Trial Outcomes & Findings for Evaluation of the 755nm Alexandrite Laser for the Treatment of Scars (NCT NCT01811030)

Last Updated: 2021-01-14

Results Overview

The échelle d'évaluation clinique des cicatrices d'acné (ECCA) Grading scale was used to evaluate the photographs, using 2D and 3D photography, where the scale ranges from 0 to 4. 0 represents 0% improvement/worse, 1 is 1-25% improvement, 2 is 26-50% improvement, 3 is 51-74% improvement, and 4 is \>75% improvement.

Recruitment status

COMPLETED

Study phase

Target enrollment

33 participants

Primary outcome timeframe

1 Month Post Last Treatment

Results posted on

2021-01-14

Participant Flow

Participant milestones

Participant milestones
Measure	755nm Alexandrite Laser 755nm Alexandrite Laser 755nm Alexandrite Laser: 755nm Alexandrite Laser
Overall Study STARTED	33
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	13

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of the 755nm Alexandrite Laser for the Treatment of Scars

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	755nm Alexandrite Laser n=33 Participants 755nm Alexandrite Laser 755nm Alexandrite Laser: 755nm Alexandrite Laser
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	32 Participants n=93 Participants
Age, Categorical >=65 years	1 Participants n=93 Participants
Sex: Female, Male Female	25 Participants n=93 Participants
Sex: Female, Male Male	8 Participants n=93 Participants
Race/Ethnicity, Customized Race/Ethnicity · Caucasian	21 Participants n=93 Participants
Race/Ethnicity, Customized Race/Ethnicity · Hispanic	2 Participants n=93 Participants
Race/Ethnicity, Customized Race/Ethnicity · Asian	4 Participants n=93 Participants
Race/Ethnicity, Customized Race/Ethnicity · Black	6 Participants n=93 Participants
Fitzpatrick Skin Type Fitzpatrick Skin Type I	2 Participants n=93 Participants
Fitzpatrick Skin Type Fitzpatrick Skin Type II	12 Participants n=93 Participants
Fitzpatrick Skin Type Fitzpatrick Skin Type III	9 Participants n=93 Participants
Fitzpatrick Skin Type Fitzpatrick Skin Type IV	4 Participants n=93 Participants
Fitzpatrick Skin Type Fitzpatrick Skin Type V	4 Participants n=93 Participants
Fitzpatrick Skin Type Fitzpatrick Skin Type VI	2 Participants n=93 Participants

PRIMARY outcome

Timeframe: 1 Month Post Last Treatment

Population: 7 subjects were lost to follow up. 3 subjects withdrew. 1 subject cancelled multiple appointments and could not come in.

Outcome measures

Outcome measures
Measure	755nm Alexandrite Laser n=22 Participants 755nm Alexandrite Laser 755nm Alexandrite Laser: 755nm Alexandrite Laser
Photographic Evaluation of Scar Clearance	1.82 score on a scale Standard Deviation .73

PRIMARY outcome

Timeframe: 3 Months Post Last Treatment

Population: 9 subjects were lost to follow up. 3 subjects withdrew. 1 subject was not done due to patient's non-compliance. 2 subjects did not record overall clearance for this follow up.

Outcome measures

Outcome measures
Measure	755nm Alexandrite Laser n=18 Participants 755nm Alexandrite Laser 755nm Alexandrite Laser: 755nm Alexandrite Laser
Photographic Evaluation of Scar Clearance	2.28 score on a scale Standard Deviation .75

Adverse Events

755nm Alexandrite Laser

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	755nm Alexandrite Laser n=33 participants at risk 755nm Alexandrite Laser 755nm Alexandrite Laser: 755nm Alexandrite Laser
Nervous system disorders Pain	3.0% 1/33 • Adverse Events occurring will be captured and followed throughout patients' participation in the study, approximately 17 months.
Skin and subcutaneous tissue disorders Redness	42.4% 14/33 • Adverse Events occurring will be captured and followed throughout patients' participation in the study, approximately 17 months.
Skin and subcutaneous tissue disorders Swelling	6.1% 2/33 • Adverse Events occurring will be captured and followed throughout patients' participation in the study, approximately 17 months.
Skin and subcutaneous tissue disorders Crusting	3.0% 1/33 • Adverse Events occurring will be captured and followed throughout patients' participation in the study, approximately 17 months.
Skin and subcutaneous tissue disorders Blistering	3.0% 1/33 • Adverse Events occurring will be captured and followed throughout patients' participation in the study, approximately 17 months.
Skin and subcutaneous tissue disorders Hypopigmentation	3.0% 1/33 • Adverse Events occurring will be captured and followed throughout patients' participation in the study, approximately 17 months.
Skin and subcutaneous tissue disorders Hyperpigmentation	6.1% 2/33 • Adverse Events occurring will be captured and followed throughout patients' participation in the study, approximately 17 months.
Skin and subcutaneous tissue disorders Pruritus	3.0% 1/33 • Adverse Events occurring will be captured and followed throughout patients' participation in the study, approximately 17 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