Trial Outcomes & Findings for Use of Jet-injection in Photodynamic Therapy for Basal Cell Carcinoma (NCT NCT04552990)

Last Updated: 2026-06-18

Results Overview

Clinical evaluation of local skin responses will be performed at Day 0 (PDT treatment #1). The LSR/Local Skin Responses Grading Scale is an objective tool allowing practicing dermatologists to characterize and compare LSRs to existing and, potentially, future therapies. Characteristics of skin responses are identified and allocated a numeric grade of severity (0-4, with 4 being the highest grade of severity).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

16 participants

Primary outcome timeframe

Baseline (Day 0)

Results posted on

2026-06-18

Participant Flow

Participant milestones

Participant milestones
Measure	Tumor Excision, No Illumination The first four patients will not receive illumination but have their tumors excised after jet-injection (AirGent2.0) of ALA (Levulan Kerastick), and 3h incubation; this will be done to assess biodistribution of ALA through fluorescence microscopy.	PDT Treatment With Jet-injections Patient 5-16 will receive PDT treatment with jet-injections of ALA followed by 3h incubation under occlusion and thereafter illumination with red light (total dose 75 J/cm2). In patient 5-16, the PDT treatment will be repeated after 2 weeks.
Overall Study STARTED	4	12
Overall Study COMPLETED	4	11
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Tumor Excision, No Illumination The first four patients will not receive illumination but have their tumors excised after jet-injection (AirGent2.0) of ALA (Levulan Kerastick), and 3h incubation; this will be done to assess biodistribution of ALA through fluorescence microscopy.	PDT Treatment With Jet-injections Patient 5-16 will receive PDT treatment with jet-injections of ALA followed by 3h incubation under occlusion and thereafter illumination with red light (total dose 75 J/cm2). In patient 5-16, the PDT treatment will be repeated after 2 weeks.
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

Use of Jet-injection in Photodynamic Therapy for Basal Cell Carcinoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tumor Excision, No Illumination n=4 Participants The first four patients will not receive illumination but have their tumors excised after jet-injection (AirGent2.0) of ALA (Levulan Kerastick), and 3h incubation; this will be done to assess biodistribution of ALA through fluorescence microscopy.	PDT Treatment With Jet-injections n=12 Participants Patient 5-16 will receive PDT treatment with jet-injections of ALA followed by 3h incubation under occlusion and thereafter illumination with red light (total dose 75 J/cm2). In patient 5-16, the PDT treatment will be repeated after 2 weeks.	Total n=16 Participants Total of all reporting groups
Age, Continuous	61.25 years n=20 Participants	64.5 years n=20 Participants	63.7 years n=40 Participants
Sex: Female, Male Female	0 Participants n=20 Participants	6 Participants n=20 Participants	6 Participants n=40 Participants
Sex: Female, Male Male	4 Participants n=20 Participants	6 Participants n=20 Participants	10 Participants n=40 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=20 Participants	12 Participants n=20 Participants	16 Participants n=40 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Race (NIH/OMB) Asian	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Race (NIH/OMB) Black or African American	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Race (NIH/OMB) White	4 Participants n=20 Participants	12 Participants n=20 Participants	16 Participants n=40 Participants
Race (NIH/OMB) More than one race	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Region of Enrollment United States	4 Participants n=20 Participants	12 Participants n=20 Participants	16 Participants n=40 Participants

PRIMARY outcome

Timeframe: Baseline (Day 0)

Population: PDT treatment arm only due to participants receiving Illumination as part of treatment regimen. The Tumor Excision, No Illumination cohort's purpose was only to assess biodistribution of ALA through fluorescence microscopy.

