Trial Outcomes & Findings for A Double Blind, Placebo-Controlled, Randomized Study in Subjects With Acne Vulgaris (NCT NCT02656485)

Last Updated: 2017-04-05

Results Overview

Number of participants with treatment related adverse events as assessed by physical examination, vital signs, clinical laboratory values, local skin responses

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

36 participants

Primary outcome timeframe

4 weeks

Results posted on

2017-04-05

Participant Flow

Participant milestones

Participant milestones
Measure	Dose I BB244 Dose I : 10 pumps of spray applied BID twice a day to the entire face for 14 days	Dose II BB244 Dose II : 10 pumps of spray applied BID twice a day to the entire face for 14 days	Dose III BB244 Dose III: 10 pumps of spray applied BID twice a day to the entire face for 14 days	Placebo Placebo: 10 pumps of spray applied BID twice a day to the entire face for 14 days
Overall Study STARTED	9	9	9	9
Overall Study COMPLETED	7	6	7	7
Overall Study NOT COMPLETED	2	3	2	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Double Blind, Placebo-Controlled, Randomized Study in Subjects With Acne Vulgaris

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dose I n=9 Participants B244 dose strength I B244: 10 pumps (1.4 ml) of spray must be applied BID twice a day to the entire face for 14 days	Dose II n=9 Participants B244 dose strength II B244: 10 pumps (1.4 ml) of spray must be applied BID twice a day to the entire face for 14 days	Dose III n=9 Participants B244 dose strength III B244: 10 pumps (1.4 ml) of spray must be applied BID twice a day to the entire face for 14 days	Placebo n=9 Participants Placebo Placebo: 10 pumps (1.4 ml) of spray must be applied BID twice a day to the entire face for 14 days	Total n=36 Participants Total of all reporting groups
Age, Continuous	29.4 years STANDARD_DEVIATION 10.0 • n=93 Participants	26 years STANDARD_DEVIATION 8.2 • n=4 Participants	29.2 years STANDARD_DEVIATION 4.8 • n=27 Participants	31.7 years STANDARD_DEVIATION 10.1 • n=483 Participants	29.1 years STANDARD_DEVIATION 8.4 • n=36 Participants
Sex: Female, Male Female	7 Participants n=93 Participants	5 Participants n=4 Participants	7 Participants n=27 Participants	9 Participants n=483 Participants	28 Participants n=36 Participants
Sex: Female, Male Male	2 Participants n=93 Participants	4 Participants n=4 Participants	2 Participants n=27 Participants	0 Participants n=483 Participants	8 Participants n=36 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	1 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	1 Participants n=36 Participants
Race (NIH/OMB) Asian	1 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	1 Participants n=483 Participants	2 Participants n=36 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Race (NIH/OMB) Black or African American	1 Participants n=93 Participants	1 Participants n=4 Participants	3 Participants n=27 Participants	2 Participants n=483 Participants	7 Participants n=36 Participants
Race (NIH/OMB) White	3 Participants n=93 Participants	2 Participants n=4 Participants	5 Participants n=27 Participants	4 Participants n=483 Participants	14 Participants n=36 Participants
Race (NIH/OMB) More than one race	1 Participants n=93 Participants	2 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	3 Participants n=36 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=93 Participants	3 Participants n=4 Participants	1 Participants n=27 Participants	2 Participants n=483 Participants	9 Participants n=36 Participants

PRIMARY outcome

Timeframe: 4 weeks

Population: The safety analysis set included all subjects in the ITT/Safety population.

Number of participants with treatment related adverse events as assessed by physical examination, vital signs, clinical laboratory values, local skin responses

Outcome measures

Outcome measures
Measure	Dose I n=9 Participants B244 dose I B244: 10 pumps (1.4 ml) of spray must be applied BID twice a day to the entire face for 14 days	Dose II n=9 Participants B244 dose II B244: 10 pumps (1.4 ml) of spray must be applied BID twice a day to the entire face for 14 days	Dose III n=9 Participants B244 dose III B244: 10 pumps (1.4 ml) of spray must be applied BID twice a day to the entire face for 14 days	Placebo n=9 Participants Placebo Placebo: 10 pumps (1.4 ml) of spray must be applied BID twice a day to the entire face for 14 days
Safety (Number of Participants With Treatment Related Adverse Events)	4 Participants	1 Participants	2 Participants	2 Participants

SECONDARY outcome

Timeframe: Baseline and 4 weeks

Population: All efficacy and safety data were analyzed using the ITT/Safety population.

