Trial Outcomes & Findings for Targeted Microbiome Transplant in Atopic Dermatitis (NCT NCT03151148)
NCT ID: NCT03151148
Last Updated: 2020-08-17
Results Overview
Per-participant daily event rate of TEAEs was calculated as the number of events per-participant-days at risk. Statistical method employed: Poisson generalized linear model with a log link function and including the natural log of the number of days active in the study during Day 0 to Day 8.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
54 participants
Primary outcome timeframe
Day 0 to Day 8
Results posted on
2020-08-17
Participant Flow
Recruitment of patients with active atopic dermatitis took place between 20 September 2017 through 24 April 2019 at 2 clinical centers in the US: National Jewish Health: Division of Pediatric Allergy and Clinical Immunology and University of California - San Diego
Screened S. aureus positive participants requiring medication/therapy washout of ≤14 days to meet inclusion/exclusion criteria were randomized within 14 days of screening. Screened S. aureus positive participants requiring medication/therapy washout \> 14 days, completed a Repeat Culture Visit after a washout, to confirm S. aureus colonization.
Participant milestones
| Measure |
TMT Lotion
The targeted microbiome transplant (TMT) lotion was provided in single-dose sealed packets.
Participants applied 2 grams of TMT to each ventral aspect of their arm (wrist to upper humerus). Frequency of lotion application: topical application administered twice daily for one week.
|
Placebo Lotion
Placebo lotion was provided in single-dose sealed packets.
Participants applied 2 grams of placebo to each ventral aspect of their arm (wrist to upper humerus). Frequency of lotion application: topical application administered twice daily for one week.
|
|---|---|---|
|
Overall Study
STARTED
|
36
|
18
|
|
Overall Study
COMPLETED
|
34
|
18
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
TMT Lotion
The targeted microbiome transplant (TMT) lotion was provided in single-dose sealed packets.
Participants applied 2 grams of TMT to each ventral aspect of their arm (wrist to upper humerus). Frequency of lotion application: topical application administered twice daily for one week.
|
Placebo Lotion
Placebo lotion was provided in single-dose sealed packets.
Participants applied 2 grams of placebo to each ventral aspect of their arm (wrist to upper humerus). Frequency of lotion application: topical application administered twice daily for one week.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Targeted Microbiome Transplant in Atopic Dermatitis
Baseline characteristics by cohort
| Measure |
TMT Lotion
n=36 Participants
The targeted microbiome transplant (TMT) lotion was provided in single-dose sealed packets.
Participants applied 2 grams of TMT to each ventral aspect of their arm (wrist to upper humerus). Frequency of lotion application: topical application administered twice daily for one week.
|
Placebo Lotion
n=18 Participants
Placebo lotion was provided in single-dose sealed packets.
Participants applied 2 grams of placebo to each ventral aspect of their arm (wrist to upper humerus). Frequency of lotion application: topical application administered twice daily for one week.
|
Total
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=113 Participants
|
1 Participants
n=163 Participants
|
2 Participants
n=160 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
35 Participants
n=113 Participants
|
17 Participants
n=163 Participants
|
52 Participants
n=160 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
|
Age, Continuous
|
29.4 Age Continuous (years)
STANDARD_DEVIATION 12.16 • n=113 Participants
|
26.6 Age Continuous (years)
STANDARD_DEVIATION 10.18 • n=163 Participants
|
28.4 Age Continuous (years)
STANDARD_DEVIATION 11.52 • n=160 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=113 Participants
|
12 Participants
n=163 Participants
|
29 Participants
n=160 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=113 Participants
|
6 Participants
n=163 Participants
|
25 Participants
n=160 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=113 Participants
|
3 Participants
n=163 Participants
|
10 Participants
n=160 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=113 Participants
|
15 Participants
n=163 Participants
|
44 Participants
n=160 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
|
Race (NIH/OMB)
Asian
|
12 Participants
n=113 Participants
|
7 Participants
n=163 Participants
|
19 Participants
n=160 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=113 Participants
|
1 Participants
n=163 Participants
|
5 Participants
n=160 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=113 Participants
|
8 Participants
n=163 Participants
|
23 Participants
n=160 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=113 Participants
|
2 Participants
n=163 Participants
|
5 Participants
n=160 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
2 Participants
n=160 Participants
|
|
Region of Enrollment
United States
|
36 Participants
n=113 Participants
|
18 Participants
n=163 Participants
|
54 Participants
n=160 Participants
|
|
Screening Staphylococcus aureus (S. aureus) blood agar growth score
1
|
11 Participants
n=113 Participants
|
5 Participants
n=163 Participants
|
16 Participants
n=160 Participants
|
|
Screening Staphylococcus aureus (S. aureus) blood agar growth score
2
|
9 Participants
n=113 Participants
|
3 Participants
n=163 Participants
|
12 Participants
n=160 Participants
|
|
Screening Staphylococcus aureus (S. aureus) blood agar growth score
3
|
5 Participants
n=113 Participants
|
2 Participants
n=163 Participants
|
7 Participants
n=160 Participants
|
|
Screening Staphylococcus aureus (S. aureus) blood agar growth score
4
|
11 Participants
n=113 Participants
|
8 Participants
n=163 Participants
|
19 Participants
n=160 Participants
|
PRIMARY outcome
Timeframe: Day 0 to Day 8Population: Safety sample: All participants who were randomized and received any doses of their assigned intervention.
Per-participant daily event rate of TEAEs was calculated as the number of events per-participant-days at risk. Statistical method employed: Poisson generalized linear model with a log link function and including the natural log of the number of days active in the study during Day 0 to Day 8.
Outcome measures
| Measure |
Targeted Microbiome Transplant (TMT)
n=36 Participants
The targeted microbiome transplant (TMT) lotion was provided in single-dose sealed packets.
Participants applied 2 grams of TMT to each ventral aspect of their arm (wrist to upper humerus). Frequency of lotion application: topical application administered twice daily for one week.
|
Placebo Lotion
n=18 Participants
Placebo lotion was provided in single-dose sealed packets.
Participants applied 2 grams of placebo to each ventral aspect of their arm (wrist to upper humerus). Frequency of lotion application: topical application administered twice daily for one week.
|
|---|---|---|
|
Per-Participant Daily Event Rate: Serious and Non-Serious Treatment Emergent Adverse Events (TEAEs)
|
0.19 events per-participant-day
Interval 0.12 to 0.29
|
0.34 events per-participant-day
Interval 0.2 to 0.58
|
SECONDARY outcome
Timeframe: Day 0 (after initiation of study treatment) through Day 8 (last day of study treatment)Population: Safety sample: All participants who were randomized and received any doses of their assigned intervention.
The number of participants for which at least one treatment emergent adverse event (AE), defined as an increase in grade from baseline or from the last post-baseline value that does not meet grading criteria, was reported during the measure time frame.
Outcome measures
| Measure |
Targeted Microbiome Transplant (TMT)
n=36 Participants
The targeted microbiome transplant (TMT) lotion was provided in single-dose sealed packets.
Participants applied 2 grams of TMT to each ventral aspect of their arm (wrist to upper humerus). Frequency of lotion application: topical application administered twice daily for one week.
|
Placebo Lotion
n=18 Participants
Placebo lotion was provided in single-dose sealed packets.
Participants applied 2 grams of placebo to each ventral aspect of their arm (wrist to upper humerus). Frequency of lotion application: topical application administered twice daily for one week.
|
|---|---|---|
|
The Occurrence of at Least One Serious or Non-Serious Treatment Emergent Adverse Event (TEAE)
|
20 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: Screening (up to 38 days before initiation of treatment) to Day 38 (last day of study participation)Population: Safety sample (all participants who are randomized and receive any amount of study drug)
Per-participant daily event rate of serious and non-serious AEs was calculated by the number of events per-participant days active in the study during Screening to Day 38.
Outcome measures
| Measure |
Targeted Microbiome Transplant (TMT)
n=36 Participants
The targeted microbiome transplant (TMT) lotion was provided in single-dose sealed packets.
Participants applied 2 grams of TMT to each ventral aspect of their arm (wrist to upper humerus). Frequency of lotion application: topical application administered twice daily for one week.
|
Placebo Lotion
n=18 Participants
Placebo lotion was provided in single-dose sealed packets.
Participants applied 2 grams of placebo to each ventral aspect of their arm (wrist to upper humerus). Frequency of lotion application: topical application administered twice daily for one week.
|
|---|---|---|
|
Per-Participant Daily Event Rate of Serious and Non-Serious Adverse Events (AEs)
|
0.06 events per-participant-day
Interval 0.04 to 0.09
|
0.09 events per-participant-day
Interval 0.06 to 0.15
|
SECONDARY outcome
Timeframe: Screening (up to 38 days before initiation of treatment) to Day 38 (last day of study participation)Population: Safety sample (all participants who are randomized and receive any amount of study drug)
The number of participants for which at least one adverse event (AE) was reported
Outcome measures
| Measure |
Targeted Microbiome Transplant (TMT)
n=36 Participants
The targeted microbiome transplant (TMT) lotion was provided in single-dose sealed packets.
Participants applied 2 grams of TMT to each ventral aspect of their arm (wrist to upper humerus). Frequency of lotion application: topical application administered twice daily for one week.
|
Placebo Lotion
n=18 Participants
Placebo lotion was provided in single-dose sealed packets.
Participants applied 2 grams of placebo to each ventral aspect of their arm (wrist to upper humerus). Frequency of lotion application: topical application administered twice daily for one week.
|
|---|---|---|
|
The Occurrence of at Least One Serious or Non-Serious Adverse Event (AE)
|
23 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: Days 0, 4, 7, 8 and 11Population: Modified Intention-to-Treat (MITT) sample includes all randomized participants who provided skin swabs on Day 0 and Day 7 and administered 75 percent of doses of the study drug.