Outcome measures

Outcome measures
Measure	Tumor Excision, No Illumination The first four patients will not receive illumination but have their tumors excised after jet-injection (AirGent2.0) of ALA (Levulan Kerastick), and 3h incubation; this will be done to assess biodistribution of ALA through fluorescence microscopy. Jet injection of ALA: The Basal Cell Carcinoma/BCC tumor and a 5 mm margin will be injected with a grid of 80 microliters of 20% ALA at 5-8.5 mm between each injection (30-50% overlap). Surgical excision: In the first 4 patients, the tumor will be excised according to national guidelines after 3h incubation (+/- 30 min is accepted). Incubation: After injection of ALA, the tumor will be occluded with a light proof dressing and incubated for 3h (+/- 30 min).	PDT Treatment With Jet-injections n=12 Participants Patient 5-16 will receive PDT treatment with jet-injections of ALA followed by 3h incubation under occlusion and thereafter illumination with red light (total dose 75 J/cm2). In patient 5-16, the PDT treatment will be repeated after 2 weeks. Jet injection of ALA: The Basal Cell Carcinoma/BCC tumor and a 5 mm margin will be injected with a grid of 80 microliters of 20% ALA at 5-8.5 mm between each injection (30-50% overlap). Surgical excision: In the first 4 patients, the tumor will be excised according to national guidelines after 3h incubation (+/- 30 min is accepted). Illumination: For patients 5-16,after 3h incubation (+/- 30 min), the tumor will be illuminated with red light corresponding to a dose of 75 J/cm2 570- 670 nm or equivalent dose of narrowband red light. The intervention will be repeated at after 14 days in patient 5-16. If the wound is not healed at two weeks, the treatment may be postponed to allow healing (patient 5-16). Incubation: After injection of ALA, the tumor will be occluded with a light proof dressing and incubated for 3h (+/- 30 min).
Clinical Evaluation of Local Skin Responses on Day 0 Edema	—	1 score on a scale Interval 0.0 to 1.0
Clinical Evaluation of Local Skin Responses on Day 0 Erythema	—	2 score on a scale Interval 0.0 to 2.0
Clinical Evaluation of Local Skin Responses on Day 0 Flaking	—	0 score on a scale Interval 0.0 to 1.0
Clinical Evaluation of Local Skin Responses on Day 0 Crusting	—	0 score on a scale Interval 0.0 to 1.0
Clinical Evaluation of Local Skin Responses on Day 0 Pustulation	—	1 score on a scale Interval 0.0 to 1.0
Clinical Evaluation of Local Skin Responses on Day 0 Erosion/Ulceration	—	1 score on a scale Interval 0.0 to 1.0

PRIMARY outcome

Timeframe: Day 3

Clinical evaluation of local skin responses will be performed at Day 3. The LSR/Local Skin Responses Grading Scale is an objective tool allowing practicing dermatologists to characterize and compare LSRs to existing and, potentially, future therapies. Characteristics of skin responses are identified and allocated a numeric grade of severity (0-4, with 4 being the highest grade of severity).

Outcome measures

Outcome measures
Measure	Tumor Excision, No Illumination The first four patients will not receive illumination but have their tumors excised after jet-injection (AirGent2.0) of ALA (Levulan Kerastick), and 3h incubation; this will be done to assess biodistribution of ALA through fluorescence microscopy. Jet injection of ALA: The Basal Cell Carcinoma/BCC tumor and a 5 mm margin will be injected with a grid of 80 microliters of 20% ALA at 5-8.5 mm between each injection (30-50% overlap). Surgical excision: In the first 4 patients, the tumor will be excised according to national guidelines after 3h incubation (+/- 30 min is accepted). Incubation: After injection of ALA, the tumor will be occluded with a light proof dressing and incubated for 3h (+/- 30 min).	PDT Treatment With Jet-injections n=12 Participants Patient 5-16 will receive PDT treatment with jet-injections of ALA followed by 3h incubation under occlusion and thereafter illumination with red light (total dose 75 J/cm2). In patient 5-16, the PDT treatment will be repeated after 2 weeks. Jet injection of ALA: The Basal Cell Carcinoma/BCC tumor and a 5 mm margin will be injected with a grid of 80 microliters of 20% ALA at 5-8.5 mm between each injection (30-50% overlap). Surgical excision: In the first 4 patients, the tumor will be excised according to national guidelines after 3h incubation (+/- 30 min is accepted). Illumination: For patients 5-16,after 3h incubation (+/- 30 min), the tumor will be illuminated with red light corresponding to a dose of 75 J/cm2 570- 670 nm or equivalent dose of narrowband red light. The intervention will be repeated at after 14 days in patient 5-16. If the wound is not healed at two weeks, the treatment may be postponed to allow healing (patient 5-16). Incubation: After injection of ALA, the tumor will be occluded with a light proof dressing and incubated for 3h (+/- 30 min).
Clinical Evaluation of Local Skin Responses on Day 3 Erythema	—	2 score on a scale Interval 1.0 to 2.0
Clinical Evaluation of Local Skin Responses on Day 3 Edema	—	1 score on a scale Interval 0.0 to 1.0
Clinical Evaluation of Local Skin Responses on Day 3 Flaking	—	1 score on a scale Interval 1.0 to 1.0
Clinical Evaluation of Local Skin Responses on Day 3 Crusting	—	1 score on a scale Interval 1.0 to 1.0
Clinical Evaluation of Local Skin Responses on Day 3 Pustulation	—	0 score on a scale Interval 0.0 to 0.0
Clinical Evaluation of Local Skin Responses on Day 3 Erosion/Ulceration	—	0 score on a scale Interval 0.0 to 1.0

PRIMARY outcome

Timeframe: Day 14

Clinical evaluation of local skin responses will be performed at Day 14 (PDT treatment #2). The LSR/Local Skin Responses Grading Scale is an objective tool allowing practicing dermatologists to characterize and compare LSRs to existing and, potentially, future therapies. Characteristics of skin responses are identified and allocated a numeric grade of severity (0-4, with 4 being the highest grade of severity).

