Trial Outcomes & Findings for Post Excision/Mohs Scar Laser Resurfacing (NCT NCT02130297)

Last Updated: 2021-04-19

Results Overview

modified Manchester scar scale (MMSS) treated - Full scale from 5 to 18, with higher score indicating lower health outcomes

Recruitment status

COMPLETED

Study phase

Target enrollment

30 participants

Primary outcome timeframe

Day 0 and Day 14

Results posted on

2021-04-19

Participant Flow

Original protocol had 3 arms. Due to difficulty with enrollment, study did not perform a laser treatment at 9 weeks and the enrolled participants were all given the same intervention.

Participant milestones

Participant milestones
Measure	Participants With Fitzpatrick Skin Phototype I or II Participants with wounds to limbs of Fitzpatrick skin phototype I or II to receive laser therapy to half of the scar the day of the excision, Day 0; and to the other half on Day 14.
Overall Study STARTED	30
Overall Study COMPLETED	26
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Participants With Fitzpatrick Skin Phototype I or II Participants with wounds to limbs of Fitzpatrick skin phototype I or II to receive laser therapy to half of the scar the day of the excision, Day 0; and to the other half on Day 14.
Overall Study Lost to Follow-up	4

Baseline Characteristics

Post Excision/Mohs Scar Laser Resurfacing

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Participants With Fitzpatrick Skin Phototype I or II n=30 Participants Participants with wounds to limbs of Fitzpatrick skin phototype I or II to receive laser therapy to half of the scar the day of the excision, Day 0; and to the other half on Day 14.
Age, Continuous	56 years n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	30 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Scar length	6.4 cm n=5 Participants

PRIMARY outcome

Timeframe: Day 0 and Day 14

modified Manchester scar scale (MMSS) treated - Full scale from 5 to 18, with higher score indicating lower health outcomes

Outcome measures

Outcome measures
Measure	Participants With Fitzpatrick Skin Phototype I or II n=26 Participants Participants with wounds to limbs of Fitzpatrick skin phototype I or II to receive laser therapy to half of the scar the day of the excision, Day 0; and to the other half on Day 14.
MMSS for Scar Halves Treated Day 0	8.4 score on a scale Interval 7.0 to 10.0
MMSS for Scar Halves Treated Day 14	8.7 score on a scale Interval 7.0 to 11.0

SECONDARY outcome

Timeframe: Day 0 and Day 14

Fd indicates scar tissue density - a measure of how completely an object fills space and increases in value with increasing structural density. It has a value between 1 and 2: a minimum value of 1 corresponds to a straight line filling the space, and a maximum value of 2 corresponds to an object completely occupying the entire space. Lacunarity describes the characteristics of fractals of the same dimension with different texture appearances and indicates scar tissue architecture (homogeneous vs. heterogeneous) - a measure of the nonuniformity (heterogeneity) of a structure or the degree of structural variance within an object. L has a value between 0 and 1, where a minimum value of 0 corresponds to an absolute homogeneous object.

Outcome measures

Outcome measures
Measure	Participants With Fitzpatrick Skin Phototype I or II n=30 Participants Participants with wounds to limbs of Fitzpatrick skin phototype I or II to receive laser therapy to half of the scar the day of the excision, Day 0; and to the other half on Day 14.
Quantitative Scar Analysis as Measured by Fractal Dimension (Fd) and Lacunarity Fractal dimension (Fd) Day 0	1.778 units on a scale Interval 1.691 to 1.83
Quantitative Scar Analysis as Measured by Fractal Dimension (Fd) and Lacunarity Fractal dimension (Fd) Day 14	1.781 units on a scale Interval 1.706 to 1.831
Quantitative Scar Analysis as Measured by Fractal Dimension (Fd) and Lacunarity Lacunarity Day 0	0.368 units on a scale Interval 0.225 to 0.637
Quantitative Scar Analysis as Measured by Fractal Dimension (Fd) and Lacunarity Lacunarity Day 14	0.345 units on a scale Interval 0.214 to 0.573

SECONDARY outcome

Timeframe: 24 weeks post-op

Population: Data not collected

Comparison of scars using quartile scale: 0 indicates no difference, 1 indicates a 1-25% difference or "mild" difference, 2 indicates a 26-50% or moderate difference, 3 indicates a 51-75% or significant improvement and 4 indicates a 76-100% difference or very significant.

Outcome measures

Outcome data not reported

Adverse Events

Participants With Fitzpatrick Skin Phototype I or II

Serious events: 0 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Participants With Fitzpatrick Skin Phototype I or II n=26 participants at risk Participants with wounds to limbs of Fitzpatrick skin phototype I or II to receive laser therapy to half of the scar the day of the excision, Day 0; and to the other half on Day 14.
Skin and subcutaneous tissue disorders transient erythema	76.9% 20/26 • 6 months
Skin and subcutaneous tissue disorders swelling and crusting	76.9% 20/26 • 6 months

Additional Information

Dr. Hooman Khorasani

Icahn School of Medicine at Mount Sinai

Phone: 347-574-8500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place