Trial Outcomes & Findings for Profiling the Skin Microbiome in Response to Altreno in Acne Patients (NCT NCT04548349)

Last Updated: 2024-02-06

Results Overview

The primary outcome measures the relative abundance of Kingella after treatment with Altreno in acne patients vs without treatment in healthy subjects. The relative abundance was represented as centered log ratio (CLR) transformation. These values are all relative terms centered around 0, more negative means less abundant in comparison. More positive means more abundant in comparison.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

25 participants

Primary outcome timeframe

Baseline, 90 days after treatment, and followed by 30 days of no treatment

Results posted on

2024-02-06

Participant Flow

The BPO arm was not included in this reporting. We only recruited 1 subject in this arm and did not reach the sufficient number needed to make meaningful comparisons. It was decided that we would proceed with comparing no acne vs. acne treated with Altreno. We did not pursue any downstream processing of the samples collected from that 1 patient, so no results are available for this arm. \*\*\*The BPO Arm, 1 subject enrolled, but no analysis formed.\*\*\*

Participant milestones

Participant milestones
Measure	Altreno Group Altreno (0.05% lotion): Acne patients will be assigned to Altreno once daily.	Control Group During the entire study period, the subjects in the control group will not be allowed to use any antibacterial wash, other than approved OTC cleansers.	BPO Group BPO 2.5% leave-on gel: Acne patients will be assigned to BPO once daily.
Overall Study STARTED	12	12	1
Overall Study COMPLETED	8	8	1
Overall Study NOT COMPLETED	4	4	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

We are not reporting the baseline relative abundance for the overall population. The relative abundance is calculated for control group and for acne group separately. Because the outcome measure that we are looking for is the change from the baseline relative abundance after intervention within each group, not as the overall population.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Altreno Group n=12 Participants Altreno: Acne patients will be assigned to Altreno once daily.	Control Group n=12 Participants During the entire study period, the subjects in the control group will not be allowed to use any antibacterial wash, other than approved OTC cleansers.	BPO Group n=1 Participants BPO: Acne patients will be assigned to BPO once daily.	Total n=25 Participants Total of all reporting groups
Age, Continuous	28.5 years STANDARD_DEVIATION 6.4 • n=12 Participants	31.8 years STANDARD_DEVIATION 4.9 • n=12 Participants	26 years STANDARD_DEVIATION 0 • n=1 Participants	30.2 years STANDARD_DEVIATION 5.8 • n=25 Participants
Sex: Female, Male Female	11 Participants n=12 Participants	6 Participants n=12 Participants	1 Participants n=1 Participants	18 Participants n=25 Participants
Sex: Female, Male Male	1 Participants n=12 Participants	6 Participants n=12 Participants	0 Participants n=1 Participants	7 Participants n=25 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=12 Participants	1 Participants n=12 Participants	0 Participants n=1 Participants	2 Participants n=25 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=12 Participants	11 Participants n=12 Participants	1 Participants n=1 Participants	23 Participants n=25 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=12 Participants	0 Participants n=12 Participants	0 Participants n=1 Participants	0 Participants n=25 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=12 Participants	0 Participants n=12 Participants	0 Participants n=1 Participants	0 Participants n=25 Participants
Race (NIH/OMB) Asian	1 Participants n=12 Participants	0 Participants n=12 Participants	0 Participants n=1 Participants	1 Participants n=25 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=12 Participants	0 Participants n=12 Participants	0 Participants n=1 Participants	0 Participants n=25 Participants
Race (NIH/OMB) Black or African American	1 Participants n=12 Participants	0 Participants n=12 Participants	0 Participants n=1 Participants	1 Participants n=25 Participants
Race (NIH/OMB) White	9 Participants n=12 Participants	12 Participants n=12 Participants	1 Participants n=1 Participants	22 Participants n=25 Participants
Race (NIH/OMB) More than one race	0 Participants n=12 Participants	0 Participants n=12 Participants	0 Participants n=1 Participants	0 Participants n=25 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=12 Participants	0 Participants n=12 Participants	0 Participants n=1 Participants	1 Participants n=25 Participants
Relative Abundance Altreno Group	3.29 Relative Abundance n=12 Participants • We are not reporting the baseline relative abundance for the overall population. The relative abundance is calculated for control group and for acne group separately. Because the outcome measure that we are looking for is the change from the baseline relative abundance after intervention within each group, not as the overall population.	—	—	3.29 Relative Abundance n=12 Participants • We are not reporting the baseline relative abundance for the overall population. The relative abundance is calculated for control group and for acne group separately. Because the outcome measure that we are looking for is the change from the baseline relative abundance after intervention within each group, not as the overall population.
Relative Abundance Control Group	—	-2.49 Relative Abundance n=12 Participants • We are not reporting the baseline relative abundance for the overall population. The relative abundance is calculated for control group and for acne group separately. Because the outcome measure that we are looking for is the change from the baseline relative abundance after intervention within each group, not as the overall population.	—	-2.49 Relative Abundance n=12 Participants • We are not reporting the baseline relative abundance for the overall population. The relative abundance is calculated for control group and for acne group separately. Because the outcome measure that we are looking for is the change from the baseline relative abundance after intervention within each group, not as the overall population.

PRIMARY outcome

Timeframe: Baseline, 90 days after treatment, and followed by 30 days of no treatment

Population: The participants analyzed differ because of lost to follow-up and/or not sufficient DNA yield for downstream microbiome sequencing.

Outcome measures

Outcome measures
Measure	Altreno Group n=11 Participants Altreno: Acne patients will be assigned to Altreno once daily.	Control Group n=10 Participants During the entire study period, the subjects in the control group will not be allowed to use any antibacterial wash, other than approved OTC cleansers.
CLR-transformed Abundance of Any Significant Taxa Baseline	3.29 Relative Abundance Interval 2.38 to 5.32	-2.49 Relative Abundance Interval -3.24 to -2.19
CLR-transformed Abundance of Any Significant Taxa +90 days from baseline	-1.59 Relative Abundance Interval -2.98 to 1.88	-2.75 Relative Abundance Interval -2.92 to -2.21
CLR-transformed Abundance of Any Significant Taxa +120 days from baseline	-1.98 Relative Abundance Interval -3.51 to 3.37	—

Adverse Events

Altreno Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

BPO Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jean S. McGee, MD, PhD

Beth Israel Deaconess Medical Center

Phone: (617) 667-5834

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place