Trial Outcomes & Findings for Treatment of Post-Surgical Scars With Traditional Ablative Er:YAG Versus Fractional Ablative Er:YAG (NCT NCT02397564)
NCT ID: NCT02397564
Last Updated: 2017-08-01
Results Overview
It uses a 10-point scoring system with a score of 1 representing a normal-appearing skin and a score of 10 representing the worst possible scar. Total scores range from 6 to 60 with the lower score indicate a better outcome.
COMPLETED
NA
20 participants
5 months
2017-08-01
Participant Flow
Participant milestones
| Measure |
Intervention Group
Enroll 20 patients for nonsurgical treatment of surgical scars. Half of each scar will be treated with the Er:YAG laser on the traditional ablative setting and the other half of the scar will receive Er:YAG treatment with the fractional ablative setting. The patients will receive 3 treatments at monthly intervals. They will follow up at 1 and 2 months after the treatment.
Er:YAG laser, traditional and fractional settings: Half the scar will be treated with traditional ablative setting and the other half will be treated with the fractional ablative setting
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
16
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Treatment of Post-Surgical Scars With Traditional Ablative Er:YAG Versus Fractional Ablative Er:YAG
Baseline characteristics by cohort
| Measure |
Treatment Group
n=20 Participants
Enroll 20 patients for nonsurgical treatment of surgical scars. Half of each scar will be treated with the Er:YAG laser on the traditional ablative setting and the other half of the scar will receive Er:YAG treatment with the fractional ablative setting. The patients will receive 3 treatments at monthly intervals. They will follow up at 1 and 2 months after the treatment.
Er:YAG laser, traditional and fractional settings: Half the scar will be treated with traditional ablative setting and the other half will be treated with the fractional ablative setting
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
46 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 5 monthsIt uses a 10-point scoring system with a score of 1 representing a normal-appearing skin and a score of 10 representing the worst possible scar. Total scores range from 6 to 60 with the lower score indicate a better outcome.
Outcome measures
| Measure |
Treatment Group
n=16 Participants
Subjects receiving treatment for scar
|
|---|---|
|
Patient Observer Scar Assessment Scale (POSAS)
Physician Fully Ablative Laser
|
17.69 units on a scale
Standard Error 2.03
|
|
Patient Observer Scar Assessment Scale (POSAS)
Physician Fractionated Laser
|
11.2 units on a scale
Standard Error 2.03
|
|
Patient Observer Scar Assessment Scale (POSAS)
Patients Fully Ablative Laser
|
15.2 units on a scale
Standard Error 1.58
|
|
Patient Observer Scar Assessment Scale (POSAS)
Patients Fractionated Laser
|
11.4 units on a scale
Standard Error 1.58
|
SECONDARY outcome
Timeframe: 5 monthsPopulation: Those who expressed a preference.
The number of patients who preferred the fractionated laser
Outcome measures
| Measure |
Treatment Group
n=16 Participants
Subjects receiving treatment for scar
|
|---|---|
|
Patient Preference
|
15 Participants
|
Adverse Events
Treatment Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place