Trial Outcomes & Findings for 755nm Alex Laser for Treatment of Pigmented and Vascular Lesions and Scars (NCT NCT01745627)

Last Updated: 2020-12-23

Results Overview

This scale ranges from 0 to 3, where 0 is 0-25% clearance, 1 is 26-50% clearance, 2 is 51-75% clearance and 3 is 76-100% clearance. The baseline picture was compared to a photograph taken at the follow up visit. The number of patients that fell into each category was recorded.

Recruitment status

COMPLETED

Study phase

Target enrollment

43 participants

Primary outcome timeframe

1 months post last treatment

Results posted on

2020-12-23

Participant Flow

1 subject ID was never assigned, so the # of subjects who started the subject was actually 1 less than what the protocol said.

Participant milestones

Participant milestones
Measure	Laser Treatment 755nm Alex laser
Overall Study STARTED	42
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	22

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

755nm Alex Laser for Treatment of Pigmented and Vascular Lesions and Scars

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Laser Treatment n=42 Participants 755nm Alex laser
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	41 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	36 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Caucasian	24 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Asian	6 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Hispanic	9 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · African American	2 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Hispanic/Other	1 Participants n=5 Participants
Fitzpatrick Skin Score Fitzpatrick Skin Type I	4 Participants n=5 Participants
Fitzpatrick Skin Score Fitzpatrick Skin Type II	14 Participants n=5 Participants
Fitzpatrick Skin Score Fitzpatrick Skin Type III	14 Participants n=5 Participants
Fitzpatrick Skin Score Fitzpatrick Skin Type IV	6 Participants n=5 Participants
Fitzpatrick Skin Score Fitzpatrick Skin Type V	3 Participants n=5 Participants
Fitzpatrick Skin Score Fitzpatrick Skin Type VI	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 months post last treatment

Population: 19 subjects were lost to follow up after their treatment. 2 subjects did not have clearance data but had photographs for each of the follow up visits. 4 subjects did not attend the 1 month follow up, but attended a 3 month follow up, so their data was included. 2 subjects were not included in the trial.

Outcome measures

Outcome measures
Measure	Laser Treatment n=15 Participants 755nm Alex laser
Clearance Based on Photographic Scale >75%	2 Participants
Clearance Based on Photographic Scale 51-74%	2 Participants
Clearance Based on Photographic Scale 26-50%	4 Participants
Clearance Based on Photographic Scale 0-25%	7 Participants

PRIMARY outcome

Timeframe: 3 months post last treatment

Population: 19 subjects were lost to follow up, 2 subjects did not have clearance data but had photographs for each of the follow up visits. 6 subjects did not have data for this follow up visit but had data for the 1 month follow up visit, so their data were included. 2 subjects were not included in the trial.

Outcome measures

Outcome measures
Measure	Laser Treatment n=13 Participants 755nm Alex laser
Clearance Based on Photographic Scale >75%	2 Participants
Clearance Based on Photographic Scale 51-74%	2 Participants
Clearance Based on Photographic Scale 26-50%	4 Participants
Clearance Based on Photographic Scale 0-25%	5 Participants

Adverse Events

Laser Treatment

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Laser Treatment n=42 participants at risk 755nm Alex laser
Skin and subcutaneous tissue disorders Redness	11.9% 5/42 • Adverse Events occurring were captured and followed for each patient's participation in the study, approximately 26 months.
Skin and subcutaneous tissue disorders Swelling	2.4% 1/42 • Adverse Events occurring were captured and followed for each patient's participation in the study, approximately 26 months.
Skin and subcutaneous tissue disorders Crusting	14.3% 6/42 • Adverse Events occurring were captured and followed for each patient's participation in the study, approximately 26 months.
Skin and subcutaneous tissue disorders Blistering	14.3% 6/42 • Adverse Events occurring were captured and followed for each patient's participation in the study, approximately 26 months.
Skin and subcutaneous tissue disorders Hypopigmentation	2.4% 1/42 • Adverse Events occurring were captured and followed for each patient's participation in the study, approximately 26 months.
Skin and subcutaneous tissue disorders Hyperpigmentation	2.4% 1/42 • Adverse Events occurring were captured and followed for each patient's participation in the study, approximately 26 months.
Skin and subcutaneous tissue disorders Puritis	2.4% 1/42 • Adverse Events occurring were captured and followed for each patient's participation in the study, approximately 26 months.
Infections and infestations Infection	2.4% 1/42 • Adverse Events occurring were captured and followed for each patient's participation in the study, approximately 26 months.

Additional Information

Jamie Trimper

Cynosure

Phone: 800-886-2966

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The PI cannot disclose confidential or proprietary information until after it becomes generally known or available to the public.
Publication restrictions are in place

Restriction type: OTHER