The eczema area and severity index (EASI) for the ventral arms is a composite score measuring physical signs of atopic dermatitis. The scale ranges from 0-18. The components measuring severity are four signs/symptoms of atopic dermatitis: erythema, papulation, excoriation, and lichenification each scored on a scale of 0 (absent) to 3 (severe) for the ventral arms. The component measuring area is the percent area of the ventral arms with atopic dermatitis lesions scored on a scale of 0 (0%) to 6 (90-100%).
Outcome measures
| Measure |
Targeted Microbiome Transplant (TMT)
n=35 Participants
The targeted microbiome transplant (TMT) lotion was provided in single-dose sealed packets.
Participants applied 2 grams of TMT to each ventral aspect of their arm (wrist to upper humerus). Frequency of lotion application: topical application administered twice daily for one week.
|
Placebo Lotion
n=17 Participants
Placebo lotion was provided in single-dose sealed packets.
Participants applied 2 grams of placebo to each ventral aspect of their arm (wrist to upper humerus). Frequency of lotion application: topical application administered twice daily for one week.
|
|---|---|---|
|
The Eczema Area and Severity Index (EASI) Score of the Ventral Arms at Specific Days During the Measure Time Frame
Day 0
|
2.5 units on a scale
Standard Deviation 1.47
|
2.2 units on a scale
Standard Deviation 1.06
|
|
The Eczema Area and Severity Index (EASI) Score of the Ventral Arms at Specific Days During the Measure Time Frame
Day 4
|
2.5 units on a scale
Standard Deviation 1.6
|
2.2 units on a scale
Standard Deviation 0.98
|
|
The Eczema Area and Severity Index (EASI) Score of the Ventral Arms at Specific Days During the Measure Time Frame
Day 7
|
2.2 units on a scale
Standard Deviation 1.51
|
1.9 units on a scale
Standard Deviation 1.11
|
|
The Eczema Area and Severity Index (EASI) Score of the Ventral Arms at Specific Days During the Measure Time Frame
Day 8
|
2.1 units on a scale
Standard Deviation 1.5
|
1.9 units on a scale
Standard Deviation 1.14
|
|
The Eczema Area and Severity Index (EASI) Score of the Ventral Arms at Specific Days During the Measure Time Frame
Day 11
|
2.0 units on a scale
Standard Deviation 1.47
|
1.7 units on a scale
Standard Deviation 1.16
|
SECONDARY outcome
Timeframe: Days 0, 4, 7, 8 and 11Population: Modified Intention-to-Treat (MITT) sample includes all randomized participants who provided skin swabs on Day 0 and Day 7 and administered 75 percent of doses of the study drug.
SCORAD (Severity scoring of Atopic Dermatitis) is a composite severity index comprising A) the amount/extent of body surface area affected; A= 0-100%, B) disease intensity assessed as sum of scores for 6 parameters (erythema, edema/papulation, oozing/crusting, excoriation, lichenification, and dryness), each graded from 0 (none) to 3 (severe); B= 0-18, and C) subjective symptom visual analog assessments for pruritus \[0 (no itch) to 10 (worst imaginable itch)\] and sleep loss \[0 (no sleep loss) to 10 (worst imaginable sleep loss)\] summed for a total symptom score; C=0-20. The SCORAD = A/5 + 7B/2 + C and ranges from 0 (no AD present) to 103 (severe).
Outcome measures
| Measure |
Targeted Microbiome Transplant (TMT)
n=35 Participants
The targeted microbiome transplant (TMT) lotion was provided in single-dose sealed packets.
Participants applied 2 grams of TMT to each ventral aspect of their arm (wrist to upper humerus). Frequency of lotion application: topical application administered twice daily for one week.
|
Placebo Lotion
n=17 Participants
Placebo lotion was provided in single-dose sealed packets.
Participants applied 2 grams of placebo to each ventral aspect of their arm (wrist to upper humerus). Frequency of lotion application: topical application administered twice daily for one week.
|
|---|---|---|
|
The Scoring Atopic Dermatitis (SCORAD) Score at Specific Days During the Measure Time Frame
Day 4
|
48.9 units on a scale
Standard Deviation 13.48
|
45.5 units on a scale
Standard Deviation 11.49
|
|
The Scoring Atopic Dermatitis (SCORAD) Score at Specific Days During the Measure Time Frame
Day 8
|
42.4 units on a scale
Standard Deviation 13.45
|
43.3 units on a scale
Standard Deviation 14.71
|
|
The Scoring Atopic Dermatitis (SCORAD) Score at Specific Days During the Measure Time Frame
Day 0
|
50.0 units on a scale
Standard Deviation 12.82
|
46.5 units on a scale
Standard Deviation 12.76
|
|
The Scoring Atopic Dermatitis (SCORAD) Score at Specific Days During the Measure Time Frame
Day 7
|
43.8 units on a scale
Standard Deviation 13.75
|
40.7 units on a scale
Standard Deviation 12.96
|
|
The Scoring Atopic Dermatitis (SCORAD) Score at Specific Days During the Measure Time Frame
Day 11
|
40.5 units on a scale
Standard Deviation 14.94
|
39.4 units on a scale
Standard Deviation 15.13
|
SECONDARY outcome
Timeframe: Days 0 and 7Population: Modified Intention-to-Treat (MITT) sample includes all randomized participants who provided skin swabs on Day 0 and Day 7 and administered 75 percent of doses of the study drug.
The Rajka \& Langeland (RL) eczema severity score is a simple assessment of AD severity as well as the classification of AD into mild, moderate, or severe. The score is based on the grading of: (i) eczema extent based on % body area affected, (ii) eczema course based on the number of months with remission during the previous year, and (iii) eczema intensity expressed in terms of nocturnal sleep disturbance due to itch. Each parameter is scored on a scale from 1-3, and the scores are summed. The RL score ranges from 3 to 9 (mild, 3-4; moderate, 4.5-7.5; severe, 8-9)
Outcome measures
| Measure |
Targeted Microbiome Transplant (TMT)
n=35 Participants
The targeted microbiome transplant (TMT) lotion was provided in single-dose sealed packets.
Participants applied 2 grams of TMT to each ventral aspect of their arm (wrist to upper humerus). Frequency of lotion application: topical application administered twice daily for one week.
|
Placebo Lotion
n=17 Participants
Placebo lotion was provided in single-dose sealed packets.
Participants applied 2 grams of placebo to each ventral aspect of their arm (wrist to upper humerus). Frequency of lotion application: topical application administered twice daily for one week.
|
|---|---|---|
|
The Rajka-Langeland (RL) Score at Specific Days During the Measure Time Frame
Day 0
|
7.0 units on a scale
Standard Deviation 1.52
|
6.6 units on a scale
Standard Deviation 1.41
|
|
The Rajka-Langeland (RL) Score at Specific Days During the Measure Time Frame
Day 7
|
6.8 units on a scale
Standard Deviation 1.59
|
6.5 units on a scale
Standard Deviation 1.50
|
SECONDARY outcome
Timeframe: Days 0, 4, 7, 8 and 11Population: Modified Intention-to-Treat (MITT) sample includes all randomized participants who provided skin swabs on Day 0 and Day 7 and administered 75 percent of doses of the study drug.
The pruritus visual analog scale (VAS) asks participants to rate the status of their Pruritus based on the severity of their itch. Scores range from 0 to 10 (0 = no itch, 10 = worst imaginable itch)
Outcome measures
| Measure |
Targeted Microbiome Transplant (TMT)
n=35 Participants
The targeted microbiome transplant (TMT) lotion was provided in single-dose sealed packets.
Participants applied 2 grams of TMT to each ventral aspect of their arm (wrist to upper humerus). Frequency of lotion application: topical application administered twice daily for one week.
|
Placebo Lotion
n=17 Participants
Placebo lotion was provided in single-dose sealed packets.
Participants applied 2 grams of placebo to each ventral aspect of their arm (wrist to upper humerus). Frequency of lotion application: topical application administered twice daily for one week.
|
|---|---|---|
|
The Pruritus Visual Analog Scale (VAS) Score of the Ventral Arms at Specific Days During the Measure Time Frame
Day 0
|
6.1 units on a scale
Standard Deviation 2.26
|
5.3 units on a scale
Standard Deviation 2.59
|
|
The Pruritus Visual Analog Scale (VAS) Score of the Ventral Arms at Specific Days During the Measure Time Frame
Day 4
|
5.7 units on a scale
Standard Deviation 2.44
|
4.7 units on a scale
Standard Deviation 2.56
|
|
The Pruritus Visual Analog Scale (VAS) Score of the Ventral Arms at Specific Days During the Measure Time Frame
Day 7
|
4.2 units on a scale
Standard Deviation 2.46
|
3.4 units on a scale
Standard Deviation 2.40
|
|
The Pruritus Visual Analog Scale (VAS) Score of the Ventral Arms at Specific Days During the Measure Time Frame
Day 8
|
3.3 units on a scale
Standard Deviation 2.08
|
3.3 units on a scale
Standard Deviation 2.66
|
|
The Pruritus Visual Analog Scale (VAS) Score of the Ventral Arms at Specific Days During the Measure Time Frame
Day 11
|
3.2 units on a scale
Standard Deviation 2.38
|
2.9 units on a scale
Standard Deviation 2.66
|
SECONDARY outcome
Timeframe: Days 0, 4, 7, 8 and 11Population: Modified Intention-to-Treat (MITT) sample includes all randomized participants who provided skin swabs on Day 0 and Day 7 and administered 75 percent of doses of the study drug.
Amount of CoNS present on lesional and non-lesional skin measured by Colony Forming Units per centimeter squared (CFU/cm\^2)
Outcome measures
| Measure |
Targeted Microbiome Transplant (TMT)
n=35 Participants
The targeted microbiome transplant (TMT) lotion was provided in single-dose sealed packets.
Participants applied 2 grams of TMT to each ventral aspect of their arm (wrist to upper humerus). Frequency of lotion application: topical application administered twice daily for one week.
|
Placebo Lotion
n=17 Participants
Placebo lotion was provided in single-dose sealed packets.