Absolute Change from Baseline in Total Number of Lesions

Outcome measures

Outcome measures
Measure	Dose I n=26 Participants B244 dose I B244: 10 pumps (1.4 ml) of spray must be applied BID twice a day to the entire face for 14 days	Dose II n=8 Participants B244 dose II B244: 10 pumps (1.4 ml) of spray must be applied BID twice a day to the entire face for 14 days	Dose III B244 dose III B244: 10 pumps (1.4 ml) of spray must be applied BID twice a day to the entire face for 14 days	Placebo Placebo Placebo: 10 pumps (1.4 ml) of spray must be applied BID twice a day to the entire face for 14 days
Efficacy	-9.6 Lesions Standard Deviation 12.09	-6.7 Lesions Standard Deviation 10.66	—	—

Adverse Events

Dose I

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Dose II

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Dose III

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Masha Gaber

AOBIOME

Phone: 617-475-1605

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Dose I n=9 participants at risk B244 Dose 1 (dose level \[cells/mL\] 20,000,000,000) B244: 10 pumps (1.4 ml) of spray must be applied BID twice a day to the entire face for 14 days	Dose II n=9 participants at risk B244 Dose 2 (dose level \[cells/mL\] 40,000,000,000) B244: 10 pumps (1.4 ml) of spray must be applied BID twice a day to the entire face for 14 days	Dose III n=9 participants at risk B244 Dose 3 (dose level \[cells/mL\] 80,000,000,000) B244: 10 pumps (1.4 ml) of spray must be applied BID twice a day to the entire face for 14 days	Placebo n=9 participants at risk Placebo Placebo: 10 pumps (1.4 ml) of spray must be applied BID twice a day to the entire face for 14 days
Infections and infestations Nasopharyngitis	11.1% 1/9 • Subjects were monitored for Adverse Events from Study Day 1 through Day 28 of the study During each visit, the Investigator questioned the subject about adverse events using an open question taking care not to influence the subject's answers, e.g., "have you noticed any change in your health?"	0.00% 0/9 • Subjects were monitored for Adverse Events from Study Day 1 through Day 28 of the study During each visit, the Investigator questioned the subject about adverse events using an open question taking care not to influence the subject's answers, e.g., "have you noticed any change in your health?"	0.00% 0/9 • Subjects were monitored for Adverse Events from Study Day 1 through Day 28 of the study During each visit, the Investigator questioned the subject about adverse events using an open question taking care not to influence the subject's answers, e.g., "have you noticed any change in your health?"	0.00% 0/9 • Subjects were monitored for Adverse Events from Study Day 1 through Day 28 of the study During each visit, the Investigator questioned the subject about adverse events using an open question taking care not to influence the subject's answers, e.g., "have you noticed any change in your health?"
General disorders Application Site Pain	11.1% 1/9 • Subjects were monitored for Adverse Events from Study Day 1 through Day 28 of the study During each visit, the Investigator questioned the subject about adverse events using an open question taking care not to influence the subject's answers, e.g., "have you noticed any change in your health?"	0.00% 0/9 • Subjects were monitored for Adverse Events from Study Day 1 through Day 28 of the study During each visit, the Investigator questioned the subject about adverse events using an open question taking care not to influence the subject's answers, e.g., "have you noticed any change in your health?"	0.00% 0/9 • Subjects were monitored for Adverse Events from Study Day 1 through Day 28 of the study During each visit, the Investigator questioned the subject about adverse events using an open question taking care not to influence the subject's answers, e.g., "have you noticed any change in your health?"	0.00% 0/9 • Subjects were monitored for Adverse Events from Study Day 1 through Day 28 of the study During each visit, the Investigator questioned the subject about adverse events using an open question taking care not to influence the subject's answers, e.g., "have you noticed any change in your health?"
Nervous system disorders Headache	11.1% 1/9 • Subjects were monitored for Adverse Events from Study Day 1 through Day 28 of the study During each visit, the Investigator questioned the subject about adverse events using an open question taking care not to influence the subject's answers, e.g., "have you noticed any change in your health?"	0.00% 0/9 • Subjects were monitored for Adverse Events from Study Day 1 through Day 28 of the study During each visit, the Investigator questioned the subject about adverse events using an open question taking care not to influence the subject's answers, e.g., "have you noticed any change in your health?"	0.00% 0/9 • Subjects were monitored for Adverse Events from Study Day 1 through Day 28 of the study During each visit, the Investigator questioned the subject about adverse events using an open question taking care not to influence the subject's answers, e.g., "have you noticed any change in your health?"	0.00% 0/9 • Subjects were monitored for Adverse Events from Study Day 1 through Day 28 of the study During each visit, the Investigator questioned the subject about adverse events using an open question taking care not to influence the subject's answers, e.g., "have you noticed any change in your health?"
