Trial Outcomes & Findings for Randomized Pilot Study of Treatment for BCC Using the Multiplex 595/1064 nm Laser (NCT NCT02270645)
NCT ID: NCT02270645
Last Updated: 2018-10-02
Results Overview
Number of lesions cleared clinically and histologically. The lesion clearance was determined by measuring the size of lesion which also included a histological evaluation 4 weeks after the treatment.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
12 participants
Primary outcome timeframe
91 days
Results posted on
2018-10-02
Participant Flow
Unit of analysis: Lesion
Participant milestones
| Measure |
Treatment: 595/1064 Multiplex Laser
Subjects in the treatment arm will receive 3 treatments using the 595/1064 multiplex laser spaced by a four week interval (+/- 3 days), administered in an outpatient clinic setting. If a subject in the treatment arm has multiple BCCs satisfying inclusion criteria, all BCCs will be treated.
Four weeks (+/- 3 days) after the last treatment (Day 84) both treatment and control patients will be assessed for final clinical appearance, measurement, and evaluation of the lesion by a dermatologist.
Subjects will also undergo deep excisional biopsy encompassing the entire lesion to determine residual tumor cell presence. If histologic examination of the tissue reveals residual BCC, then the subject will receive standard of treatment.
595/1064 multiplex laser: 595/1064 multiplex laser will be used 3 times spaced by a four week interval (+/- 3 days), it will be administered in an outpatient clinic setting.
|
Control
Subjects in the control arm will receive 3 regular study visits spaced 4 weeks (+/- 3 days) apart. If a subject in the control arm has multiple BCCs satisfying inclusion criteria, all BCCs will not be treated.
Four weeks (+/- 3 days) after the last (Day 84) both treatment and control patients will be assessed for final clinical appearance, measurement, and evaluation of the lesion by a dermatologist.
Subjects will also undergo deep excisional biopsy encompassing the entire lesion to determine residual tumor cell presence. If histologic examination of the tissue reveals residual BCC, then the subject will receive standard of treatment.
|
|---|---|---|
|
Overall Study
STARTED
|
8 11
|
4 5
|
|
Overall Study
COMPLETED
|
6 9
|
4 5
|
|
Overall Study
NOT COMPLETED
|
2 2
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Randomized Pilot Study of Treatment for BCC Using the Multiplex 595/1064 nm Laser
Baseline characteristics by cohort
| Measure |
Treatment: 595/1064 Multiplex Laser
n=8 Participants
Subjects in the treatment arm will receive 3 treatments using the 595/1064 multiplex laser spaced by a four week interval (+/- 3 days), administered in an outpatient clinic setting. If a subject in the treatment arm has multiple BCCs satisfying inclusion criteria, all BCCs will be treated.
Four weeks (+/- 3 days) after the last treatment (Day 84) both treatment and control patients will be assessed for final clinical appearance, measurement, and evaluation of the lesion by a dermatologist.
Subjects will also undergo deep excisional biopsy encompassing the entire lesion to determine residual tumor cell presence. If histologic examination of the tissue reveals residual BCC, then the subject will receive standard of treatment.
595/1064 multiplex laser: 595/1064 multiplex laser will be used 3 times spaced by a four week interval (+/- 3 days), it will be administered in an outpatient clinic setting.
|
Control
n=4 Participants
Subjects in the control arm will receive 3 regular study visits spaced 4 weeks (+/- 3 days) apart. If a subject in the control arm has multiple BCCs satisfying inclusion criteria, all BCCs will not be treated.
Four weeks (+/- 3 days) after the last (Day 84) both treatment and control patients will be assessed for final clinical appearance, measurement, and evaluation of the lesion by a dermatologist.
Subjects will also undergo deep excisional biopsy encompassing the entire lesion to determine residual tumor cell presence. If histologic examination of the tissue reveals residual BCC, then the subject will receive standard of treatment.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Age, Continuous
|
57.7 years
n=99 Participants
|
63.5 years
n=107 Participants
|
59.6 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 91 daysPopulation: In the treatment arm, there were 6 patients with a total of 9 lesions. Some of these patients had multiple lesions treated. In the control arm, there were 4 patients with a total of 5 lesions. Some of these patients had multiple lesions treated.
Number of lesions cleared clinically and histologically. The lesion clearance was determined by measuring the size of lesion which also included a histological evaluation 4 weeks after the treatment.
Outcome measures
| Measure |
Treatment: 595/1064 Multiplex Laser
n=9 Lesion
Subjects in the treatment arm will receive 3 treatments using the 595/1064 multiplex laser spaced by a four week interval (+/- 3 days), administered in an outpatient clinic setting. If a subject in the treatment arm has multiple BCCs satisfying inclusion criteria, all BCCs will be treated.