Participants applied 2 grams of placebo to each ventral aspect of their arm (wrist to upper humerus). Frequency of lotion application: topical application administered twice daily for one week.
|
|---|---|---|
|
The Abundance of Coagulase Negative Staphylococcal (CoNS) Species, as Measured by Culture, on Lesional and Non-Lesional Skin Within Each Treatment Group
Day 4 - Lesional
|
549.7 CFU/cm^2
Interval 151.99 to 1988.39
|
557.3 CFU/cm^2
Interval 88.14 to 3522.99
|
|
The Abundance of Coagulase Negative Staphylococcal (CoNS) Species, as Measured by Culture, on Lesional and Non-Lesional Skin Within Each Treatment Group
Day 4 - Non-lesional
|
1351.5 CFU/cm^2
Interval 373.52 to 4890.38
|
16.5 CFU/cm^2
Interval 2.6 to 104.03
|
|
The Abundance of Coagulase Negative Staphylococcal (CoNS) Species, as Measured by Culture, on Lesional and Non-Lesional Skin Within Each Treatment Group
Day 11 - Lesional
|
173.0 CFU/cm^2
Interval 47.83 to 625.77
|
15.6 CFU/cm^2
Interval 2.47 to 98.74
|
|
The Abundance of Coagulase Negative Staphylococcal (CoNS) Species, as Measured by Culture, on Lesional and Non-Lesional Skin Within Each Treatment Group
Day 11 - Non-Lesional
|
102.0 CFU/cm^2
Interval 28.2 to 369.23
|
8.8 CFU/cm^2
Interval 1.39 to 55.36
|
|
The Abundance of Coagulase Negative Staphylococcal (CoNS) Species, as Measured by Culture, on Lesional and Non-Lesional Skin Within Each Treatment Group
Day 0 - Lesional
|
113.8 CFU/cm^2
Interval 31.45 to 411.48
|
81.8 CFU/cm^2
Interval 12.94 to 517.14
|
|
The Abundance of Coagulase Negative Staphylococcal (CoNS) Species, as Measured by Culture, on Lesional and Non-Lesional Skin Within Each Treatment Group
Day 0 - Non-lesional
|
41.2 CFU/cm^2
Interval 11.4 to 149.23
|
78.8 CFU/cm^2
Interval 12.47 to 498.41
|
|
The Abundance of Coagulase Negative Staphylococcal (CoNS) Species, as Measured by Culture, on Lesional and Non-Lesional Skin Within Each Treatment Group
Day 7 - Lesional
|
2421.9 CFU/cm^2
Interval 669.6 to 8759.87
|
335.2 CFU/cm^2
Interval 53.02 to 2118.99
|
|
The Abundance of Coagulase Negative Staphylococcal (CoNS) Species, as Measured by Culture, on Lesional and Non-Lesional Skin Within Each Treatment Group
Day 7 - Non-lesional
|
2363.5 CFU/cm^2
Interval 653.2 to 8552.23
|
28.0 CFU/cm^2
Interval 4.43 to 176.98
|
|
The Abundance of Coagulase Negative Staphylococcal (CoNS) Species, as Measured by Culture, on Lesional and Non-Lesional Skin Within Each Treatment Group
Day 8 - Lesional
|
371.0 CFU/cm^2
Interval 100.72 to 1366.65
|
19.2 CFU/cm^2
Interval 2.69 to 136.36
|
|
The Abundance of Coagulase Negative Staphylococcal (CoNS) Species, as Measured by Culture, on Lesional and Non-Lesional Skin Within Each Treatment Group
Day 8 - Non-lesional
|
107.8 CFU/cm^2
Interval 29.27 to 397.34
|
20.6 CFU/cm^2
Interval 2.9 to 146.77
|
SECONDARY outcome
Timeframe: At days 0, 4, 7, 8 and 11Population: Data were not collected.
Amount of CoNS on lesional and non-lesional skin measured by qPCR relative colony forming units per centimeter squared \[rCFU/cm\^2\]
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Days 0 (1 hour post treatment), 4, 7, 8 and 11Population: Modified Intention-to-Treat (MITT) sample includes all randomized participants who provided skin swabs on Day 0 and Day 7 and administered 75 percent of doses of the study drug.
Amount of CoNS present on lesional and non-lesional skin measured by Colony Forming Units per centimeter squared (CFU/cm\^2)
Outcome measures
| Measure |
Targeted Microbiome Transplant (TMT)
n=35 Participants
The targeted microbiome transplant (TMT) lotion was provided in single-dose sealed packets.
Participants applied 2 grams of TMT to each ventral aspect of their arm (wrist to upper humerus). Frequency of lotion application: topical application administered twice daily for one week.
|
Placebo Lotion
n=17 Participants
Placebo lotion was provided in single-dose sealed packets.
Participants applied 2 grams of placebo to each ventral aspect of their arm (wrist to upper humerus). Frequency of lotion application: topical application administered twice daily for one week.
|
|---|---|---|
|
The Change From Baseline Levels of Coagulase Negative Staphylococcal (CoNS) Bacteria Abundance, as Measured by Culture, on Lesional and Non-Lesional Skin Within Each Treatment Group
Day 4 - Non-lesional
|
32.77 CFU/cm^2
Interval 5.524 to 194.418
|
0.21 CFU/cm^2
Interval 0.016 to 2.686
|
|
The Change From Baseline Levels of Coagulase Negative Staphylococcal (CoNS) Bacteria Abundance, as Measured by Culture, on Lesional and Non-Lesional Skin Within Each Treatment Group
Day 7 - Lesional
|
21.29 CFU/cm^2
Interval 3.588 to 126.296
|
4.10 CFU/cm^2
Interval 0.318 to 52.725
|
|
The Change From Baseline Levels of Coagulase Negative Staphylococcal (CoNS) Bacteria Abundance, as Measured by Culture, on Lesional and Non-Lesional Skin Within Each Treatment Group
Day 11 - Non-Lesional
|
2.47 CFU/cm^2
Interval 0.417 to 14.679
|
0.11 CFU/cm^2
Interval 0.009 to 1.429
|
|
The Change From Baseline Levels of Coagulase Negative Staphylococcal (CoNS) Bacteria Abundance, as Measured by Culture, on Lesional and Non-Lesional Skin Within Each Treatment Group
Day 0 - Lesional
|
3349.24 CFU/cm^2
Interval 564.555 to 19869.455
|
0.93 CFU/cm^2
Interval 0.072 to 11.936
|
|
The Change From Baseline Levels of Coagulase Negative Staphylococcal (CoNS) Bacteria Abundance, as Measured by Culture, on Lesional and Non-Lesional Skin Within Each Treatment Group
Day 0 - Non-lesional
|
1230.53 CFU/cm^2
Interval 207.421 to 7300.167
|
2.00 CFU/cm^2
Interval 0.155 to 25.694
|
|
The Change From Baseline Levels of Coagulase Negative Staphylococcal (CoNS) Bacteria Abundance, as Measured by Culture, on Lesional and Non-Lesional Skin Within Each Treatment Group
Day 4 - Lesional
|
4.83 CFU/cm^2
Interval 0.815 to 28.668
|
6.81 CFU/cm^2
Interval 0.529 to 87.659
|
|
The Change From Baseline Levels of Coagulase Negative Staphylococcal (CoNS) Bacteria Abundance, as Measured by Culture, on Lesional and Non-Lesional Skin Within Each Treatment Group
Day 7 - Non-lesional
|
57.31 CFU/cm^2
Interval 9.66 to 339.995
|
0.36 CFU/cm^2
Interval 0.028 to 4.569
|
|
The Change From Baseline Levels of Coagulase Negative Staphylococcal (CoNS) Bacteria Abundance, as Measured by Culture, on Lesional and Non-Lesional Skin Within Each Treatment Group
Day 8 - Lesional
|
3.26 CFU/cm^2
Interval 0.542 to 16.609
|
0.23 CFU/cm^2
Interval 0.017 to 3.286
|
|
The Change From Baseline Levels of Coagulase Negative Staphylococcal (CoNS) Bacteria Abundance, as Measured by Culture, on Lesional and Non-Lesional Skin Within Each Treatment Group
Day 8 - Non-lesional
|
2.61 CFU/cm^2
Interval 0.435 to 15.723
|
0.26 CFU/cm^2
Interval 0.019 to 3.67
|
|
The Change From Baseline Levels of Coagulase Negative Staphylococcal (CoNS) Bacteria Abundance, as Measured by Culture, on Lesional and Non-Lesional Skin Within Each Treatment Group
Day 11 - Lesional
|
1.52 CFU/cm^2
Interval 0.256 to 9.022
|
0.19 CFU/cm^2
Interval 0.015 to 2.457
|
SECONDARY outcome
Timeframe: Days 0 (1 hour post treatment), 4, 7, 8 and 11Population: Data were not collected.
Amount of CoNS present on lesional and non-lesional skin measured by qPCR (relative colony forming units per centimeter squared \[rCFU/cm\^2\])
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Days 0 (1 hour post treatment), 4, 7, 8 and 11Population: Modified Intention-to-Treat (MITT) sample includes all randomized participants who provided skin swabs on Day 0 and Day 7 and administered 75 percent of doses of the study drug.
Amount of S. hominis A9 present on lesional and non-lesional skin measured by qPCR (relative colony forming units per centimeter squared \[rCFU/cm\^2\])
Outcome measures
| Measure |
Targeted Microbiome Transplant (TMT)
n=35 Participants
The targeted microbiome transplant (TMT) lotion was provided in single-dose sealed packets.
Participants applied 2 grams of TMT to each ventral aspect of their arm (wrist to upper humerus). Frequency of lotion application: topical application administered twice daily for one week.
|
Placebo Lotion
n=17 Participants
Placebo lotion was provided in single-dose sealed packets.