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	11.1% 1/9 • Subjects were monitored for Adverse Events from Study Day 1 through Day 28 of the study During each visit, the Investigator questioned the subject about adverse events using an open question taking care not to influence the subject's answers, e.g., "have you noticed any change in your health?"	0.00% 0/9 • Subjects were monitored for Adverse Events from Study Day 1 through Day 28 of the study During each visit, the Investigator questioned the subject about adverse events using an open question taking care not to influence the subject's answers, e.g., "have you noticed any change in your health?"	0.00% 0/9 • Subjects were monitored for Adverse Events from Study Day 1 through Day 28 of the study During each visit, the Investigator questioned the subject about adverse events using an open question taking care not to influence the subject's answers, e.g., "have you noticed any change in your health?"	0.00% 0/9 • Subjects were monitored for Adverse Events from Study Day 1 through Day 28 of the study During each visit, the Investigator questioned the subject about adverse events using an open question taking care not to influence the subject's answers, e.g., "have you noticed any change in your health?"
Nervous system disorders Migraine	11.1% 1/9 • Subjects were monitored for Adverse Events from Study Day 1 through Day 28 of the study During each visit, the Investigator questioned the subject about adverse events using an open question taking care not to influence the subject's answers, e.g., "have you noticed any change in your health?"	0.00% 0/9 • Subjects were monitored for Adverse Events from Study Day 1 through Day 28 of the study During each visit, the Investigator questioned the subject about adverse events using an open question taking care not to influence the subject's answers, e.g., "have you noticed any change in your health?"	0.00% 0/9 • Subjects were monitored for Adverse Events from Study Day 1 through Day 28 of the study During each visit, the Investigator questioned the subject about adverse events using an open question taking care not to influence the subject's answers, e.g., "have you noticed any change in your health?"	0.00% 0/9 • Subjects were monitored for Adverse Events from Study Day 1 through Day 28 of the study During each visit, the Investigator questioned the subject about adverse events using an open question taking care not to influence the subject's answers, e.g., "have you noticed any change in your health?"
Infections and infestations Urinary Tract infection	11.1% 1/9 • Subjects were monitored for Adverse Events from Study Day 1 through Day 28 of the study During each visit, the Investigator questioned the subject about adverse events using an open question taking care not to influence the subject's answers, e.g., "have you noticed any change in your health?"	0.00% 0/9 • Subjects were monitored for Adverse Events from Study Day 1 through Day 28 of the study During each visit, the Investigator questioned the subject about adverse events using an open question taking care not to influence the subject's answers, e.g., "have you noticed any change in your health?"	0.00% 0/9 • Subjects were monitored for Adverse Events from Study Day 1 through Day 28 of the study During each visit, the Investigator questioned the subject about adverse events using an open question taking care not to influence the subject's answers, e.g., "have you noticed any change in your health?"	0.00% 0/9 • Subjects were monitored for Adverse Events from Study Day 1 through Day 28 of the study During each visit, the Investigator questioned the subject about adverse events using an open question taking care not to influence the subject's answers, e.g., "have you noticed any change in your health?"
General disorders Pyrexia	11.1% 1/9 • Subjects were monitored for Adverse Events from Study Day 1 through Day 28 of the study During each visit, the Investigator questioned the subject about adverse events using an open question taking care not to influence the subject's answers, e.g., "have you noticed any change in your health?"	0.00% 0/9 • Subjects were monitored for Adverse Events from Study Day 1 through Day 28 of the study During each visit, the Investigator questioned the subject about adverse events using an open question taking care not to influence the subject's answers, e.g., "have you noticed any change in your health?"	0.00% 0/9 • Subjects were monitored for Adverse Events from Study Day 1 through Day 28 of the study During each visit, the Investigator questioned the subject about adverse events using an open question taking care not to influence the subject's answers, e.g., "have you noticed any change in your health?"	0.00% 0/9 • Subjects were monitored for Adverse Events from Study Day 1 through Day 28 of the study During each visit, the Investigator questioned the subject about adverse events using an open question taking care not to influence the subject's answers, e.g., "have you noticed any change in your health?"