Outcome measures

Outcome measures
Measure	Tumor Excision, No Illumination The first four patients will not receive illumination but have their tumors excised after jet-injection (AirGent2.0) of ALA (Levulan Kerastick), and 3h incubation; this will be done to assess biodistribution of ALA through fluorescence microscopy. Jet injection of ALA: The Basal Cell Carcinoma/BCC tumor and a 5 mm margin will be injected with a grid of 80 microliters of 20% ALA at 5-8.5 mm between each injection (30-50% overlap). Surgical excision: In the first 4 patients, the tumor will be excised according to national guidelines after 3h incubation (+/- 30 min is accepted). Incubation: After injection of ALA, the tumor will be occluded with a light proof dressing and incubated for 3h (+/- 30 min).	PDT Treatment With Jet-injections n=12 Participants Patient 5-16 will receive PDT treatment with jet-injections of ALA followed by 3h incubation under occlusion and thereafter illumination with red light (total dose 75 J/cm2). In patient 5-16, the PDT treatment will be repeated after 2 weeks. Jet injection of ALA: The Basal Cell Carcinoma/BCC tumor and a 5 mm margin will be injected with a grid of 80 microliters of 20% ALA at 5-8.5 mm between each injection (30-50% overlap). Surgical excision: In the first 4 patients, the tumor will be excised according to national guidelines after 3h incubation (+/- 30 min is accepted). Illumination: For patients 5-16,after 3h incubation (+/- 30 min), the tumor will be illuminated with red light corresponding to a dose of 75 J/cm2 570- 670 nm or equivalent dose of narrowband red light. The intervention will be repeated at after 14 days in patient 5-16. If the wound is not healed at two weeks, the treatment may be postponed to allow healing (patient 5-16). Incubation: After injection of ALA, the tumor will be occluded with a light proof dressing and incubated for 3h (+/- 30 min).
Clinical Evaluation of Local Skin Responses on Day 14 Erythema	—	2 score on a scale Interval 1.0 to 2.0
Clinical Evaluation of Local Skin Responses on Day 14 Edema	—	1 score on a scale Interval 0.0 to 1.0
Clinical Evaluation of Local Skin Responses on Day 14 Flaking	—	0 score on a scale Interval 0.0 to 1.0
Clinical Evaluation of Local Skin Responses on Day 14 Crusting	—	1 score on a scale Interval 0.0 to 1.0
Clinical Evaluation of Local Skin Responses on Day 14 Pustulation	—	0 score on a scale Interval 0.0 to 0.0
Clinical Evaluation of Local Skin Responses on Day 14 Erosion/Ulceration	—	0 score on a scale Interval 0.0 to 0.0

PRIMARY outcome

Timeframe: Day 17

Clinical evaluation of local skin responses will be performed at Day 17. The LSR/Local Skin Responses Grading Scale is an objective tool allowing practicing dermatologists to characterize and compare LSRs to existing and, potentially, future therapies. Characteristics of skin responses are identified and allocated a numeric grade of severity (0-4, with 4 being the highest grade of severity).

