Trial Outcomes & Findings for Clinical Trial in Subjects With Mild to Moderate Acne Vulgaris (NCT NCT02832063)

NCT ID: NCT02832063

Last Updated: 2022-09-16

Results Overview

Safety and tolerability endpoints will consist of all treatment related adverse events reporting during the study duration.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

372 participants

Primary outcome timeframe

16 weeks

Results posted on

2022-09-16

Participant Flow

Participant milestones

Participant milestones
Measure	B244 Arm B244 dose (4x10E9 cells/mL) administered in a 1:1 (active vs placebo) ratio B244: 4 pumps of spray to saturate the entire face applied BID. Applications should occur in the morning and at night for 12 weeks.	Placebo Arm Placebo dose administered in a 1:1 (active vs placebo) ratio Placebo: 4 pumps of spray to saturate the entire face applied BID. Applications should occur in the morning and at night for 12 weeks.
Overall Study STARTED	186	186
Overall Study COMPLETED	152	148
Overall Study NOT COMPLETED	34	38

Reasons for withdrawal

Reasons for withdrawal
Measure	B244 Arm B244 dose (4x10E9 cells/mL) administered in a 1:1 (active vs placebo) ratio B244: 4 pumps of spray to saturate the entire face applied BID. Applications should occur in the morning and at night for 12 weeks.	Placebo Arm Placebo dose administered in a 1:1 (active vs placebo) ratio Placebo: 4 pumps of spray to saturate the entire face applied BID. Applications should occur in the morning and at night for 12 weeks.
Overall Study Adverse Event	2	1
Overall Study Physician Decision	5	7
Overall Study Lost to Follow-up	15	8
Overall Study Withdrawal by Subject	10	21
Overall Study Other	2	1

Baseline Characteristics

Clinical Trial in Subjects With Mild to Moderate Acne Vulgaris

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	B244 Arm n=181 Participants B244 dose (4x10E9 cells/mL) administered in a 1:1 (active vs placebo) ratio B244: 4 pumps of spray to saturate the entire face applied BID. Applications should occur in the morning and at night for 12 weeks.	Placebo Arm n=179 Participants Placebo dose administered in a 1:1 (active vs placebo) ratio Placebo: 4 pumps of spray to saturate the entire face applied BID. Applications should occur in the morning and at night for 12 weeks.	Total n=360 Participants Total of all reporting groups
Age, Customized 18 to <30 years	126 Participants n=5 Participants	122 Participants n=7 Participants	248 Participants n=5 Participants
Age, Customized 30 to <65 years	55 Participants n=5 Participants	57 Participants n=7 Participants	112 Participants n=5 Participants
Sex: Female, Male Female	95 Participants n=5 Participants	92 Participants n=7 Participants	187 Participants n=5 Participants
Sex: Female, Male Male	86 Participants n=5 Participants	87 Participants n=7 Participants	173 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	39 Participants n=5 Participants	37 Participants n=7 Participants	76 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	137 Participants n=5 Participants	141 Participants n=7 Participants	278 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	27 Participants n=5 Participants	21 Participants n=7 Participants	48 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	19 Participants n=5 Participants	9 Participants n=7 Participants	28 Participants n=5 Participants
Race (NIH/OMB) White	107 Participants n=5 Participants	133 Participants n=7 Participants	240 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	28 Participants n=5 Participants	16 Participants n=7 Participants	44 Participants n=5 Participants

PRIMARY outcome

Timeframe: 16 weeks

Population: Efficacy analysis set: all subjects who received at least 1 application of IP

Safety and tolerability endpoints will consist of all treatment related adverse events reporting during the study duration.

Outcome measures

Outcome measures
Measure	B244 Arm n=181 Participants B244 dose (4x10E9 cells/mL) administered in a 1:1 (active vs placebo) ratio B244: 4 pumps of spray to saturate the entire face applied BID. Applications should occur in the morning and at night for 12 weeks.	Placebo Arm n=179 Participants Placebo dose administered in a 1:1 (active vs placebo) ratio Placebo: 4 pumps of spray to saturate the entire face applied BID. Applications should occur in the morning and at night for 12 weeks.
Number of Participants With Treatment RelatedAdverse Events At Least 1 Treatment Related TEAE	10 Participants	9 Participants
Number of Participants With Treatment RelatedAdverse Events At Least 1 Treatment Related SAE	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: Efficacy analysis set: all subjects who received at least 1 application of IP

Lesion counting was performed using the digital photos taken by participants and stored inside the study mobile platform by trained personnel only. Every effort was made to have the counting and clinical evaluation done by the same evaluator for a given participant. Lesions under the jaw line or behind the hairline (including eyebrows) were not included in the counts. Papules, pustules, cysts and nodules were classified as inflammatory acne lesions, and open and closed comedones were classified as non-inflammatory lesions.