Gastrointestinal disorders Vomiting	11.1% 1/9 • Subjects were monitored for Adverse Events from Study Day 1 through Day 28 of the study During each visit, the Investigator questioned the subject about adverse events using an open question taking care not to influence the subject's answers, e.g., "have you noticed any change in your health?"	0.00% 0/9 • Subjects were monitored for Adverse Events from Study Day 1 through Day 28 of the study During each visit, the Investigator questioned the subject about adverse events using an open question taking care not to influence the subject's answers, e.g., "have you noticed any change in your health?"	0.00% 0/9 • Subjects were monitored for Adverse Events from Study Day 1 through Day 28 of the study During each visit, the Investigator questioned the subject about adverse events using an open question taking care not to influence the subject's answers, e.g., "have you noticed any change in your health?"	0.00% 0/9 • Subjects were monitored for Adverse Events from Study Day 1 through Day 28 of the study During each visit, the Investigator questioned the subject about adverse events using an open question taking care not to influence the subject's answers, e.g., "have you noticed any change in your health?"
Injury, poisoning and procedural complications Arthropod Sting	0.00% 0/9 • Subjects were monitored for Adverse Events from Study Day 1 through Day 28 of the study During each visit, the Investigator questioned the subject about adverse events using an open question taking care not to influence the subject's answers, e.g., "have you noticed any change in your health?"	11.1% 1/9 • Subjects were monitored for Adverse Events from Study Day 1 through Day 28 of the study During each visit, the Investigator questioned the subject about adverse events using an open question taking care not to influence the subject's answers, e.g., "have you noticed any change in your health?"	0.00% 0/9 • Subjects were monitored for Adverse Events from Study Day 1 through Day 28 of the study During each visit, the Investigator questioned the subject about adverse events using an open question taking care not to influence the subject's answers, e.g., "have you noticed any change in your health?"	0.00% 0/9 • Subjects were monitored for Adverse Events from Study Day 1 through Day 28 of the study During each visit, the Investigator questioned the subject about adverse events using an open question taking care not to influence the subject's answers, e.g., "have you noticed any change in your health?"
Infections and infestations Streptococcal Infection	0.00% 0/9 • Subjects were monitored for Adverse Events from Study Day 1 through Day 28 of the study During each visit, the Investigator questioned the subject about adverse events using an open question taking care not to influence the subject's answers, e.g., "have you noticed any change in your health?"	11.1% 1/9 • Subjects were monitored for Adverse Events from Study Day 1 through Day 28 of the study During each visit, the Investigator questioned the subject about adverse events using an open question taking care not to influence the subject's answers, e.g., "have you noticed any change in your health?"	0.00% 0/9 • Subjects were monitored for Adverse Events from Study Day 1 through Day 28 of the study During each visit, the Investigator questioned the subject about adverse events using an open question taking care not to influence the subject's answers, e.g., "have you noticed any change in your health?"	0.00% 0/9 • Subjects were monitored for Adverse Events from Study Day 1 through Day 28 of the study During each visit, the Investigator questioned the subject about adverse events using an open question taking care not to influence the subject's answers, e.g., "have you noticed any change in your health?"
Infections and infestations Herpes zoster	0.00% 0/9 • Subjects were monitored for Adverse Events from Study Day 1 through Day 28 of the study During each visit, the Investigator questioned the subject about adverse events using an open question taking care not to influence the subject's answers, e.g., "have you noticed any change in your health?"	0.00% 0/9 • Subjects were monitored for Adverse Events from Study Day 1 through Day 28 of the study During each visit, the Investigator questioned the subject about adverse events using an open question taking care not to influence the subject's answers, e.g., "have you noticed any change in your health?"	11.1% 1/9 • Subjects were monitored for Adverse Events from Study Day 1 through Day 28 of the study During each visit, the Investigator questioned the subject about adverse events using an open question taking care not to influence the subject's answers, e.g., "have you noticed any change in your health?"	0.00% 0/9 • Subjects were monitored for Adverse Events from Study Day 1 through Day 28 of the study During each visit, the Investigator questioned the subject about adverse events using an open question taking care not to influence the subject's answers, e.g., "have you noticed any change in your health?"