Outcome measures

Outcome measures
Measure	Tumor Excision, No Illumination The first four patients will not receive illumination but have their tumors excised after jet-injection (AirGent2.0) of ALA (Levulan Kerastick), and 3h incubation; this will be done to assess biodistribution of ALA through fluorescence microscopy. Jet injection of ALA: The Basal Cell Carcinoma/BCC tumor and a 5 mm margin will be injected with a grid of 80 microliters of 20% ALA at 5-8.5 mm between each injection (30-50% overlap). Surgical excision: In the first 4 patients, the tumor will be excised according to national guidelines after 3h incubation (+/- 30 min is accepted). Incubation: After injection of ALA, the tumor will be occluded with a light proof dressing and incubated for 3h (+/- 30 min).	PDT Treatment With Jet-injections n=12 Participants Patient 5-16 will receive PDT treatment with jet-injections of ALA followed by 3h incubation under occlusion and thereafter illumination with red light (total dose 75 J/cm2). In patient 5-16, the PDT treatment will be repeated after 2 weeks. Jet injection of ALA: The Basal Cell Carcinoma/BCC tumor and a 5 mm margin will be injected with a grid of 80 microliters of 20% ALA at 5-8.5 mm between each injection (30-50% overlap). Surgical excision: In the first 4 patients, the tumor will be excised according to national guidelines after 3h incubation (+/- 30 min is accepted). Illumination: For patients 5-16,after 3h incubation (+/- 30 min), the tumor will be illuminated with red light corresponding to a dose of 75 J/cm2 570- 670 nm or equivalent dose of narrowband red light. The intervention will be repeated at after 14 days in patient 5-16. If the wound is not healed at two weeks, the treatment may be postponed to allow healing (patient 5-16). Incubation: After injection of ALA, the tumor will be occluded with a light proof dressing and incubated for 3h (+/- 30 min).
Clinical Evaluation of Local Skin Responses on Day 17 Erythema	—	2 score on a scale Interval 1.0 to 2.0
Clinical Evaluation of Local Skin Responses on Day 17 Edema	—	1 score on a scale Interval 0.0 to 1.0
Clinical Evaluation of Local Skin Responses on Day 17 Flaking	—	1 score on a scale Interval 0.0 to 1.0
Clinical Evaluation of Local Skin Responses on Day 17 Crusting	—	0 score on a scale Interval 0.0 to 1.0
Clinical Evaluation of Local Skin Responses on Day 17 Pustulation	—	0 score on a scale Interval 0.0 to 1.0
Clinical Evaluation of Local Skin Responses on Day 17 Erosion/Ulceration	—	0 score on a scale Interval 0.0 to 0.0

PRIMARY outcome

Timeframe: 3 months after treatment

Clinical evaluation of local skin responses will be performed 3 months post treatment. The LSR/Local Skin Responses Grading Scale is an objective tool allowing practicing dermatologists to characterize and compare LSRs to existing and, potentially, future therapies. Characteristics of skin responses are identified and allocated a numeric grade of severity (0-4, with 4 being the highest grade of severity).

Outcome measures

Outcome measures
Measure	Tumor Excision, No Illumination The first four patients will not receive illumination but have their tumors excised after jet-injection (AirGent2.0) of ALA (Levulan Kerastick), and 3h incubation; this will be done to assess biodistribution of ALA through fluorescence microscopy. Jet injection of ALA: The Basal Cell Carcinoma/BCC tumor and a 5 mm margin will be injected with a grid of 80 microliters of 20% ALA at 5-8.5 mm between each injection (30-50% overlap). Surgical excision: In the first 4 patients, the tumor will be excised according to national guidelines after 3h incubation (+/- 30 min is accepted). Incubation: After injection of ALA, the tumor will be occluded with a light proof dressing and incubated for 3h (+/- 30 min).	PDT Treatment With Jet-injections n=12 Participants Patient 5-16 will receive PDT treatment with jet-injections of ALA followed by 3h incubation under occlusion and thereafter illumination with red light (total dose 75 J/cm2). In patient 5-16, the PDT treatment will be repeated after 2 weeks. Jet injection of ALA: The Basal Cell Carcinoma/BCC tumor and a 5 mm margin will be injected with a grid of 80 microliters of 20% ALA at 5-8.5 mm between each injection (30-50% overlap). Surgical excision: In the first 4 patients, the tumor will be excised according to national guidelines after 3h incubation (+/- 30 min is accepted). Illumination: For patients 5-16,after 3h incubation (+/- 30 min), the tumor will be illuminated with red light corresponding to a dose of 75 J/cm2 570- 670 nm or equivalent dose of narrowband red light. The intervention will be repeated at after 14 days in patient 5-16. If the wound is not healed at two weeks, the treatment may be postponed to allow healing (patient 5-16). Incubation: After injection of ALA, the tumor will be occluded with a light proof dressing and incubated for 3h (+/- 30 min).
Clinical Evaluation of Local Skin Responses 3 Months Post Treatment Erythema	—	0.5 score on a scale Interval 0.0 to 1.0
Clinical Evaluation of Local Skin Responses 3 Months Post Treatment Edema	—	0 score on a scale Interval 0.0 to 0.0
Clinical Evaluation of Local Skin Responses 3 Months Post Treatment Flaking	—	0 score on a scale Interval 0.0 to 0.0
Clinical Evaluation of Local Skin Responses 3 Months Post Treatment Crusting	—	0 score on a scale Interval 0.0 to 0.0
Clinical Evaluation of Local Skin Responses 3 Months Post Treatment Pustulation	—	0 score on a scale Interval 0.0 to 0.0
Clinical Evaluation of Local Skin Responses 3 Months Post Treatment Erosion/Ulceration	—	0 score on a scale Interval 0.0 to 0.0

