Trial Outcomes & Findings for Pilot Study of PDL to Treat BCC and SCCIS (NCT NCT01245972)

Results Overview

Review of the pathology report showing whether there was residual tumor or not. If there was no residual tumor in the pathology report from the confirmatory excision, the laser treatment was considered successful (tumor clearance).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

23 participants

Primary outcome timeframe

21 to 36 days after the treatment

Results posted on

2019-09-16

Participant Flow

Participant milestones

Participant milestones
Measure	Control No treatment administered	PDL Setting 1 PDL Setting 1: 15 J/cm2, 3ms pulse length, no dynamic cooling, 7mm spot size, 10% overlap between the pulses, 2 passes PDL Treatment: Pulsed-dye laser (PDL) treatment at one of two settings.	PDL Setting 2 PDL Setting 2: 7.5 J/cm2, 3ms pulse length, no dynamic cooling, 10mm spot size, 10% overlap between the pulses, 2 stacked pulses PDL Treatment: Pulsed-dye laser (PDL) treatment at one of two settings.
Overall Study STARTED	7	8	8
Overall Study COMPLETED	7	8	8
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control n=7 Participants No treatment administered	PDL Setting 1 n=8 Participants PDL Setting 1: 15 J/cm2, 3ms pulse length, no dynamic cooling, 7mm spot size, 10% overlap between the pulses, 2 passes PDL Treatment: Pulsed-dye laser (PDL) treatment at one of two settings.	PDL Setting 2 n=8 Participants PDL Setting 2: 7.5 J/cm2, 3ms pulse length, no dynamic cooling, 10mm spot size, 10% overlap between the pulses, 2 stacked pulses PDL Treatment: Pulsed-dye laser (PDL) treatment at one of two settings.	Total n=23 Participants Total of all reporting groups
Age, Continuous	67 years STANDARD_DEVIATION 12 • n=7 Participants	66 years STANDARD_DEVIATION 12 • n=8 Participants	56 years STANDARD_DEVIATION 12 • n=8 Participants	62 years STANDARD_DEVIATION 12 • n=23 Participants
Sex: Female, Male Female	3 Participants n=7 Participants	4 Participants n=8 Participants	4 Participants n=8 Participants	11 Participants n=23 Participants
Sex: Female, Male Male	4 Participants n=7 Participants	4 Participants n=8 Participants	4 Participants n=8 Participants	12 Participants n=23 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 21 to 36 days after the treatment

Review of the pathology report showing whether there was residual tumor or not. If there was no residual tumor in the pathology report from the confirmatory excision, the laser treatment was considered successful (tumor clearance).

Outcome measures

Outcome measures
Measure	Control n=7 Participants No treatment administered	PDL Setting 1 n=8 Participants PDL Setting 1: 15 J/cm2, 3ms pulse length, no dynamic cooling, 7mm spot size, 10% overlap between the pulses, 2 passes PDL Treatment: Pulsed-dye laser (PDL) treatment at one of two settings.	PDL Setting 2 n=8 Participants PDL Setting 2: 7.5 J/cm2, 3ms pulse length, no dynamic cooling, 10mm spot size, 10% overlap between the pulses, 2 stacked pulses PDL Treatment: Pulsed-dye laser (PDL) treatment at one of two settings.
Tumor Clearance	2 Participants	2 Participants	5 Participants

Adverse Events

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

PDL Setting 1

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

PDL Setting 2

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Control n=7 participants at risk No treatment administered	PDL Setting 1 n=8 participants at risk PDL Setting 1: 15 J/cm2, 3ms pulse length, no dynamic cooling, 7mm spot size, 10% overlap between the pulses, 2 passes PDL Treatment: Pulsed-dye laser (PDL) treatment at one of two settings.	PDL Setting 2 n=8 participants at risk PDL Setting 2: 7.5 J/cm2, 3ms pulse length, no dynamic cooling, 10mm spot size, 10% overlap between the pulses, 2 stacked pulses PDL Treatment: Pulsed-dye laser (PDL) treatment at one of two settings.
Skin and subcutaneous tissue disorders erythema	0.00% 0/7	50.0% 4/8 • Number of events 4	75.0% 6/8 • Number of events 6

Additional Information

S. Brian Jiang

ucsdmed

Phone: 8586571663

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place