Outcome measures

Outcome measures
Measure	B244 Arm n=181 Participants B244 dose (4x10E9 cells/mL) administered in a 1:1 (active vs placebo) ratio B244: 4 pumps of spray to saturate the entire face applied BID. Applications should occur in the morning and at night for 12 weeks.	Placebo Arm n=179 Participants Placebo dose administered in a 1:1 (active vs placebo) ratio Placebo: 4 pumps of spray to saturate the entire face applied BID. Applications should occur in the morning and at night for 12 weeks.
Change in Inflammatory and Non-inflammatory Lesion Count Change in Inflammatory Lesion Count from Baseline to Week 12	-4.8 lesions Standard Deviation 10.1	-3.9 lesions Standard Deviation 9.13
Change in Inflammatory and Non-inflammatory Lesion Count Change in Non-Inflammatory Lesion Count from Baseline to Week 12	-4.0 lesions Standard Deviation 22.0	-4.9 lesions Standard Deviation 20.9

PRIMARY outcome

Timeframe: 12 weeks

Population: Efficacy analysis set: all subjects who received at least 1 application of IP

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). IGA success was defined as a post-baseline score of 0 or 1 (yes=success, no=no success).

Outcome measures

Outcome measures
Measure	B244 Arm n=181 Participants B244 dose (4x10E9 cells/mL) administered in a 1:1 (active vs placebo) ratio B244: 4 pumps of spray to saturate the entire face applied BID. Applications should occur in the morning and at night for 12 weeks.	Placebo Arm n=179 Participants Placebo dose administered in a 1:1 (active vs placebo) ratio Placebo: 4 pumps of spray to saturate the entire face applied BID. Applications should occur in the morning and at night for 12 weeks.
Number of Participants Demonstrating Efficacy Measured by Investigator Global Assessment Success Yes	25 Participants	12 Participants
Number of Participants Demonstrating Efficacy Measured by Investigator Global Assessment Success No	127 Participants	137 Participants

SECONDARY outcome

Timeframe: Baseline to weeks 2, 4, 8, 12 and 16

Population: Efficacy analysis set: all subjects who received at least 1 application of IP

Outcome measures

Outcome measures
Measure	B244 Arm n=181 Participants B244 dose (4x10E9 cells/mL) administered in a 1:1 (active vs placebo) ratio B244: 4 pumps of spray to saturate the entire face applied BID. Applications should occur in the morning and at night for 12 weeks.	Placebo Arm n=179 Participants Placebo dose administered in a 1:1 (active vs placebo) ratio Placebo: 4 pumps of spray to saturate the entire face applied BID. Applications should occur in the morning and at night for 12 weeks.
Change in Inflammatory and Non-inflammatory Lesion Count by Week Change in Inflammatory Lesion Count from Baseline to Week 2	-1.5 lesions Standard Deviation 10.9	-1.3 lesions Standard Deviation 9.94
Change in Inflammatory and Non-inflammatory Lesion Count by Week Change in Inflammatory Lesion Count from Baseline to Week 4	-0.8 lesions Standard Deviation 10.46	-0.8 lesions Standard Deviation 9.49
Change in Inflammatory and Non-inflammatory Lesion Count by Week Change in Inflammatory Lesion Count from Baseline to Week 8	-3.3 lesions Standard Deviation 9.94	-3.1 lesions Standard Deviation 8.75
Change in Inflammatory and Non-inflammatory Lesion Count by Week Change in Inflammatory Lesion Count from Baseline to Week 12	-4.8 lesions Standard Deviation 10.1	-3.9 lesions Standard Deviation 9.13
Change in Inflammatory and Non-inflammatory Lesion Count by Week Change in Inflammatory Lesion Count from Baseline to Week 16	-3.2 lesions Standard Deviation 20.6	-4.0 lesions Standard Deviation 11.4
Change in Inflammatory and Non-inflammatory Lesion Count by Week Change in Non-Inflammatory Lesion Count from Baseline to Week 2	-0.9 lesions Standard Deviation 17.1	-2.1 lesions Standard Deviation 18.4
Change in Inflammatory and Non-inflammatory Lesion Count by Week Change in Non-Inflammatory Lesion Count from Baseline to Week 4	-1.5 lesions Standard Deviation 21.3	-4.6 lesions Standard Deviation 19.1
Change in Inflammatory and Non-inflammatory Lesion Count by Week Change in Non-Inflammatory Lesion Count from Baseline to Week 8	-4.1 lesions Standard Deviation 20.4	-5.8 lesions Standard Deviation 17.4
Change in Inflammatory and Non-inflammatory Lesion Count by Week Change in Non-Inflammatory Lesion Count from Baseline to Week 12	-4.0 lesions Standard Deviation 22.0	-4.9 lesions Standard Deviation 20.9
Change in Inflammatory and Non-inflammatory Lesion Count by Week Change in Non-Inflammatory Lesion Count from Baseline to Week 16	-6.4 lesions Standard Deviation 23.2	-6.1 lesions Standard Deviation 21.7

