Trial Outcomes & Findings for Long-pulsed 1064 nm Nd:YAG Laser Treatment of Basal Cell Carcinoma (NCT NCT02662244)

Results Overview

The primary outcome data collected during the study will include: * Number of tumors that showed histologic complete regression.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

33 participants

Primary outcome timeframe

The primary outcome of the study is histologic clearance of BCC tumor 30 days

Results posted on

2019-09-06

Participant Flow

Thirty-three subjects seeking treatment for biopsy-proven BCC that did not meet the criteria for Mohs surgery were recruited from the clinic

Participant milestones

Participant milestones
Measure	All Participants Subjects received one treatment with the 1064 nm Nd:YAG laser as follows: 5-6 mm spot, fluence of 125-140 J/cm2 and a pulse duration of 7-10 ms. Standard excision with 5 mm clinical margins was performed at 30 days after laser treatment to evaluate clinical and histologic clearance of BCC.
Overall Study STARTED	33
Overall Study COMPLETED	31
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Long-pulsed 1064 nm Nd:YAG Laser Treatment of Basal Cell Carcinoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Yag Laser Treatment Of Basal Cell Carcinoma n=31 Participants Thirty-one subjects seeking treatment for biopsy-proven BCC that did not meet the criteria for Mohs surgery were recruited. Subjects on current anticoagulation therapy, or with a history of immunosuppression were excluded. Subjects received one treatment with the 1064 nm Nd:YAG laser as follows: 5-6 mm spot, fluence of 125-140 J/cm2 and a pulse duration of 7-10 ms. Standard excision with 5 mm clinical margins was performed at 30 days after laser treatment to evaluate clinical and histologic clearance of BCC. Standardized photographs and adverse assessments were taken at the baseline visit, immediately after laser treatment and on the day of excision. Nd:YAG laser: Long-Pulsed 1064 NM ND:Yag Laser Treatment Of Basal Cell Carcinoma
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants
Age, Categorical >=65 years	11 Participants n=5 Participants
Age, Continuous	56 years n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants
Region of Enrollment United States	31 participants n=5 Participants

PRIMARY outcome

Timeframe: The primary outcome of the study is histologic clearance of BCC tumor 30 days

Population: 31 Adults over 18 years with a biopsy-proven BCC of any non-aggressive subtype with a residual clinical lesion were included. BCC lesions were required to be less than 2.1 cm in diameter and located on the trunk or extremities. The number of tumors that showed complete regression were analyzed for primary outcome.

The primary outcome data collected during the study will include: * Number of tumors that showed histologic complete regression.

Outcome measures

Outcome measures
Measure	Single Arm n=31 tumors Study participants will be treated with long-pulsed 1064 nm Nd:YAG laser at the investigator's discretion based on the clinical endpoint (slight contraction and greying of the skin surface), the tumor characteristics, and the patient's skin phototype. Nd:YAG laser: Long-Pulsed 1064 NM ND:Yag Laser Treatment Of Basal Cell Carcinoma
This is a Study to Measure the Efficacy of the Nd:YAG Laser to Cause Complete Regression of Basal Cell Carcinoma.	28 tumors

SECONDARY outcome

Timeframe: 30 days

Population: All participants' purpura was analyzed on a scale of 0 to 3

11\. The treatment area will be assessed post laser and at the final evaluation visit for purpura using the following scale: * 0 = absence * 1 = mild * 2 = moderate * 3 = severe

Outcome measures

Outcome measures
Measure	Single Arm n=31 purpura Study participants will be treated with long-pulsed 1064 nm Nd:YAG laser at the investigator's discretion based on the clinical endpoint (slight contraction and greying of the skin surface), the tumor characteristics, and the patient's skin phototype. Nd:YAG laser: Long-Pulsed 1064 NM ND:Yag Laser Treatment Of Basal Cell Carcinoma
• Clinical and Photographic Evidence of Extent of Purpura After Each Treatment post baseline (5 minutes)	0.523809524 score on a scale Interval 0.0 to 3.0
• Clinical and Photographic Evidence of Extent of Purpura After Each Treatment final visit (30 days)	0 score on a scale Interval 0.0 to 3.0