Adverse Events

Tumor Excision, No Illumination

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

PDT Treatment With Jet-injections

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Tumor Excision, No Illumination n=4 participants at risk The first four patients will not receive illumination but have their tumors excised after jet-injection (AirGent2.0) of ALA (Levulan Kerastick), and 3h incubation; this will be done to assess biodistribution of ALA through fluorescence microscopy. Jet injection of ALA: The Basal Cell Carcinoma/BCC tumor and a 5 mm margin will be injected with a grid of 80 microliters of 20% ALA at 5-8.5 mm between each injection (30-50% overlap). Surgical excision: In the first 4 patients, the tumor will be excised according to national guidelines after 3h incubation (+/- 30 min is accepted). Incubation: After injection of ALA, the tumor will be occluded with a light proof dressing and incubated for 3h (+/- 30 min).	PDT Treatment With Jet-injections n=12 participants at risk Patient 5-16 will receive PDT treatment with jet-injections of ALA followed by 3h incubation under occlusion and thereafter illumination with red light (total dose 75 J/cm2). In patient 5-16, the PDT treatment will be repeated after 2 weeks. Jet injection of ALA: The Basal Cell Carcinoma/BCC tumor and a 5 mm margin will be injected with a grid of 80 microliters of 20% ALA at 5-8.5 mm between each injection (30-50% overlap). Surgical excision: In the first 4 patients, the tumor will be excised according to national guidelines after 3h incubation (+/- 30 min is accepted). Illumination: For patients 5-16,after 3h incubation (+/- 30 min), the tumor will be illuminated with red light corresponding to a dose of 75 J/cm2 570- 670 nm or equivalent dose of narrowband red light. The intervention will be repeated at after 14 days in patient 5-16. If the wound is not healed at two weeks, the treatment may be postponed to allow healing (patient 5-16). Incubation: After injection of ALA, the tumor will be occluded with a light proof dressing and incubated for 3h (+/- 30 min).
Infections and infestations Infections and infestations - Other, specify	0.00% 0/4 • 3 months	8.3% 1/12 • 3 months

Other adverse events

Other adverse events
Measure	Tumor Excision, No Illumination n=4 participants at risk The first four patients will not receive illumination but have their tumors excised after jet-injection (AirGent2.0) of ALA (Levulan Kerastick), and 3h incubation; this will be done to assess biodistribution of ALA through fluorescence microscopy. Jet injection of ALA: The Basal Cell Carcinoma/BCC tumor and a 5 mm margin will be injected with a grid of 80 microliters of 20% ALA at 5-8.5 mm between each injection (30-50% overlap). Surgical excision: In the first 4 patients, the tumor will be excised according to national guidelines after 3h incubation (+/- 30 min is accepted). Incubation: After injection of ALA, the tumor will be occluded with a light proof dressing and incubated for 3h (+/- 30 min).	PDT Treatment With Jet-injections n=12 participants at risk Patient 5-16 will receive PDT treatment with jet-injections of ALA followed by 3h incubation under occlusion and thereafter illumination with red light (total dose 75 J/cm2). In patient 5-16, the PDT treatment will be repeated after 2 weeks. Jet injection of ALA: The Basal Cell Carcinoma/BCC tumor and a 5 mm margin will be injected with a grid of 80 microliters of 20% ALA at 5-8.5 mm between each injection (30-50% overlap). Surgical excision: In the first 4 patients, the tumor will be excised according to national guidelines after 3h incubation (+/- 30 min is accepted). Illumination: For patients 5-16,after 3h incubation (+/- 30 min), the tumor will be illuminated with red light corresponding to a dose of 75 J/cm2 570- 670 nm or equivalent dose of narrowband red light. The intervention will be repeated at after 14 days in patient 5-16. If the wound is not healed at two weeks, the treatment may be postponed to allow healing (patient 5-16). Incubation: After injection of ALA, the tumor will be occluded with a light proof dressing and incubated for 3h (+/- 30 min).
Infections and infestations Cellulitis	0.00% 0/4 • 3 months	8.3% 1/12 • 3 months

Additional Information

Dr. Anthony Rossi, MD

Memorial Sloan Kettering Cancer Center

Phone: 646-608-3982

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place