SECONDARY outcome

Timeframe: Baseline to weeks 2, 4, 8, 12 and 16

Population: Subjects from the efficacy analysis set (all subjects who received at least 1 application of IP) that remained in the study up to each respective time point for the outcome measure.

Outcome measures

Outcome measures
Measure	B244 Arm n=181 Participants B244 dose (4x10E9 cells/mL) administered in a 1:1 (active vs placebo) ratio B244: 4 pumps of spray to saturate the entire face applied BID. Applications should occur in the morning and at night for 12 weeks.	Placebo Arm n=179 Participants Placebo dose administered in a 1:1 (active vs placebo) ratio Placebo: 4 pumps of spray to saturate the entire face applied BID. Applications should occur in the morning and at night for 12 weeks.
Number of Participants Demonstrating Efficacy Measured Investigator Global Assessment Score by Week Week 16 · Yes	12 Participants	17 Participants
Number of Participants Demonstrating Efficacy Measured Investigator Global Assessment Score by Week Week 2 · Yes	12 Participants	13 Participants
Number of Participants Demonstrating Efficacy Measured Investigator Global Assessment Score by Week Week 2 · No	162 Participants	157 Participants
Number of Participants Demonstrating Efficacy Measured Investigator Global Assessment Score by Week Week 4 · Yes	9 Participants	13 Participants
Number of Participants Demonstrating Efficacy Measured Investigator Global Assessment Score by Week Week 4 · No	159 Participants	153 Participants
Number of Participants Demonstrating Efficacy Measured Investigator Global Assessment Score by Week Week 8 · Yes	16 Participants	10 Participants
Number of Participants Demonstrating Efficacy Measured Investigator Global Assessment Score by Week Week 8 · No	144 Participants	150 Participants
Number of Participants Demonstrating Efficacy Measured Investigator Global Assessment Score by Week Week 12 · Yes	25 Participants	12 Participants
Number of Participants Demonstrating Efficacy Measured Investigator Global Assessment Score by Week Week 12 · No	127 Participants	137 Participants
Number of Participants Demonstrating Efficacy Measured Investigator Global Assessment Score by Week Week 16 · No	140 Participants	131 Participants

SECONDARY outcome

Timeframe: Baseline to weeks 2, 4, 8, 12 and 16

Population: Efficacy analysis set: all subjects who received at least 1 application of IP

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.

Outcome measures

Outcome measures
Measure	B244 Arm n=181 Participants B244 dose (4x10E9 cells/mL) administered in a 1:1 (active vs placebo) ratio B244: 4 pumps of spray to saturate the entire face applied BID. Applications should occur in the morning and at night for 12 weeks.	Placebo Arm n=179 Participants Placebo dose administered in a 1:1 (active vs placebo) ratio Placebo: 4 pumps of spray to saturate the entire face applied BID. Applications should occur in the morning and at night for 12 weeks.
Change in Patient Reported Quality of Life Score Using the Skindex-16 Questionnaire Change from Baseline to Week 2	-0.6 score on a scale Standard Deviation 1.05	-1.6 score on a scale Standard Deviation 0.97
Change in Patient Reported Quality of Life Score Using the Skindex-16 Questionnaire Change from Baseline to Week 4	-0.7 score on a scale Standard Deviation 1.10	-0.7 score on a scale Standard Deviation 1.12
Change in Patient Reported Quality of Life Score Using the Skindex-16 Questionnaire Change from Baseline to Week 8	-0.6 score on a scale Standard Deviation 1.23	-0.7 score on a scale Standard Deviation 1.16
Change in Patient Reported Quality of Life Score Using the Skindex-16 Questionnaire Change from Baseline to Week 12	-0.7 score on a scale Standard Deviation 1.16	-0.6 score on a scale Standard Deviation 1.17
Change in Patient Reported Quality of Life Score Using the Skindex-16 Questionnaire Change from Baseline to Week 16	-0.8 score on a scale Standard Deviation 1.16	-0.7 score on a scale Standard Deviation 1.17

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline, week 4, week 8, week 12, and week 16

Population: Data was not collected for this exploratory endpoint.