Participants applied 2 grams of placebo to each ventral aspect of their arm (wrist to upper humerus). Frequency of lotion application: topical application administered twice daily for one week.
|
|---|---|---|
|
The Change From Baseline Levels of S. Hominis A9 Bacteria Abundance, as Measured by Quantitative Polymerase Chain Reaction (qPCR), on Lesional and Non-Lesional Skin Within Each Treatment Group
Day 8 - Lesional
|
691.01 rCFU/cm^2
Interval 324.818 to 1470.024
|
2.31 rCFU/cm^2
Interval 0.745 to 7.188
|
|
The Change From Baseline Levels of S. Hominis A9 Bacteria Abundance, as Measured by Quantitative Polymerase Chain Reaction (qPCR), on Lesional and Non-Lesional Skin Within Each Treatment Group
Day 0 - Lesional
|
9802.91 rCFU/cm^2
Interval 4635.353 to 20731.332
|
0.95 rCFU/cm^2
Interval 0.325 to 2.785
|
|
The Change From Baseline Levels of S. Hominis A9 Bacteria Abundance, as Measured by Quantitative Polymerase Chain Reaction (qPCR), on Lesional and Non-Lesional Skin Within Each Treatment Group
Day 0 - Non-lesional
|
7027.89 rCFU/cm^2
Interval 3304.917 to 14944.772
|
0.43 rCFU/cm^2
Interval 0.145 to 1.248
|
|
The Change From Baseline Levels of S. Hominis A9 Bacteria Abundance, as Measured by Quantitative Polymerase Chain Reaction (qPCR), on Lesional and Non-Lesional Skin Within Each Treatment Group
Day 4 - Lesional
|
10620.64 rCFU/cm^2
Interval 5022.021 to 22460.681
|
1.43 rCFU/cm^2
Interval 0.488 to 4.182
|
|
The Change From Baseline Levels of S. Hominis A9 Bacteria Abundance, as Measured by Quantitative Polymerase Chain Reaction (qPCR), on Lesional and Non-Lesional Skin Within Each Treatment Group
Day 4 - Non-lesional
|
3761.96 rCFU/cm^2
Interval 1778.861 to 7955.848
|
0.72 rCFU/cm^2
Interval 0.247 to 2.116
|
|
The Change From Baseline Levels of S. Hominis A9 Bacteria Abundance, as Measured by Quantitative Polymerase Chain Reaction (qPCR), on Lesional and Non-Lesional Skin Within Each Treatment Group
Day 7 - Lesional
|
9986.58 rCFU/cm^2
Interval 4722.202 to 21119.759
|
1.46 rCFU/cm^2
Interval 0.5 to 4.286
|
|
The Change From Baseline Levels of S. Hominis A9 Bacteria Abundance, as Measured by Quantitative Polymerase Chain Reaction (qPCR), on Lesional and Non-Lesional Skin Within Each Treatment Group
Day 7 - Non-lesional
|
4807.31 rCFU/cm^2
Interval 2273.159 to 10166.564
|
0.79 rCFU/cm^2
Interval 0.269 to 2.305
|
|
The Change From Baseline Levels of S. Hominis A9 Bacteria Abundance, as Measured by Quantitative Polymerase Chain Reaction (qPCR), on Lesional and Non-Lesional Skin Within Each Treatment Group
Day 8 - Non-lesional
|
875.33 rCFU/cm^2
Interval 411.46 to 1862.155
|
0.62 rCFU/cm^2
Interval 0.205 to 1.896
|
|
The Change From Baseline Levels of S. Hominis A9 Bacteria Abundance, as Measured by Quantitative Polymerase Chain Reaction (qPCR), on Lesional and Non-Lesional Skin Within Each Treatment Group
Day 11 - Lesional
|
33.44 rCFU/cm^2
Interval 15.813 to 70.721
|
2.15 rCFU/cm^2
Interval 0.723 to 6.417
|
|
The Change From Baseline Levels of S. Hominis A9 Bacteria Abundance, as Measured by Quantitative Polymerase Chain Reaction (qPCR), on Lesional and Non-Lesional Skin Within Each Treatment Group
Day 11 - Non-Lesional
|
53.37 rCFU/cm^2
Interval 25.234 to 112.858
|
0.75 rCFU/cm^2
Interval 0.257 to 2.208
|
SECONDARY outcome
Timeframe: Days 0 (1 hour post treatment), 4, 7, 8 and 11Population: Modified Intention-to-Treat (MITT) sample includes all randomized participants who provided skin swabs on Day 0 and Day 7 and administered 75 percent of doses of the study drug.
Amount of S. aureus present on lesional and non-lesional skin measured by Colony Forming Units per centimeter squared (CFU/cm\^2)
Outcome measures
| Measure |
Targeted Microbiome Transplant (TMT)
n=35 Participants
The targeted microbiome transplant (TMT) lotion was provided in single-dose sealed packets.
Participants applied 2 grams of TMT to each ventral aspect of their arm (wrist to upper humerus). Frequency of lotion application: topical application administered twice daily for one week.
|
Placebo Lotion
n=17 Participants
Placebo lotion was provided in single-dose sealed packets.
Participants applied 2 grams of placebo to each ventral aspect of their arm (wrist to upper humerus). Frequency of lotion application: topical application administered twice daily for one week.
|
|---|---|---|
|
The Abundance of S. Aureus, as Measured by Culture, Between Treatment Groups on Lesional and Non-Lesional Skin Separately
Day 0 - Lesional
|
3284.4 CFU/cm^2
Interval 1078.07 to 10006.32
|
1040.5 CFU/cm^2
Interval 221.94 to 4877.72
|
|
The Abundance of S. Aureus, as Measured by Culture, Between Treatment Groups on Lesional and Non-Lesional Skin Separately
Day 0 - Non-lesional
|
271.8 CFU/cm^2
Interval 91.38 to 808.34
|
112.4 CFU/cm^2
Interval 23.14 to 546.1
|
|
The Abundance of S. Aureus, as Measured by Culture, Between Treatment Groups on Lesional and Non-Lesional Skin Separately
Day 4 - Lesional
|
171.9 CFU/cm^2
Interval 56.44 to 523.85
|
2218.9 CFU/cm^2
Interval 473.3 to 10402.22
|
|
The Abundance of S. Aureus, as Measured by Culture, Between Treatment Groups on Lesional and Non-Lesional Skin Separately
Day 4 - Non-lesional
|
66.6 CFU/cm^2
Interval 22.39 to 198.07
|
644.1 CFU/cm^2
Interval 132.57 to 3128.93
|
|
The Abundance of S. Aureus, as Measured by Culture, Between Treatment Groups on Lesional and Non-Lesional Skin Separately
Day 7 - Lesional
|
301.7 CFU/cm^2
Interval 99.04 to 919.29
|
6716.4 CFU/cm^2
Interval 1432.67 to 31487.06
|
|
The Abundance of S. Aureus, as Measured by Culture, Between Treatment Groups on Lesional and Non-Lesional Skin Separately
Day 7 - Non-lesional
|
137.4 CFU/cm^2
Interval 46.21 to 408.78
|
1227.7 CFU/cm^2
Interval 252.71 to 5964.34
|
|
The Abundance of S. Aureus, as Measured by Culture, Between Treatment Groups on Lesional and Non-Lesional Skin Separately
Day 8 - Lesional
|
239.9 CFU/cm^2
Interval 77.9 to 738.56
|
2587.0 CFU/cm^2
Interval 518.99 to 12895.55
|
|
The Abundance of S. Aureus, as Measured by Culture, Between Treatment Groups on Lesional and Non-Lesional Skin Separately
Day 8 - Non-lesional
|
60.3 CFU/cm^2
Interval 20.06 to 181.16
|
649.8 CFU/cm^2
Interval 125.94 to 3352.62
|
|
The Abundance of S. Aureus, as Measured by Culture, Between Treatment Groups on Lesional and Non-Lesional Skin Separately
Day 11 - Lesional
|
81.8 CFU/cm^2
Interval 26.85 to 249.23
|
1856.5 CFU/cm^2
Interval 396.01 to 8703.4
|
|
The Abundance of S. Aureus, as Measured by Culture, Between Treatment Groups on Lesional and Non-Lesional Skin Separately
Day 11 - Non-Lesional
|
49.8 CFU/cm^2
Interval 16.75 to 148.19
|
135.1 CFU/cm^2
Interval 27.81 to 656.26
|
SECONDARY outcome
Timeframe: Days 0 (1 hour post treatment), 4, 7, 8 and 11Population: Modified Intention-to-Treat (MITT) sample includes all randomized participants who provided skin swabs on Day 0 and Day 7 and administered 75 percent of doses of the study drug.
Amount of S. aureus present on lesional and non-lesional skin measured by relative Colony Forming Units per centimeter squared (rCFU/cm\^2)
Outcome measures
| Measure |
Targeted Microbiome Transplant (TMT)
n=35 Participants
The targeted microbiome transplant (TMT) lotion was provided in single-dose sealed packets.
Participants applied 2 grams of TMT to each ventral aspect of their arm (wrist to upper humerus). Frequency of lotion application: topical application administered twice daily for one week.
|
Placebo Lotion
n=17 Participants
Placebo lotion was provided in single-dose sealed packets.