Four weeks (+/- 3 days) after the last treatment (Day 84) both treatment and control patients will be assessed for final clinical appearance, measurement, and evaluation of the lesion by a dermatologist.
Subjects will also undergo deep excisional biopsy encompassing the entire lesion to determine residual tumor cell presence. If histologic examination of the tissue reveals residual BCC, then the subject will receive standard of treatment.
595/1064 multiplex laser: 595/1064 multiplex laser will be used 3 times spaced by a four week interval (+/- 3 days), it will be administered in an outpatient clinic setting.
|
Control
n=5 Lesion
Subjects in the control arm will receive 3 regular study visits spaced 4 weeks (+/- 3 days) apart. If a subject in the control arm has multiple BCCs satisfying inclusion criteria, all BCCs will not be treated.
Four weeks (+/- 3 days) after the last (Day 84) both treatment and control patients will be assessed for final clinical appearance, measurement, and evaluation of the lesion by a dermatologist.
Subjects will also undergo deep excisional biopsy encompassing the entire lesion to determine residual tumor cell presence. If histologic examination of the tissue reveals residual BCC, then the subject will receive standard of treatment.
|
|---|---|---|
|
Percentage of Lesions Cleared Histologically
|
3 Lesion
|
5 Lesion
|
SECONDARY outcome
Timeframe: 91 daysAdverse events reported by participants
Outcome measures
| Measure |
Treatment: 595/1064 Multiplex Laser
n=8 Participants
Subjects in the treatment arm will receive 3 treatments using the 595/1064 multiplex laser spaced by a four week interval (+/- 3 days), administered in an outpatient clinic setting. If a subject in the treatment arm has multiple BCCs satisfying inclusion criteria, all BCCs will be treated.
Four weeks (+/- 3 days) after the last treatment (Day 84) both treatment and control patients will be assessed for final clinical appearance, measurement, and evaluation of the lesion by a dermatologist.
Subjects will also undergo deep excisional biopsy encompassing the entire lesion to determine residual tumor cell presence. If histologic examination of the tissue reveals residual BCC, then the subject will receive standard of treatment.
595/1064 multiplex laser: 595/1064 multiplex laser will be used 3 times spaced by a four week interval (+/- 3 days), it will be administered in an outpatient clinic setting.
|
Control
n=4 Participants
Subjects in the control arm will receive 3 regular study visits spaced 4 weeks (+/- 3 days) apart. If a subject in the control arm has multiple BCCs satisfying inclusion criteria, all BCCs will not be treated.
Four weeks (+/- 3 days) after the last (Day 84) both treatment and control patients will be assessed for final clinical appearance, measurement, and evaluation of the lesion by a dermatologist.
Subjects will also undergo deep excisional biopsy encompassing the entire lesion to determine residual tumor cell presence. If histologic examination of the tissue reveals residual BCC, then the subject will receive standard of treatment.
|
|---|---|---|
|
Number of Adverse Events Reported
|
1 Adverse Events
|
0 Adverse Events
|
Adverse Events
Treatment: 595/1064 Multiplex Laser
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment: 595/1064 Multiplex Laser
n=8 participants at risk
Subjects in the treatment arm will receive 3 treatments using the 595/1064 multiplex laser spaced by a four week interval (+/- 3 days), administered in an outpatient clinic setting. If a subject in the treatment arm has multiple BCCs satisfying inclusion criteria, all BCCs will be treated.
Four weeks (+/- 3 days) after the last treatment (Day 84) both treatment and control patients will be assessed for final clinical appearance, measurement, and evaluation of the lesion by a dermatologist.
Subjects will also undergo deep excisional biopsy encompassing the entire lesion to determine residual tumor cell presence. If histologic examination of the tissue reveals residual BCC, then the subject will receive standard of treatment.
595/1064 multiplex laser: 595/1064 multiplex laser will be used 3 times spaced by a four week interval (+/- 3 days), it will be administered in an outpatient clinic setting.
|
Control
n=4 participants at risk
Subjects in the control arm will receive 3 regular study visits spaced 4 weeks (+/- 3 days) apart. If a subject in the control arm has multiple BCCs satisfying inclusion criteria, all BCCs will not be treated.
Four weeks (+/- 3 days) after the last (Day 84) both treatment and control patients will be assessed for final clinical appearance, measurement, and evaluation of the lesion by a dermatologist.
Subjects will also undergo deep excisional biopsy encompassing the entire lesion to determine residual tumor cell presence. If histologic examination of the tissue reveals residual BCC, then the subject will receive standard of treatment.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Fibrosing on histology result
|
12.5%
1/8 • 91 days
|
0.00%
0/4 • 91 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place