Evaluate if B244 administration on skin twice daily will affect the microbial content on collected skin swab samples.

Outcome measures

Outcome data not reported

Adverse Events

B244 Arm

Serious events: 3 serious events

Other events: 39 other events

Deaths: 0 deaths

Placebo Arm

Serious events: 2 serious events

Other events: 42 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	B244 Arm n=181 participants at risk B244 dose (4x10E9 cells/mL) administered in a 1:1 (active vs placebo) ratio B244: 4 pumps of spray to saturate the entire face applied BID. Applications should occur in the morning and at night for 12 weeks.	Placebo Arm n=179 participants at risk Placebo dose administered in a 1:1 (active vs placebo) ratio Placebo: 4 pumps of spray to saturate the entire face applied BID. Applications should occur in the morning and at night for 12 weeks.
General disorders Pyrexia	0.00% 0/181 • Baseline to Week 16. Participants will report adverse events immediately to the Investigator and study personnel. Participants will also be solicited for adverse events at each scheduled visit. Limited vital signs may be measured at home intermittently and recorded in the study mobile application by the participants.	0.56% 1/179 • Baseline to Week 16. Participants will report adverse events immediately to the Investigator and study personnel. Participants will also be solicited for adverse events at each scheduled visit. Limited vital signs may be measured at home intermittently and recorded in the study mobile application by the participants.
Psychiatric disorders Depression	0.55% 1/181 • Baseline to Week 16. Participants will report adverse events immediately to the Investigator and study personnel. Participants will also be solicited for adverse events at each scheduled visit. Limited vital signs may be measured at home intermittently and recorded in the study mobile application by the participants.	0.00% 0/179 • Baseline to Week 16. Participants will report adverse events immediately to the Investigator and study personnel. Participants will also be solicited for adverse events at each scheduled visit. Limited vital signs may be measured at home intermittently and recorded in the study mobile application by the participants.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.55% 1/181 • Baseline to Week 16. Participants will report adverse events immediately to the Investigator and study personnel. Participants will also be solicited for adverse events at each scheduled visit. Limited vital signs may be measured at home intermittently and recorded in the study mobile application by the participants.	0.00% 0/179 • Baseline to Week 16. Participants will report adverse events immediately to the Investigator and study personnel. Participants will also be solicited for adverse events at each scheduled visit. Limited vital signs may be measured at home intermittently and recorded in the study mobile application by the participants.
Gastrointestinal disorders Gastroenteritis	0.00% 0/181 • Baseline to Week 16. Participants will report adverse events immediately to the Investigator and study personnel. Participants will also be solicited for adverse events at each scheduled visit. Limited vital signs may be measured at home intermittently and recorded in the study mobile application by the participants.	0.56% 1/179 • Baseline to Week 16. Participants will report adverse events immediately to the Investigator and study personnel. Participants will also be solicited for adverse events at each scheduled visit. Limited vital signs may be measured at home intermittently and recorded in the study mobile application by the participants.
Renal and urinary disorders Nephrolithiasis	0.55% 1/181 • Baseline to Week 16. Participants will report adverse events immediately to the Investigator and study personnel. Participants will also be solicited for adverse events at each scheduled visit. Limited vital signs may be measured at home intermittently and recorded in the study mobile application by the participants.	0.56% 1/179 • Baseline to Week 16. Participants will report adverse events immediately to the Investigator and study personnel. Participants will also be solicited for adverse events at each scheduled visit. Limited vital signs may be measured at home intermittently and recorded in the study mobile application by the participants.

Other adverse events

Additional Information

Hyun Kim, Vice President Clinical Operations

AOBiome Therapeutics

Phone: 617-639-9980

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee PI may not publish or otherwise publicly disclose the analyzed study data and conclusions drawn from the study without the written consent of Sponsor.
Publication restrictions are in place

Restriction type: OTHER