Participants applied 2 grams of placebo to each ventral aspect of their arm (wrist to upper humerus). Frequency of lotion application: topical application administered twice daily for one week.
|
|---|---|---|
|
The Abundance of S. Aureus, as Measured by qPCR (Quantitative Polymerase Chain Reaction), Between Treatment Groups on Lesional and Non-Lesional Skin Separately
Day 0 - Lesional
|
1177.8 rCFU/cm^2
Interval 562.13 to 2467.96
|
788.3 rCFU/cm^2
Interval 275.38 to 2256.52
|
|
The Abundance of S. Aureus, as Measured by qPCR (Quantitative Polymerase Chain Reaction), Between Treatment Groups on Lesional and Non-Lesional Skin Separately
Day 0 - Non-lesional
|
319.8 rCFU/cm^2
Interval 153.29 to 667.35
|
254.6 rCFU/cm^2
Interval 88.61 to 731.38
|
|
The Abundance of S. Aureus, as Measured by qPCR (Quantitative Polymerase Chain Reaction), Between Treatment Groups on Lesional and Non-Lesional Skin Separately
Day 4 - Lesional
|
839.3 rCFU/cm^2
Interval 400.57 to 1758.66
|
950.3 rCFU/cm^2
Interval 331.98 to 2720.26
|
|
The Abundance of S. Aureus, as Measured by qPCR (Quantitative Polymerase Chain Reaction), Between Treatment Groups on Lesional and Non-Lesional Skin Separately
Day 4 - Non-lesional
|
347.3 rCFU/cm^2
Interval 166.47 to 724.75
|
1091.1 rCFU/cm^2
Interval 379.79 to 3134.7
|
|
The Abundance of S. Aureus, as Measured by qPCR (Quantitative Polymerase Chain Reaction), Between Treatment Groups on Lesional and Non-Lesional Skin Separately
Day 7 - Lesional
|
1066.8 rCFU/cm^2
Interval 509.11 to 2235.22
|
2696.7 rCFU/cm^2
Interval 942.05 to 7719.32
|
|
The Abundance of S. Aureus, as Measured by qPCR (Quantitative Polymerase Chain Reaction), Between Treatment Groups on Lesional and Non-Lesional Skin Separately
Day 7 - Non-lesional
|
604.5 rCFU/cm^2
Interval 289.7 to 1261.22
|
745.5 rCFU/cm^2
Interval 259.48 to 2141.71
|
|
The Abundance of S. Aureus, as Measured by qPCR (Quantitative Polymerase Chain Reaction), Between Treatment Groups on Lesional and Non-Lesional Skin Separately
Day 8 - Lesional
|
915.3 rCFU/cm^2
Interval 433.61 to 1931.94
|
2041.9 rCFU/cm^2
Interval 661.92 to 6298.67
|
|
The Abundance of S. Aureus, as Measured by qPCR (Quantitative Polymerase Chain Reaction), Between Treatment Groups on Lesional and Non-Lesional Skin Separately
Day 8 - Non-lesional
|
519.6 rCFU/cm^2
Interval 247.14 to 1092.44
|
423.0 rCFU/cm^2
Interval 140.27 to 1275.86
|
|
The Abundance of S. Aureus, as Measured by qPCR (Quantitative Polymerase Chain Reaction), Between Treatment Groups on Lesional and Non-Lesional Skin Separately
Day 11 - Lesional
|
374.1 rCFU/cm^2
Interval 178.56 to 783.96
|
791.0 rCFU/cm^2
Interval 270.69 to 2311.43
|
|
The Abundance of S. Aureus, as Measured by qPCR (Quantitative Polymerase Chain Reaction), Between Treatment Groups on Lesional and Non-Lesional Skin Separately
Day 11 - Non-Lesional
|
284.4 rCFU/cm^2
Interval 136.31 to 593.45
|
361.4 rCFU/cm^2
Interval 125.79 to 1038.27
|
SECONDARY outcome
Timeframe: Days 0 (1 hour post treatment), 4, 7, 8 and 11Population: Modified Intention-to-Treat (MITT) sample includes all randomized participants who provided skin swabs on Day 0 and Day 7 and administered 75 percent of doses of the study drug.
Amount of S. aureus present on lesional and non-lesional skin measured by Colony Forming Units per centimeter squared (CFU/cm\^2)
Outcome measures
| Measure |
Targeted Microbiome Transplant (TMT)
n=35 Participants
The targeted microbiome transplant (TMT) lotion was provided in single-dose sealed packets.
Participants applied 2 grams of TMT to each ventral aspect of their arm (wrist to upper humerus). Frequency of lotion application: topical application administered twice daily for one week.
|
Placebo Lotion
n=17 Participants
Placebo lotion was provided in single-dose sealed packets.
Participants applied 2 grams of placebo to each ventral aspect of their arm (wrist to upper humerus). Frequency of lotion application: topical application administered twice daily for one week.
|
|---|---|---|
|
The Abundance of S. Aureus, as Measured by Culture, Between Lesional and Non-Lesional Skin Within Each Treatment Group
Day 4 - Non-lesional
|
66.6 CFU/cm^2
Interval 22.39 to 198.07
|
644.1 CFU/cm^2
Interval 132.57 to 3128.93
|
|
The Abundance of S. Aureus, as Measured by Culture, Between Lesional and Non-Lesional Skin Within Each Treatment Group
Day 0 - Lesional
|
3284.4 CFU/cm^2
Interval 1078.07 to 10006.32
|
1040.5 CFU/cm^2
Interval 221.94 to 4877.72
|
|
The Abundance of S. Aureus, as Measured by Culture, Between Lesional and Non-Lesional Skin Within Each Treatment Group
Day 0 - Non-lesional
|
271.8 CFU/cm^2
Interval 91.38 to 808.34
|
112.4 CFU/cm^2
Interval 23.14 to 546.1
|
|
The Abundance of S. Aureus, as Measured by Culture, Between Lesional and Non-Lesional Skin Within Each Treatment Group
Day 4 - Lesional
|
171.9 CFU/cm^2
Interval 56.44 to 523.85
|
2218.9 CFU/cm^2
Interval 473.3 to 10402.22
|
|
The Abundance of S. Aureus, as Measured by Culture, Between Lesional and Non-Lesional Skin Within Each Treatment Group
Day 7 - Lesional
|
301.7 CFU/cm^2
Interval 99.04 to 919.29
|
6716.4 CFU/cm^2
Interval 1432.67 to 31487.06
|
|
The Abundance of S. Aureus, as Measured by Culture, Between Lesional and Non-Lesional Skin Within Each Treatment Group
Day 7 - Non-lesional
|
137.4 CFU/cm^2
Interval 46.21 to 408.78
|
1227.7 CFU/cm^2
Interval 252.71 to 5964.34
|
|
The Abundance of S. Aureus, as Measured by Culture, Between Lesional and Non-Lesional Skin Within Each Treatment Group
Day 8 - Lesional
|
239.9 CFU/cm^2
Interval 77.9 to 738.56
|
2587.0 CFU/cm^2
Interval 518.99 to 12895.55
|
|
The Abundance of S. Aureus, as Measured by Culture, Between Lesional and Non-Lesional Skin Within Each Treatment Group
Day 8 - Non-lesional
|
60.3 CFU/cm^2
Interval 20.06 to 181.16
|
649.8 CFU/cm^2
Interval 125.94 to 3352.62
|
|
The Abundance of S. Aureus, as Measured by Culture, Between Lesional and Non-Lesional Skin Within Each Treatment Group
Day 11 - Lesional
|
81.8 CFU/cm^2
Interval 26.85 to 249.23
|
1856.5 CFU/cm^2
Interval 396.01 to 8703.4
|
|
The Abundance of S. Aureus, as Measured by Culture, Between Lesional and Non-Lesional Skin Within Each Treatment Group
Day 11 - Non-Lesional
|
49.8 CFU/cm^2
Interval 16.75 to 148.19
|
135.1 CFU/cm^2
Interval 27.81 to 656.26
|
SECONDARY outcome
Timeframe: Days 0 (1 hour post treatment), 4, 7, 8 and 11Population: Modified Intention-to-Treat (MITT) sample includes all randomized participants who provided skin swabs on Day 0 and Day 7 and administered 75 percent of doses of the study drug.
Amount of S.aureus present on lesional and non-lesional skin measured by relative Colony Forming Units per centimeter squared (rCFU/cm\^2)
Outcome measures
| Measure |
Targeted Microbiome Transplant (TMT)
n=35 Participants
The targeted microbiome transplant (TMT) lotion was provided in single-dose sealed packets.
Participants applied 2 grams of TMT to each ventral aspect of their arm (wrist to upper humerus). Frequency of lotion application: topical application administered twice daily for one week.
|
Placebo Lotion
n=17 Participants
Placebo lotion was provided in single-dose sealed packets.
Participants applied 2 grams of placebo to each ventral aspect of their arm (wrist to upper humerus). Frequency of lotion application: topical application administered twice daily for one week.
|
|---|---|---|
|
The Abundance of S. Aureus, as Measured by qPCR (Quantitative Polymerase Chain Reaction), Between Lesional and Non-Lesional Skin Within Each Treatment Group
Day 0 - Non-lesional
|
319.8 rCFU/cm^2
Interval 153.29 to 667.35
|
254.6 rCFU/cm^2
Interval 88.61 to 731.38
|
|
The Abundance of S. Aureus, as Measured by qPCR (Quantitative Polymerase Chain Reaction), Between Lesional and Non-Lesional Skin Within Each Treatment Group
Day 0 - Lesional
|
1177.8 rCFU/cm^2
Interval 562.13 to 2467.96
|
788.3 rCFU/cm^2
Interval 275.38 to 2256.52
|
|
The Abundance of S. Aureus, as Measured by qPCR (Quantitative Polymerase Chain Reaction), Between Lesional and Non-Lesional Skin Within Each Treatment Group
Day 4 - Lesional
|
839.3 rCFU/cm^2
Interval 400.57 to 1758.66
|
950.3 rCFU/cm^2
Interval 331.98 to 2720.26
|
|
The Abundance of S. Aureus, as Measured by qPCR (Quantitative Polymerase Chain Reaction), Between Lesional and Non-Lesional Skin Within Each Treatment Group
Day 4 - Non-lesional
|
347.3 rCFU/cm^2
Interval 166.47 to 724.75
|
1091.1 rCFU/cm^2
Interval 379.79 to 3134.7
|
|
The Abundance of S. Aureus, as Measured by qPCR (Quantitative Polymerase Chain Reaction), Between Lesional and Non-Lesional Skin Within Each Treatment Group
Day 7 - Lesional
|
1066.8 rCFU/cm^2
Interval 509.11 to 2235.22
|
2696.7 rCFU/cm^2
Interval 942.05 to 7719.32
|
|
The Abundance of S. Aureus, as Measured by qPCR (Quantitative Polymerase Chain Reaction), Between Lesional and Non-Lesional Skin Within Each Treatment Group
Day 7 - Non-lesional
|
604.5 rCFU/cm^2
Interval 289.7 to 1261.22
|
745.5 rCFU/cm^2
Interval 259.48 to 2141.71
|
|
The Abundance of S. Aureus, as Measured by qPCR (Quantitative Polymerase Chain Reaction), Between Lesional and Non-Lesional Skin Within Each Treatment Group
Day 8 - Lesional
|
915.3 rCFU/cm^2
Interval 433.61 to 1931.94
|
2041.9 rCFU/cm^2
Interval 661.92 to 6298.67
|
|
The Abundance of S. Aureus, as Measured by qPCR (Quantitative Polymerase Chain Reaction), Between Lesional and Non-Lesional Skin Within Each Treatment Group
Day 8 - Non-lesional
|
519.6 rCFU/cm^2
Interval 247.14 to 1092.44
|
423.0 rCFU/cm^2
Interval 140.27 to 1275.86
|
|
The Abundance of S. Aureus, as Measured by qPCR (Quantitative Polymerase Chain Reaction), Between Lesional and Non-Lesional Skin Within Each Treatment Group
Day 11 - Lesional
|
374.1 rCFU/cm^2
Interval 178.56 to 783.96
|
791.0 rCFU/cm^2
Interval 270.69 to 2311.43
|
|
The Abundance of S. Aureus, as Measured by qPCR (Quantitative Polymerase Chain Reaction), Between Lesional and Non-Lesional Skin Within Each Treatment Group
Day 11 - Non-Lesional
|
284.4 rCFU/cm^2
Interval 136.31 to 593.45
|
361.4 rCFU/cm^2
Interval 125.79 to 1038.27
|
SECONDARY outcome
Timeframe: Days 0 (1 hour post treatment), 4, 7, 8 and 11Population: Modified Intention-to-Treat (MITT) sample includes all randomized participants who provided skin swabs on Day 0 and Day 7 and administered 75 percent of doses of the study drug.
