Trial Outcomes & Findings for Effect of Photodynamic Therapy on Skin Microbiome. Single Center Study (PHOMIC-II) (NCT NCT04618276)
NCT ID: NCT04618276
Last Updated: 2024-10-15
Results Overview
Quantitative evaluation of bacterial density and species from skin swabs taken before PDT, immeadiately after PDT, and after after skin antisepsis using culture technique
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
Day 0 after PDT
Results posted on
2024-10-15
Participant Flow
Each study participant was a control participant as well (procedure on the contralateral leg without intervention)
Unit of analysis: PDT: right side, no PDT left side
Participant milestones
| Measure |
Arm A (MAL Group)
1. Skin swab for culture in the groin for baseline
2. PDT with 5% topical methyl aminolevulinate (MAL) as the prodrug for the photosensitizer Pp IX
3. Skin swab for culture
4. Skin antisepsis
5. Skin swab for culture
Photodynamic Therapy: PDT with two different photosensitizers
|
Arm B (Methylene Blue Group)
1. Skin swab for culture in the groin for baseline
2. PDT with 0.01% methylene blue based photosensitizer (NF-031)
3. Skin swab for culture
4. Skin antisepsis
5. Skin swab for culture
Photodynamic Therapy: PDT with two different photosensitizers
|
|---|---|---|
|
Overall Study
STARTED
|
10 20
|
10 20
|
|
Overall Study
COMPLETED
|
10 20
|
10 20
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Photodynamic Therapy on Skin Microbiome. Single Center Study (PHOMIC-II)
Baseline characteristics by cohort
| Measure |
Arm A (MAL Group)
n=10 Participants
1. Skin swab for culture in the groin for baseline
2. PDT with 5% topical methyl aminolevulinate (MAL) as the prodrug for the photosensitizer Pp IX
3. Skin swab for culture
4. Skin antisepsis
5. Skin swab for culture
Photodynamic Therapy: PDT with two different photosensitizers
|
Arm B (Methylene Blue Group)
n=10 Participants
1. Skin swab for culture in the groin for baseline
2. PDT with 0.01% methylene blue based photosensitizer (NF-031)
3. Skin swab for culture
4. Skin antisepsis
5. Skin swab for culture
Photodynamic Therapy: PDT with two different photosensitizers
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
27.5 years
n=5 Participants
|
32 years
n=7 Participants
|
30 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Switzerland
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
40 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 0 after PDTPopulation: Number of patients with no growth of bacteria on the skin
Quantitative evaluation of bacterial density and species from skin swabs taken before PDT, immeadiately after PDT, and after after skin antisepsis using culture technique
Outcome measures
| Measure |
Arm A (MAL Group)
n=10 Participants
1. Skin swab for culture in the groin for baseline
2. PDT with 5% topical methyl aminolevulinate (MAL) as the prodrug for the photosensitizer Pp IX
3. Skin swab for culture
4. Skin antisepsis
5. Skin swab for culture
Photodynamic Therapy: PDT with two different photosensitizers
|
Arm B (Methylene Blue Group)
n=10 Participants
1. Skin swab for culture in the groin for baseline
2. PDT with 0.01% methylene blue based photosensitizer (NF-031)
3. Skin swab for culture
4. Skin antisepsis
5. Skin swab for culture
Photodynamic Therapy: PDT with two different photosensitizers
|
|---|---|---|
|
Number of Patients With no Growth of Bacteria on the Skin
PDT group right side
|
3 Participants
|
7 Participants
|
|
Number of Patients With no Growth of Bacteria on the Skin
Control side without PDT
|
6 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: Day 1 after PDTQuantitative evaluatuation of bacterial density and species from skin swabs taken 1 day after PDT before and after skin antisepsis
Outcome measures
| Measure |
Arm A (MAL Group)
n=10 Participants
1. Skin swab for culture in the groin for baseline
2. PDT with 5% topical methyl aminolevulinate (MAL) as the prodrug for the photosensitizer Pp IX
3. Skin swab for culture
4. Skin antisepsis
5. Skin swab for culture
Photodynamic Therapy: PDT with two different photosensitizers
|
Arm B (Methylene Blue Group)
n=10 Participants
1. Skin swab for culture in the groin for baseline
2. PDT with 0.01% methylene blue based photosensitizer (NF-031)
3. Skin swab for culture
4. Skin antisepsis
5. Skin swab for culture
Photodynamic Therapy: PDT with two different photosensitizers
|
|---|---|---|
|
Number of Patients With no Growth of Bacteria on the Skin on After 1 Day
|
2 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: Day 3 after PDTQuantitative evaluatuation of bacterial density and species from skin swabs taken 3 days after PDT before and after skin antisepsis
Outcome measures
| Measure |
Arm A (MAL Group)
n=10 Participants
1. Skin swab for culture in the groin for baseline
2. PDT with 5% topical methyl aminolevulinate (MAL) as the prodrug for the photosensitizer Pp IX
3. Skin swab for culture
4. Skin antisepsis
5. Skin swab for culture
Photodynamic Therapy: PDT with two different photosensitizers
|
Arm B (Methylene Blue Group)
n=10 Participants
1. Skin swab for culture in the groin for baseline
2. PDT with 0.01% methylene blue based photosensitizer (NF-031)
3. Skin swab for culture
4. Skin antisepsis
5. Skin swab for culture
Photodynamic Therapy: PDT with two different photosensitizers
|
|---|---|---|
|
Number of Patients With no Growth of Bacteria on the Skin After 3 Days
|
3 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: Day 5Population: Day 5 was for most of the patients on the weekend which was not feasible to take swabs. Therefore we skipped day 5
Quantitative evaluatuation of bacterial density and species from skin ...
Outcome measures
Outcome data not reported
Adverse Events
Arm A (MAL Group)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm B (Methylene Blue 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
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
PD Dr. med. Yvonne Achermann
University Hospital Zurich
Phone: +41 44 396 74 18
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place