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
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Atopic Dermatitis Eczema
- Sponsor
- AOBiome LLC
- Enrollment
- 122
- Locations
- 16
- Primary Endpoint
- Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
Time Frame: Baseline to Day 42
Safety and tolerability endpoints will consist of all adverse events reporting during the study duration.
Secondary Outcomes
- Change in Eczema Area Severity Index (EASI) Score Between the Active and Vehicle Groups(Baseline to Day 28)