Amount of S. aureus present on lesional and non-lesional skin measured by Colony Forming Units per centimeter squared (CFU/cm\^2)
Outcome measures
| Measure |
Targeted Microbiome Transplant (TMT)
n=35 Participants
The targeted microbiome transplant (TMT) lotion was provided in single-dose sealed packets.
Participants applied 2 grams of TMT to each ventral aspect of their arm (wrist to upper humerus). Frequency of lotion application: topical application administered twice daily for one week.
|
Placebo Lotion
n=17 Participants
Placebo lotion was provided in single-dose sealed packets.
Participants applied 2 grams of placebo to each ventral aspect of their arm (wrist to upper humerus). Frequency of lotion application: topical application administered twice daily for one week.
|
|---|---|---|
|
The Change From Baseline Levels of S. Aureus Abundance, as Measured by Culture, Between Lesional and Non-Lesional Skin Within Each Treatment Group
Day 0 - Lesional
|
0.12 CFU/cm^2
Interval 0.039 to 0.38
|
0.44 CFU/cm^2
Interval 0.085 to 2.248
|
|
The Change From Baseline Levels of S. Aureus Abundance, as Measured by Culture, Between Lesional and Non-Lesional Skin Within Each Treatment Group
Day 0 - Non-lesional
|
0.69 CFU/cm^2
Interval 0.221 to 2.161
|
1.45 CFU/cm^2
Interval 0.282 to 7.442
|
|
The Change From Baseline Levels of S. Aureus Abundance, as Measured by Culture, Between Lesional and Non-Lesional Skin Within Each Treatment Group
Day 4 - Lesional
|
0.05 CFU/cm^2
Interval 0.017 to 0.164
|
2.13 CFU/cm^2
Interval 0.415 to 10.964
|
|
The Change From Baseline Levels of S. Aureus Abundance, as Measured by Culture, Between Lesional and Non-Lesional Skin Within Each Treatment Group
Day 4 - Non-lesional
|
0.25 CFU/cm^2
Interval 0.078 to 0.767
|
5.73 CFU/cm^2
Interval 1.114 to 29.455
|
|
The Change From Baseline Levels of S. Aureus Abundance, as Measured by Culture, Between Lesional and Non-Lesional Skin Within Each Treatment Group
Day 7 - Lesional
|
0.09 CFU/cm^2
Interval 0.029 to 0.288
|
6.46 CFU/cm^2
Interval 1.256 to 33.186
|
|
The Change From Baseline Levels of S. Aureus Abundance, as Measured by Culture, Between Lesional and Non-Lesional Skin Within Each Treatment Group
Day 7 - Non-lesional
|
0.51 CFU/cm^2
Interval 0.162 to 1.583
|
10.92 CFU/cm^2
Interval 2.124 to 56.147
|
|
The Change From Baseline Levels of S. Aureus Abundance, as Measured by Culture, Between Lesional and Non-Lesional Skin Within Each Treatment Group
Day 8 - Lesional
|
0.07 CFU/cm^2
Interval 0.023 to 0.231
|
2.49 CFU/cm^2
Interval 0.456 to 13.546
|
|
The Change From Baseline Levels of S. Aureus Abundance, as Measured by Culture, Between Lesional and Non-Lesional Skin Within Each Treatment Group
Day 8 - Non-lesional
|
0.22 CFU/cm^2
Interval 0.07 to 0.7
|
5.78 CFU/cm^2
Interval 1.061 to 31.493
|
|
The Change From Baseline Levels of S. Aureus Abundance, as Measured by Culture, Between Lesional and Non-Lesional Skin Within Each Treatment Group
Day 11 - Lesional
|
0.02 CFU/cm^2
Interval 0.008 to 0.078
|
1.78 CFU/cm^2
Interval 0.347 to 9.173
|
|
The Change From Baseline Levels of S. Aureus Abundance, as Measured by Culture, Between Lesional and Non-Lesional Skin Within Each Treatment Group
Day 11 - Non-Lesional
|
0.18 CFU/cm^2
Interval 0.059 to 0.574
|
1.20 CFU/cm^2
Interval 0.234 to 6.178
|
SECONDARY outcome
Timeframe: Days 0 (1 hour post treatment), 4, 7, 8 and 11Population: Modified Intention-to-Treat (MITT) sample includes all randomized participants who provided skin swabs on Day 0 and Day 7 and administered 75 percent of doses of the study drug.
Amount of S. aureus present on lesional and non-lesional skin measured by relative Colony Forming Units per centimeter squared (rCFU/cm\^2)
Outcome measures
| Measure |
Targeted Microbiome Transplant (TMT)
n=35 Participants
The targeted microbiome transplant (TMT) lotion was provided in single-dose sealed packets.
Participants applied 2 grams of TMT to each ventral aspect of their arm (wrist to upper humerus). Frequency of lotion application: topical application administered twice daily for one week.
|
Placebo Lotion
n=17 Participants
Placebo lotion was provided in single-dose sealed packets.
Participants applied 2 grams of placebo to each ventral aspect of their arm (wrist to upper humerus). Frequency of lotion application: topical application administered twice daily for one week.
|
|---|---|---|
|
The Change From Baseline Levels of S. Aureus Abundance, as Measured by qPCR (Quantitative Polymerase Chain Reaction), Between Lesional and Non-Lesional Skin Within Each Treatment Group
Day 8 - Non-lesional
|
1.62 rCFU/cm^2
Interval 0.707 to 3.735
|
1.66 rCFU/cm^2
Interval 0.487 to 5.671
|
|
The Change From Baseline Levels of S. Aureus Abundance, as Measured by qPCR (Quantitative Polymerase Chain Reaction), Between Lesional and Non-Lesional Skin Within Each Treatment Group
Day 0 - Lesional
|
0.72 rCFU/cm^2
Interval 0.314 to 1.637
|
0.55 rCFU/cm^2
Interval 0.17 to 1.814
|
|
The Change From Baseline Levels of S. Aureus Abundance, as Measured by qPCR (Quantitative Polymerase Chain Reaction), Between Lesional and Non-Lesional Skin Within Each Treatment Group
Day 0 - Non-lesional
|
2.89 rCFU/cm^2
Interval 1.258 to 6.646
|
1.11 rCFU/cm^2
Interval 0.341 to 3.645
|
|
The Change From Baseline Levels of S. Aureus Abundance, as Measured by qPCR (Quantitative Polymerase Chain Reaction), Between Lesional and Non-Lesional Skin Within Each Treatment Group
Day 4 - Lesional
|
0.71 rCFU/cm^2
Interval 0.312 to 1.628
|
1.21 rCFU/cm^2
Interval 0.369 to 3.943
|
|
The Change From Baseline Levels of S. Aureus Abundance, as Measured by qPCR (Quantitative Polymerase Chain Reaction), Between Lesional and Non-Lesional Skin Within Each Treatment Group
Day 4 - Non-lesional
|
1.09 rCFU/cm^2
Interval 0.475 to 2.48
|
4.29 rCFU/cm^2
Interval 1.31 to 14.02
|
|
The Change From Baseline Levels of S. Aureus Abundance, as Measured by qPCR (Quantitative Polymerase Chain Reaction), Between Lesional and Non-Lesional Skin Within Each Treatment Group
Day 7 - Lesional
|
0.91 rCFU/cm^2
Interval 0.397 to 2.069
|
3.42 rCFU/cm^2
Interval 1.046 to 11.19
|
|
The Change From Baseline Levels of S. Aureus Abundance, as Measured by qPCR (Quantitative Polymerase Chain Reaction), Between Lesional and Non-Lesional Skin Within Each Treatment Group
Day 7 - Non-lesional
|
1.89 rCFU/cm^2
Interval 0.827 to 4.317
|
2.93 rCFU/cm^2
Interval 0.895 to 9.579
|
|
The Change From Baseline Levels of S. Aureus Abundance, as Measured by qPCR (Quantitative Polymerase Chain Reaction), Between Lesional and Non-Lesional Skin Within Each Treatment Group
Day 8 - Lesional
|
0.78 rCFU/cm^2
Interval 0.338 to 1.787
|
2.59 rCFU/cm^2
Interval 0.741 to 9.051
|
|
The Change From Baseline Levels of S. Aureus Abundance, as Measured by qPCR (Quantitative Polymerase Chain Reaction), Between Lesional and Non-Lesional Skin Within Each Treatment Group
Day 11 - Lesional
|
0.32 rCFU/cm^2
Interval 0.139 to 0.726
|
1.00 rCFU/cm^2
Interval 0.301 to 3.346
|
|
The Change From Baseline Levels of S. Aureus Abundance, as Measured by qPCR (Quantitative Polymerase Chain Reaction), Between Lesional and Non-Lesional Skin Within Each Treatment Group
Day 11 - Non-Lesional
|
0.89 rCFU/cm^2
Interval 0.389 to 2.031
|
1.42 rCFU/cm^2
Interval 0.434 to 4.644
|
SECONDARY outcome
Timeframe: Days 0 (1 hour post treatment), 4, 7, 8 and 11Population: Modified Intention-to-Treat (MITT) sample includes all randomized participants who provided skin swabs on Day 0 and Day 7 and administered 75 percent of doses of the study drug.
