Trial Outcomes & Findings for Effect of Photodynamic Treatment on Skin Microbiome. Single Center Study (NCT NCT04067843)

NCT ID: NCT04067843

Last Updated: 2022-05-18

Results Overview

Skin swabs were taken before photodynamic treatment, after photodynamic treatment and after antisepsis for evaluation of bacterial growth on agar plates

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 20 participants
• Primary outcome timeframe: Day 1
• Results posted on: 2022-05-18

Participant Flow

Participant milestones

Measure	Photodynamic Treatment Skin microbiome after photodynamic treatment before and after skin antisepsis Photodynamic treatment: Photosensitiser application, followed by fluorescence photography, Photodynamic therapy (PDT) (1x) over 15 minutes	Control Group Skin microbiome before and after skin antisepsis, no photodynamic treatment
Overall Study STARTED	10	10
Overall Study COMPLETED	10	10
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Photodynamic Treatment n=10 Participants Skin microbiome analysis after photodynamic treatment before and after skin antisepsis	Control Group n=10 Participants No photodynamic treatment: Skin microbiome before and after skin antisepsis without photodynamic treatment	Total n=20 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=10 Participants	10 Participants n=10 Participants	20 Participants n=20 Participants
Age, Categorical >=65 years	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants
Sex: Female, Male Female	5 Participants n=10 Participants	7 Participants n=10 Participants	12 Participants n=20 Participants
Sex: Female, Male Male	5 Participants n=10 Participants	3 Participants n=10 Participants	8 Participants n=20 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Switzerland	10 Participants n=10 Participants	10 Participants n=10 Participants	20 Participants n=20 Participants

PRIMARY outcome

Timeframe: Day 1

Skin swabs were taken before photodynamic treatment, after photodynamic treatment and after antisepsis for evaluation of bacterial growth on agar plates

Outcome measures

Measure	Photodynamic Treatment n=10 Participants Skin swabs were taken before photodynamic treatment as baseline, after photodynamic treatment and after skin antisepsis to analyse the skin microbiome Photodynamic treatment: Photosensitiser application, followed by fluorescence photography, Photodynamic therapy (PDT) (1x) over 15 minutes	Control Group n=10 Participants Skin swabs were taken before and after skin antisepsis
Number of Participants With Bacterial Growth Before and After Photodynamic Treatment and After Skin Antisepsis Bacterial growth at baseline	10 Participants	10 Participants
Number of Participants With Bacterial Growth Before and After Photodynamic Treatment and After Skin Antisepsis Bacterial growth after PDT	3 Participants	NA Participants in the control group, skin swabs were only taken before and after antisepsis. PDT was not performed
Number of Participants With Bacterial Growth Before and After Photodynamic Treatment and After Skin Antisepsis Bacterial growth after antisepsis	0 Participants	5 Participants

PRIMARY outcome

Timeframe: Day 21±3 after PDT treatment

Population: was only performed in the photodynamic treatment arm (n=10) and not in the control group

Skin swabs were taken 21 days after photodynamic treatment before and after skin antisepsis to evaluate bacterial growth on agar plates

Outcome measures

Measure	Photodynamic Treatment n=10 Participants Skin swabs were taken before photodynamic treatment as baseline, after photodynamic treatment and after skin antisepsis to analyse the skin microbiome Photodynamic treatment: Photosensitiser application, followed by fluorescence photography, Photodynamic therapy (PDT) (1x) over 15 minutes	Control Group Skin swabs were taken before and after skin antisepsis
Number of Participants With Bacterial Growth 3 Weeks After Photodynamic Treatment Bacterial growth before antisepsis	10 Participants	—
Number of Participants With Bacterial Growth 3 Weeks After Photodynamic Treatment Bacterial growth after antisepsis	6 Participants	—

SECONDARY outcome

Timeframe: Day 1 and Day 21

Population: Phylogenetic Comparisons of Isolated Bacteria was not performed due to clear results in aim 1 and 2.

was not performed due to clear results in aim 1 and 2.

Outcome measures

Outcome data not reported

Adverse Events

Photodynamic Treatment

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

Dr. Yvonne Achermann

University Hospital Zurich

Phone: +41442553402

Email: yvonne.achermann@usz.ch

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place