Subjects will apply a total of 8 pumps of IP per application to all affected areas twice-a-day.
Intervention Type
Biological
Intervention Name(s)
B244
Intervention Description
B244 suspension
Intervention Type
Biological
Intervention Name(s)
Vehicle
Intervention Description
Vehicle suspension
Primary Outcome Measure Information:
Title
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
Description
Safety and tolerability endpoints will consist of all adverse events reporting during the study duration.
Time Frame
Baseline to Day 42
Secondary Outcome Measure Information:
Title
Change in Eczema Area Severity Index (EASI) Score Between the Active and Vehicle Groups
Description
EASI is a validated tool used to measure the severity and extent of atopic dermatitis where clinical investigators assess the presence and severity of erythema, edema/papulation, excoriation, and lichenification (score 0-3: none=0, mild=1, moderate=2, severe=3, half-points allowed) and area of involvement (score 0-6: 0=0% involvement, 1=1-9% involvement, 2=10-29% involvement, 3=30-49% involvement, 4=50-69% involvement, 5=70-89% involvement, 6=90-100% involvement) across head and neck, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks). The EASI score can range from 0.0to 72.0 with increments of 0.1 and higher scores representing a greater severity of atopic dermatitis.
Time Frame
Baseline to Day 28
Other Pre-specified Outcome Measures:
Title
Change in Visual Analog Scale (VAS) Score for Pruritus Between the Active and Vehicle Group
Description
VAS (Visual Analog Scale) was performed as a measure of pruritus. The VAS is composed of a 10-cm line divided into a scale from 0 to 10, and subjects were to indicate the score that best represented the intensity of their itching over the 24-hour period before each visit where a higher score indicated greater severity in pruritus.
Time Frame
Baseline to Day 28
Title
Change in the Skindex 16 Score Between the Active and Vehicle Group
Description
The Skindex 16 questionnaire was assigned to subjects to examine the relationship between the subject's skin health and quality of life. Subjects scored 16 questions from 0 to 6 (0=never bothered, 6=always bothered). Total scores could range between 0 to 96, where a higher score is associated with a worse quality of life.
Time Frame
Baseline to Day 28
Title
Change in the IGA Score Between the Active and Vehicle Groups
Description
IGA (Investigator's Global Assessment) was used to assess the overall diseases severity on a scale of 0 to 4 (0=clear, 1=almost clear, 2=mild disease, 3=moderate disease, and 4=severe disease).
Time Frame
Baseline to Day 28
Title
Difference in Actigraphy Scratching Event Count Per Hour During the Night Between the Active and Vehicle Group
Description
Subjects were provided two Actigraphy watches (one on each wrist) to accurately monitor subject's sleep, activity, and itching patterns.
Time Frame
Baseline to Day 28
Title
Difference in Biomarkers Between Active and Vehicle Groups.
Description
To evaluate if B244 administration on the skin twice daily for 28 days will affect the levels of immune biomarkers.
Time Frame
Baseline and Day 28
Title
Microbial Content
Description
Evaluate if B244 administration on skin twice daily will affect the microbial content on collected skin swab samples.
Time Frame
Baseline and Day 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male and female subjects ≥18 years of age
In good general health as determined by a thorough medical history and physical examination, and vital signs
Clinical diagnosis of mild to moderate atopic dermatitis according to the criteria of Hanifin and Rajka
Mild to moderate Atopic Dermatitis area and severity index [EASI] 10-21
A score of at least ≥ 5 points (moderate pruritus) on the VAS for pruritus
A minimum of 10% and not more than 30% of the subjects' BSA affected by atopic dermatitis (affected is defined by physical examination findings: erythema, edema, scaling, lichenification, excoriation, with the excoriation serving as the physical examination correlate of pruritus)
An IGA score of 2-3
Patient has a history of AD for ≥12 months
Ability to read and understand English and to provide written informed consent and authorization for protected health information disclosure
Exclusion Criteria:
Pregnant and lactating women by urine pregnancy testing
Subjects with any significant clinical abnormalities which may interfere with study participation
Any skin condition which may interfere with evaluation of AD
Atopic dermatitis only on the head or scalp
Subjects with Atopic dermatitis on the face
Unstable or actively infected atopic dermatitis
Patients suffering from pruritus from conditions other than AD
Patients with chronic pruritus due to systemic disease
Patients with conditions requiring inhaled steroids
Have concurrent skin disease of such severity in the study area that it could interfere with the study evaluation
Have active skin infections on the treatment area
Have received or planning to receive topical corticosteroids, topical coal tar, topical sulfur, topical PDE-4 inhibitors, topical antihistamines, topical antiseptics or antibiotics, topical antifungals, bleach baths, UVA or UVB phototherapy, oral/IV/inhaled steroids, antibiotics/antiviral/antifungal agents, oral probiotics, glucocorticoids treatment, calcineurin inhibitors, immunomodulating biologic agents, systemic glucocorticoids, systemic immunosuppressive or immunomodulatory agents within 2 weeks of Baseline visit.
Current or recent history (≤3 months of systemic use of Otrexup™, Rasuvo®, Rheumatrex® and Trexall™ or its generic versions such as Methotrexate
History of being seropositive for human immunodeficiency virus (HIV) at screening by laboratory testing at Screening
History of being positive for Hepatitis B virus surface antigen (HBsAg) or positive Hepatitis C virus antibody (HCV Ab) at screening by laboratory testing at Screening
History of renal disease
Use of any investigational drugs within the previous 30 days prior to dosing or within a period of less than five times the drug's half-life, whichever is longer
Use of any biologic within a period of 5 times its half-life
Use of vinegar or bleach baths within 2 weeks of starting the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Judith Ng-Cashin, MD
Organizational Affiliation
Chief Medical Officer
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Spiros Jamas, ScD
Organizational Affiliation
AOBiome LLC
Official's Role
Study Director
Facility Information:
Facility Name
Central Research Associates
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Elite Clinical Studies
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Facility Name
Encino Research Center
City
Encino
State/Province
California
ZIP/Postal Code
91436
Country
United States
Facility Name
Orange County Research Center
City
Tustin
State/Province
California
ZIP/Postal Code
92780
Country
United States
Facility Name
Neostart Corporation d.b.a AGA Clinical Trials
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Clinical Neuroscience Solution, Inc
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
FXM Research Corp.
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Facility Name
FXM Research Miramar
City
Miramar
State/Province
Florida
ZIP/Postal Code
33027
Country
United States
Facility Name
Clinical Neuroscience Solution, Inc
City
Orlando
State/Province
Florida
ZIP/Postal Code
32801
Country
United States
Facility Name
Clinical Research Trials of Florida, Inc.
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
Columbus Regional Research Institute
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
DeNova Research dba Arano, LLC
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Clarkston Skin Research
City
Clarkston
State/Province
Michigan
ZIP/Postal Code
48349
Country
United States
Facility Name
MediSearch Clinical Trials
City
Saint Joseph
State/Province
Missouri
ZIP/Postal Code
64506
Country
United States
Facility Name
LoveLace Scientific Resources
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87108
Country
United States
Facility Name
Central Sooner Research
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73071
Country
United States
Facility Name
Paddington Testing Co.
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19103
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study to Determine Safety and Efficacy of B244 in Subjects With Mild to Moderate Atopic Dermatitis
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