Amount of combined S. hominis present on lesional and non-lesional skin measured by relative Colony Forming Units per centimeter squared (rCFU/cm\^2)
Outcome measures
| Measure |
Targeted Microbiome Transplant (TMT)
n=35 Participants
The targeted microbiome transplant (TMT) lotion was provided in single-dose sealed packets.
Participants applied 2 grams of TMT to each ventral aspect of their arm (wrist to upper humerus). Frequency of lotion application: topical application administered twice daily for one week.
|
Placebo Lotion
n=17 Participants
Placebo lotion was provided in single-dose sealed packets.
Participants applied 2 grams of placebo to each ventral aspect of their arm (wrist to upper humerus). Frequency of lotion application: topical application administered twice daily for one week.
|
|---|---|---|
|
The Abundance of Bacterial Deoxyribonucleic Acid (DNA) of Combined S. Hominis, as Measured by Quantitative Polymerase Chain Reaction (qPCR), Between Treatment Groups on Lesional and Non-Lesional Skin Separately
Day 0 (post-treatment) - Lesional
|
103291.5 rCFU/cm^2
Interval 64503.91 to 165387.54
|
86.3 rCFU/cm^2
Interval 43.92 to 169.52
|
|
The Abundance of Bacterial Deoxyribonucleic Acid (DNA) of Combined S. Hominis, as Measured by Quantitative Polymerase Chain Reaction (qPCR), Between Treatment Groups on Lesional and Non-Lesional Skin Separately
Day 0 (post-treatment) - Non-lesional
|
82176.8 rCFU/cm^2
Interval 50998.8 to 132415.39
|
108.5 rCFU/cm^2
Interval 55.21 to 213.23
|
|
The Abundance of Bacterial Deoxyribonucleic Acid (DNA) of Combined S. Hominis, as Measured by Quantitative Polymerase Chain Reaction (qPCR), Between Treatment Groups on Lesional and Non-Lesional Skin Separately
Day 4 - Lesional
|
97810.2 rCFU/cm^2
Interval 61086.59 to 156610.99
|
125.5 rCFU/cm^2
Interval 63.89 to 246.61
|
|
The Abundance of Bacterial Deoxyribonucleic Acid (DNA) of Combined S. Hominis, as Measured by Quantitative Polymerase Chain Reaction (qPCR), Between Treatment Groups on Lesional and Non-Lesional Skin Separately
Day 4 - Non-lesional
|
40682.3 rCFU/cm^2
Interval 25406.91 to 65141.85
|
203.7 rCFU/cm^2
Interval 103.65 to 400.33
|
|
The Abundance of Bacterial Deoxyribonucleic Acid (DNA) of Combined S. Hominis, as Measured by Quantitative Polymerase Chain Reaction (qPCR), Between Treatment Groups on Lesional and Non-Lesional Skin Separately
Day 7 - Lesional
|
98401.7 rCFU/cm^2
Interval 61456.0 to 157558.06
|
146.1 rCFU/cm^2
Interval 74.36 to 287.03
|
|
The Abundance of Bacterial Deoxyribonucleic Acid (DNA) of Combined S. Hominis, as Measured by Quantitative Polymerase Chain Reaction (qPCR), Between Treatment Groups on Lesional and Non-Lesional Skin Separately
Day 7 - Non-lesional
|
46775.4 rCFU/cm^2
Interval 29212.14 to 74898.23
|
92.0 rCFU/cm^2
Interval 46.81 to 180.79
|
|
The Abundance of Bacterial Deoxyribonucleic Acid (DNA) of Combined S. Hominis, as Measured by Quantitative Polymerase Chain Reaction (qPCR), Between Treatment Groups on Lesional and Non-Lesional Skin Separately
Day 8 - Lesional
|
6068.6 rCFU/cm^2
Interval 3765.7 to 97793.98
|
100.9 rCFU/cm^2
Interval 48.16 to 211.61
|
|
The Abundance of Bacterial Deoxyribonucleic Acid (DNA) of Combined S. Hominis, as Measured by Quantitative Polymerase Chain Reaction (qPCR), Between Treatment Groups on Lesional and Non-Lesional Skin Separately
Day 8 - Non-lesional
|
9675.2 rCFU/cm^2
Interval 6003.6 to 15592.22
|
89.7 rCFU/cm^2
Interval 43.79 to 183.75
|
|
The Abundance of Bacterial Deoxyribonucleic Acid (DNA) of Combined S. Hominis, as Measured by Quantitative Polymerase Chain Reaction (qPCR), Between Treatment Groups on Lesional and Non-Lesional Skin Separately
Day 11 - Lesional
|
743.8 rCFU/cm^2
Interval 464.54 to 1190.97
|
196.4 rCFU/cm^2
Interval 98.05 to 393.42
|
|
The Abundance of Bacterial Deoxyribonucleic Acid (DNA) of Combined S. Hominis, as Measured by Quantitative Polymerase Chain Reaction (qPCR), Between Treatment Groups on Lesional and Non-Lesional Skin Separately
Day 11 - Non-Lesional
|
1081.7 rCFU/cm^2
Interval 675.56 to 1732.08
|
67.2 rCFU/cm^2
Interval 34.22 to 132.16
|
SECONDARY outcome
Timeframe: Days 0 (1 hour post treatment), 4, 7, 8 and 11Population: Modified Intention-to-Treat (MITT) sample includes all randomized participants who provided skin swabs on Day 0 and Day 7 and administered 75 percent of doses of the study drug.
Amount of combined Staphylococci present on lesional and non-lesional skin measured by relative Colony Forming Units per centimeter squared (rCFU/cm\^2)
Outcome measures
| Measure |
Targeted Microbiome Transplant (TMT)
n=35 Participants
The targeted microbiome transplant (TMT) lotion was provided in single-dose sealed packets.
Participants applied 2 grams of TMT to each ventral aspect of their arm (wrist to upper humerus). Frequency of lotion application: topical application administered twice daily for one week.
|
Placebo Lotion
n=17 Participants
Placebo lotion was provided in single-dose sealed packets.
Participants applied 2 grams of placebo to each ventral aspect of their arm (wrist to upper humerus). Frequency of lotion application: topical application administered twice daily for one week.
|
|---|---|---|
|
The Abundance of Bacterial Deoxyribonucleic Acid (DNA) of Combined Staphylococci, as Measured by qPCR (Quantitative Polymerase Chain Reaction), Between Treatment Groups on Lesional and Non-Lesional Skin Separately
Day 0 (post-treatment) - Lesional
|
169474.3 rCFU/cm^2
Interval 101234.39 to 283713.19
|
1186.0 rCFU/cm^2
Interval 569.89 to 2468.35
|
|
The Abundance of Bacterial Deoxyribonucleic Acid (DNA) of Combined Staphylococci, as Measured by qPCR (Quantitative Polymerase Chain Reaction), Between Treatment Groups on Lesional and Non-Lesional Skin Separately
Day 0 (post-treatment) - Non-lesional
|
201324.3 rCFU/cm^2
Interval 119927.33 to 337966.84
|
754.4 rCFU/cm^2
Interval 361.3 to 1575.17
|
|
The Abundance of Bacterial Deoxyribonucleic Acid (DNA) of Combined Staphylococci, as Measured by qPCR (Quantitative Polymerase Chain Reaction), Between Treatment Groups on Lesional and Non-Lesional Skin Separately
Day 4 - Lesional
|
144236.8 rCFU/cm^2
Interval 86158.92 to 241463.63
|
4099.1 rCFU/cm^2
Interval 1969.61 to 8530.96
|
|
The Abundance of Bacterial Deoxyribonucleic Acid (DNA) of Combined Staphylococci, as Measured by qPCR (Quantitative Polymerase Chain Reaction), Between Treatment Groups on Lesional and Non-Lesional Skin Separately
Day 4 - Non-lesional
|
111784.4 rCFU/cm^2
Interval 67001.83 to 186498.58
|
2188.7 rCFU/cm^2
Interval 1048.21 to 4569.94
|
|
The Abundance of Bacterial Deoxyribonucleic Acid (DNA) of Combined Staphylococci, as Measured by qPCR (Quantitative Polymerase Chain Reaction), Between Treatment Groups on Lesional and Non-Lesional Skin Separately
Day 7 - Lesional
|
171843.8 rCFU/cm^2
Interval 102649.79 to 287679.9
|
4126.8 rCFU/cm^2
Interval 1982.93 to 8588.65
|
|
The Abundance of Bacterial Deoxyribonucleic Acid (DNA) of Combined Staphylococci, as Measured by qPCR (Quantitative Polymerase Chain Reaction), Between Treatment Groups on Lesional and Non-Lesional Skin Separately
Day 7 - Non-lesional
|
101610.2 rCFU/cm^2
Interval 60903.58 to 169524.19
|
1355.5 rCFU/cm^2
Interval 649.17 to 2830.24
|
|
The Abundance of Bacterial Deoxyribonucleic Acid (DNA) of Combined Staphylococci, as Measured by qPCR (Quantitative Polymerase Chain Reaction), Between Treatment Groups on Lesional and Non-Lesional Skin Separately
Day 8 - Lesional
|
15115.6 rCFU/cm^2
Interval 8972.04 to 25466.03
|
4190.4 rCFU/cm^2
Interval 1885.57 to 9312.5
|
|
The Abundance of Bacterial Deoxyribonucleic Acid (DNA) of Combined Staphylococci, as Measured by qPCR (Quantitative Polymerase Chain Reaction), Between Treatment Groups on Lesional and Non-Lesional Skin Separately
Day 8 - Non-lesional
|
23330.8 rCFU/cm^2
Interval 13891.98 to 39182.93
|
895.4 rCFU/cm^2
Interval 410.93 to 1950.87
|
|
The Abundance of Bacterial Deoxyribonucleic Acid (DNA) of Combined Staphylococci, as Measured by qPCR (Quantitative Polymerase Chain Reaction), Between Treatment Groups on Lesional and Non-Lesional Skin Separately
Day 11 - Lesional
|
2874.3 rCFU/cm^2
Interval 1716.97 to 4811.87
|
2063.5 rCFU/cm^2
Interval 973.77 to 4372.86
|
|
The Abundance of Bacterial Deoxyribonucleic Acid (DNA) of Combined Staphylococci, as Measured by qPCR (Quantitative Polymerase Chain Reaction), Between Treatment Groups on Lesional and Non-Lesional Skin Separately
Day 11 - Non-Lesional
|
3135.3 rCFU/cm^2
Interval 1879.25 to 5230.87
|
918.6 rCFU/cm^2
Interval 439.96 to 1918.12
|
SECONDARY outcome
Timeframe: Days 0 (1 hour post treatment), 4, 7, 8 and 11Population: Modified Intention-to-Treat (MITT) sample includes all randomized participants who provided skin swabs on Day 0 and Day 7 and administered 75 percent of doses of the study drug.