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/9 • Subjects were monitored for Adverse Events from Study Day 1 through Day 28 of the study During each visit, the Investigator questioned the subject about adverse events using an open question taking care not to influence the subject's answers, e.g., "have you noticed any change in your health?"	0.00% 0/9 • Subjects were monitored for Adverse Events from Study Day 1 through Day 28 of the study During each visit, the Investigator questioned the subject about adverse events using an open question taking care not to influence the subject's answers, e.g., "have you noticed any change in your health?"	11.1% 1/9 • Subjects were monitored for Adverse Events from Study Day 1 through Day 28 of the study During each visit, the Investigator questioned the subject about adverse events using an open question taking care not to influence the subject's answers, e.g., "have you noticed any change in your health?"	0.00% 0/9 • Subjects were monitored for Adverse Events from Study Day 1 through Day 28 of the study During each visit, the Investigator questioned the subject about adverse events using an open question taking care not to influence the subject's answers, e.g., "have you noticed any change in your health?"
Respiratory, thoracic and mediastinal disorders Paranasal sinus discomfort	0.00% 0/9 • Subjects were monitored for Adverse Events from Study Day 1 through Day 28 of the study During each visit, the Investigator questioned the subject about adverse events using an open question taking care not to influence the subject's answers, e.g., "have you noticed any change in your health?"	0.00% 0/9 • Subjects were monitored for Adverse Events from Study Day 1 through Day 28 of the study During each visit, the Investigator questioned the subject about adverse events using an open question taking care not to influence the subject's answers, e.g., "have you noticed any change in your health?"	11.1% 1/9 • Subjects were monitored for Adverse Events from Study Day 1 through Day 28 of the study During each visit, the Investigator questioned the subject about adverse events using an open question taking care not to influence the subject's answers, e.g., "have you noticed any change in your health?"	0.00% 0/9 • Subjects were monitored for Adverse Events from Study Day 1 through Day 28 of the study During each visit, the Investigator questioned the subject about adverse events using an open question taking care not to influence the subject's answers, e.g., "have you noticed any change in your health?"
Respiratory, thoracic and mediastinal disorders Nasal Congestion	0.00% 0/9 • Subjects were monitored for Adverse Events from Study Day 1 through Day 28 of the study During each visit, the Investigator questioned the subject about adverse events using an open question taking care not to influence the subject's answers, e.g., "have you noticed any change in your health?"	0.00% 0/9 • Subjects were monitored for Adverse Events from Study Day 1 through Day 28 of the study During each visit, the Investigator questioned the subject about adverse events using an open question taking care not to influence the subject's answers, e.g., "have you noticed any change in your health?"	0.00% 0/9 • Subjects were monitored for Adverse Events from Study Day 1 through Day 28 of the study During each visit, the Investigator questioned the subject about adverse events using an open question taking care not to influence the subject's answers, e.g., "have you noticed any change in your health?"	11.1% 1/9 • Subjects were monitored for Adverse Events from Study Day 1 through Day 28 of the study During each visit, the Investigator questioned the subject about adverse events using an open question taking care not to influence the subject's answers, e.g., "have you noticed any change in your health?"
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/9 • Subjects were monitored for Adverse Events from Study Day 1 through Day 28 of the study During each visit, the Investigator questioned the subject about adverse events using an open question taking care not to influence the subject's answers, e.g., "have you noticed any change in your health?"	0.00% 0/9 • Subjects were monitored for Adverse Events from Study Day 1 through Day 28 of the study During each visit, the Investigator questioned the subject about adverse events using an open question taking care not to influence the subject's answers, e.g., "have you noticed any change in your health?"	0.00% 0/9 • Subjects were monitored for Adverse Events from Study Day 1 through Day 28 of the study During each visit, the Investigator questioned the subject about adverse events using an open question taking care not to influence the subject's answers, e.g., "have you noticed any change in your health?"	11.1% 1/9 • Subjects were monitored for Adverse Events from Study Day 1 through Day 28 of the study During each visit, the Investigator questioned the subject about adverse events using an open question taking care not to influence the subject's answers, e.g., "have you noticed any change in your health?"