SECONDARY outcome

Timeframe: 30 days

Population: Clinical and photographic evidence of extent of edema was evaluated by the investigator with the above scores at b

3\. The treatment area will be assessed for edema using the following scale: * 0 = absence * 1 = mild * 2 = moderate * 3 = severe

Outcome measures

Outcome measures
Measure	Single Arm n=31 Participants Study participants will be treated with long-pulsed 1064 nm Nd:YAG laser at the investigator's discretion based on the clinical endpoint (slight contraction and greying of the skin surface), the tumor characteristics, and the patient's skin phototype. Nd:YAG laser: Long-Pulsed 1064 NM ND:Yag Laser Treatment Of Basal Cell Carcinoma
• Clinical and Photographic Evidence of Extent of Edema Occurring After Each Treatment final visit (30 days)	0 score on a scale Interval 0.0 to 3.0
• Clinical and Photographic Evidence of Extent of Edema Occurring After Each Treatment post baseline treatment (5 minutes)	1.428571429 score on a scale Interval 0.0 to 3.0

SECONDARY outcome

Timeframe: 30 days

Population: Clinical and photographic evidence of extent of erythema was evaluated by the investigator with the above scores.

The treatment area will be assessed for erythema using the following scale: * 0 = absence * 1 = mild * 2 = moderate * 3 = severe

Outcome measures

Outcome measures
Measure	Single Arm n=31 erythema Study participants will be treated with long-pulsed 1064 nm Nd:YAG laser at the investigator's discretion based on the clinical endpoint (slight contraction and greying of the skin surface), the tumor characteristics, and the patient's skin phototype. Nd:YAG laser: Long-Pulsed 1064 NM ND:Yag Laser Treatment Of Basal Cell Carcinoma
Clinical and Photographic Evidence of Extent of Erythema Occurring After Each Treatment post baseline treatment (5 minutes)	1.571428571 score on a scale Interval 0.0 to 3.0
Clinical and Photographic Evidence of Extent of Erythema Occurring After Each Treatment final visit (30 days)	1.095238095 score on a scale Interval 0.0 to 3.0

SECONDARY outcome

Timeframe: 30 days

Population: Clinical and photographic evidence of extent of blistering after treatment was evaluated by the investigator with the above scores

The treatment area will be assessed for blistering using the following scale: * 0 = absence * 1 = mild * 2 = moderate * 3 = severe

Outcome measures

Outcome measures
Measure	Single Arm n=31 blistering Study participants will be treated with long-pulsed 1064 nm Nd:YAG laser at the investigator's discretion based on the clinical endpoint (slight contraction and greying of the skin surface), the tumor characteristics, and the patient's skin phototype. Nd:YAG laser: Long-Pulsed 1064 NM ND:Yag Laser Treatment Of Basal Cell Carcinoma
Clinical and Photographic Evidence of Extent of Blistering Occurring After Each Treatment post baseline treatment (5 minutes)	1.19047619 score on a scale Interval 0.0 to 3.0
Clinical and Photographic Evidence of Extent of Blistering Occurring After Each Treatment final visit (30 days)	0.047619048 score on a scale Interval 0.0 to 3.0

Adverse Events

Yag Laser Treatment Of Basal Cell Carcinoma

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Yag Laser Treatment Of Basal Cell Carcinoma n=31 participants at risk Single arm/group study Study participants will be treated with a long-pulsed 1064 nm Nd:YAG laser with a 5-7 mm spot, an approximate fluence of 100-200 J/cm2 and a pulse duration of 3-15ms determined somewhat at the investigator's discretion based on the clinical endpoint (slight contraction and greying of the skin surface), the tumor characteristics, and the patient's skin phototype. There will be no randomization.
Skin and subcutaneous tissue disorders pain	3.2% 1/31 • Number of events 1 Laser pulses will produce an immediate sensation comparable to a pin-prick or rubber band snapping against the skin (mild to moderate pain) at the treatment site, and there may be a transient sensation of sunburn after irradiation that disappears over a period of several days. All effects of laser are localized reactions like erythema, purpura, scabbing, localized hypo, hyperpigmentation. Risk of mortality cannot be expected from localized treatment.

Additional Information

Dr. Arisa Ortiz

UCSD

Phone: 858-657-1697

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place