Amount of combined bacteria present on lesional and non-lesional skin measured by relative Colony Forming Units per centimeter squared (rCFU/cm\^2)
Outcome measures
| Measure |
Targeted Microbiome Transplant (TMT)
n=35 Participants
The targeted microbiome transplant (TMT) lotion was provided in single-dose sealed packets.
Participants applied 2 grams of TMT to each ventral aspect of their arm (wrist to upper humerus). Frequency of lotion application: topical application administered twice daily for one week.
|
Placebo Lotion
n=17 Participants
Placebo lotion was provided in single-dose sealed packets.
Participants applied 2 grams of placebo to each ventral aspect of their arm (wrist to upper humerus). Frequency of lotion application: topical application administered twice daily for one week.
|
|---|---|---|
|
The Abundance of Combined Bacterial Deoxyribonucleic Acid (DNA), as Measured by qPCR (Quantitative Polymerase Chain Reaction), Between Treatment Groups on Lesional and Non-Lesional Skin Separately
Day 0 (post-treatment) - Lesional
|
42609.4 rCFU/cm^2
Interval 26067.18 to 69649.16
|
833.8 rCFU/cm^2
Interval 412.72 to 1684.66
|
|
The Abundance of Combined Bacterial Deoxyribonucleic Acid (DNA), as Measured by qPCR (Quantitative Polymerase Chain Reaction), Between Treatment Groups on Lesional and Non-Lesional Skin Separately
Day 0 (post-treatment) - Non-lesional
|
45142.5 rCFU/cm^2
Interval 27483.01 to 74149.34
|
812.9 rCFU/cm^2
Interval 401.98 to 1643.95
|
|
The Abundance of Combined Bacterial Deoxyribonucleic Acid (DNA), as Measured by qPCR (Quantitative Polymerase Chain Reaction), Between Treatment Groups on Lesional and Non-Lesional Skin Separately
Day 4 - Lesional
|
37621.5 rCFU/cm^2
Interval 23015.76 to 61496.03
|
2923.3 rCFU/cm^2
Interval 1446.93 to 5906.17
|
|
The Abundance of Combined Bacterial Deoxyribonucleic Acid (DNA), as Measured by qPCR (Quantitative Polymerase Chain Reaction), Between Treatment Groups on Lesional and Non-Lesional Skin Separately
Day 4 - Non-lesional
|
19461.7 rCFU/cm^2
Interval 11918.85 to 31777.91
|
1652.0 rCFU/cm^2
Interval 816.9 to 3340.83
|
|
The Abundance of Combined Bacterial Deoxyribonucleic Acid (DNA), as Measured by qPCR (Quantitative Polymerase Chain Reaction), Between Treatment Groups on Lesional and Non-Lesional Skin Separately
Day 7 - Lesional
|
37338.7 rCFU/cm^2
Interval 22842.73 to 61033.73
|
3259.5 rCFU/cm^2
Interval 1613.31 to 6585.3
|
|
The Abundance of Combined Bacterial Deoxyribonucleic Acid (DNA), as Measured by qPCR (Quantitative Polymerase Chain Reaction), Between Treatment Groups on Lesional and Non-Lesional Skin Separately
Day 7 - Non-lesional
|
25114.3 rCFU/cm^2
Interval 15380.71 to 41007.86
|
1084.1 rCFU/cm^2
Interval 536.08 to 2192.36
|
|
The Abundance of Combined Bacterial Deoxyribonucleic Acid (DNA), as Measured by qPCR (Quantitative Polymerase Chain Reaction), Between Treatment Groups on Lesional and Non-Lesional Skin Separately
Day 8 - Lesional
|
5072.8 rCFU/cm^2
Interval 3083.69 to 8345.12
|
2097.8 rCFU/cm^2
Interval 974.26 to 4517.19
|
|
The Abundance of Combined Bacterial Deoxyribonucleic Acid (DNA), as Measured by qPCR (Quantitative Polymerase Chain Reaction), Between Treatment Groups on Lesional and Non-Lesional Skin Separately
Day 8 - Non-lesional
|
6323.9 rCFU/cm^2
Interval 3848.09 to 10392.63
|
572.1 rCFU/cm^2
Interval 271.26 to 1206.67
|
|
The Abundance of Combined Bacterial Deoxyribonucleic Acid (DNA), as Measured by qPCR (Quantitative Polymerase Chain Reaction), Between Treatment Groups on Lesional and Non-Lesional Skin Separately
Day 11 - Lesional
|
1204.9 rCFU/cm^2
Interval 737.15 to 1969.6
|
1596.9 rCFU/cm^2
Interval 776.65 to 3283.46
|
|
The Abundance of Combined Bacterial Deoxyribonucleic Acid (DNA), as Measured by qPCR (Quantitative Polymerase Chain Reaction), Between Treatment Groups on Lesional and Non-Lesional Skin Separately
Day 11 - Non-Lesional
|
1666.8 rCFU/cm^2
Interval 1020.81 to 2721.67
|
686.1 rCFU/cm^2
Interval 339.26 to 1387.44
|
Adverse Events
Targeted Microbiome Transplant (TMT)
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Placebo Lotion
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Targeted Microbiome Transplant (TMT)
n=36 participants at risk
The targeted microbiome transplant (TMT) lotion was provided in single-dose sealed packets.
Participants applied 2 grams of TMT to each ventral aspect of their arm (wrist to upper humerus). Frequency of lotion application: topical application administered twice daily for one week.
|
Placebo Lotion
n=18 participants at risk
Placebo lotion was provided in single-dose sealed packets.
Participants applied 2 grams of placebo to each ventral aspect of their arm (wrist to upper humerus). Frequency of lotion application: topical application administered twice daily for one week.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.8%
1/36 • Number of events 1 • 8 days
Adverse Events (AEs) grade 1 or higher. Graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03
|
5.6%
1/18 • Number of events 1 • 8 days
Adverse Events (AEs) grade 1 or higher. Graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03
|
|
General disorders
Peripheral swelling
|
22.2%
8/36 • Number of events 14 • 8 days
Adverse Events (AEs) grade 1 or higher. Graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03
|
22.2%
4/18 • Number of events 11 • 8 days
Adverse Events (AEs) grade 1 or higher. Graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03
|
|
Infections and infestations
Hordeolum
|
0.00%
0/36 • 8 days
Adverse Events (AEs) grade 1 or higher. Graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03
|
5.6%
1/18 • Number of events 1 • 8 days
Adverse Events (AEs) grade 1 or higher. Graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
33.3%
12/36 • Number of events 21 • 8 days
Adverse Events (AEs) grade 1 or higher. Graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03
|
38.9%
7/18 • Number of events 18 • 8 days
Adverse Events (AEs) grade 1 or higher. Graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/36 • 8 days
Adverse Events (AEs) grade 1 or higher. Graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03
|
5.6%
1/18 • Number of events 1 • 8 days
Adverse Events (AEs) grade 1 or higher. Graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/36 • 8 days
Adverse Events (AEs) grade 1 or higher. Graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03
|
5.6%
1/18 • Number of events 1 • 8 days
Adverse Events (AEs) grade 1 or higher. Graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
11.1%
4/36 • Number of events 6 • 8 days
Adverse Events (AEs) grade 1 or higher. Graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03
|
0.00%
0/18 • 8 days
Adverse Events (AEs) grade 1 or higher. Graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03
|
|
Skin and subcutaneous tissue disorders
Eczema
|
41.7%
15/36 • Number of events 28 • 8 days
Adverse Events (AEs) grade 1 or higher. Graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03
|
61.1%
11/18 • Number of events 25 • 8 days
Adverse Events (AEs) grade 1 or higher. Graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/36 • 8 days
Adverse Events (AEs) grade 1 or higher. Graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03
|
5.6%
1/18 • Number of events 2 • 8 days
Adverse Events (AEs) grade 1 or higher. Graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03
|
Additional Information
Director, Clinical Research Operations Program
DAIT/NIAID
Phone: 301-594-7669
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place