Trial Outcomes & Findings for Comparison of 1,550 and 755 Laser in a Split-face Trial (NCT NCT03988049)
NCT ID: NCT03988049
Last Updated: 2021-06-29
Results Overview
Change in Baseline acne scarring compared to week 24 measured by photographic review. Measured by blinded reviewer assessments of photographs.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
22 participants
Primary outcome timeframe
Photos will be taken at week 0, week 4, week 8, and week 24.
Results posted on
2021-06-29
Participant Flow
Unit of analysis: half faces of subjects
Participant milestones
| Measure |
1,550 Laser
All subjects on this arm will be treated on this split-faced. This arm is looking at the side of the face treated with the 1,550-nanometer Fracionated Photothermolysis laser.
1,550 fracionated photothermolysis laser vs. 755 picosecond laser: All subjects will have one side of their face treated with one laser, and the other side with the other laser.
|
755 Laser
All subjects on this arm will be treated on this split-faced. This arm is the side of their face will be treated with the 755-nanometer alexandrite picosecond laser.
1,550 fracionated photothermolysis laser vs. 755 picosecond laser: All subjects will have one side of their face treated with one laser, and the other side with the other laser.
|
|---|---|---|
|
Overall Study
STARTED
|
22 22
|
22 22
|
|
Overall Study
COMPLETED
|
22 22
|
22 22
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Number of units analyzed was 2 per participant.
Baseline characteristics by cohort
| Measure |
1,550 Laser
n=22 half faces
All subjects on this arm will be treated on this split-faced. This arm consists of the half-faces treated with the 1,550-nanometer Fracionated Photothermolysis laser.
1,550 fracionated photothermolysis laser vs. 755 picosecond laser: All subjects will have one side of their face treated with one laser, and the other side with the other laser.
|
755 Laser
n=22 half faces
All subjects on this arm will be treated on this split-faced. This arm consists of the half-faces treated with the 755-nanometer alexandrite picosecond laser.
1,550 fracionated photothermolysis laser vs. 755 picosecond laser: All subjects will have one side of their face treated with one laser, and the other side with the other laser.
|
Total
n=44 half faces
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants • Number of units analyzed was 2 per participant.
|
0 Participants
n=7 Participants • Number of units analyzed was 2 per participant.
|
0 Participants
n=5 Participants • Number of units analyzed was 2 per participant.
|
|
Age, Categorical
Between 18 and 65 years
|
22 Participants
n=5 Participants • Number of units analyzed was 2 per participant.
|
22 Participants
n=7 Participants • Number of units analyzed was 2 per participant.
|
44 Participants
n=5 Participants • Number of units analyzed was 2 per participant.
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants • Number of units analyzed was 2 per participant.
|
0 Participants
n=7 Participants • Number of units analyzed was 2 per participant.
|
0 Participants
n=5 Participants • Number of units analyzed was 2 per participant.
|
|
Age, Continuous
|
33 years
STANDARD_DEVIATION 14.28 • n=5 Participants • the number of units analyzed was 2 per participant.
|
33 years
STANDARD_DEVIATION 14.28 • n=7 Participants • the number of units analyzed was 2 per participant.
|
33 years
STANDARD_DEVIATION 14.28 • n=5 Participants • the number of units analyzed was 2 per participant.
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants • the number of units analyzed was 2 per participant.
|
10 Participants
n=7 Participants • the number of units analyzed was 2 per participant.
|
20 Participants
n=5 Participants • the number of units analyzed was 2 per participant.
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants • the number of units analyzed was 2 per participant.
|
12 Participants
n=7 Participants • the number of units analyzed was 2 per participant.
|
24 Participants
n=5 Participants • the number of units analyzed was 2 per participant.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants • the number of units analyzed was 2 per participant.
|
0 Participants
n=7 Participants • the number of units analyzed was 2 per participant.
|
0 Participants
n=5 Participants • the number of units analyzed was 2 per participant.
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants • the number of units analyzed was 2 per participant.
|
2 Participants
n=7 Participants • the number of units analyzed was 2 per participant.
|
4 Participants
n=5 Participants • the number of units analyzed was 2 per participant.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants • the number of units analyzed was 2 per participant.
|
0 Participants
n=7 Participants • the number of units analyzed was 2 per participant.
|
0 Participants
n=5 Participants • the number of units analyzed was 2 per participant.
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants • the number of units analyzed was 2 per participant.
|
2 Participants
n=7 Participants • the number of units analyzed was 2 per participant.
|
4 Participants
n=5 Participants • the number of units analyzed was 2 per participant.
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants • the number of units analyzed was 2 per participant.
|
15 Participants
n=7 Participants • the number of units analyzed was 2 per participant.
|
30 Participants
n=5 Participants • the number of units analyzed was 2 per participant.
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants • the number of units analyzed was 2 per participant.
|
3 Participants
n=7 Participants • the number of units analyzed was 2 per participant.
|
6 Participants
n=5 Participants • the number of units analyzed was 2 per participant.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants • the number of units analyzed was 2 per participant.
|
0 Participants
n=7 Participants • the number of units analyzed was 2 per participant.
|
0 Participants
n=5 Participants • the number of units analyzed was 2 per participant.
|
|
Region of Enrollment
United States
|
22 participants
n=5 Participants • the number of units analyzed was 2 per participant.
|
22 participants
n=7 Participants • the number of units analyzed was 2 per participant.
|
22 participants
n=5 Participants • the number of units analyzed was 2 per participant.
|
PRIMARY outcome
Timeframe: Photos will be taken at week 0, week 4, week 8, and week 24.Change in Baseline acne scarring compared to week 24 measured by photographic review. Measured by blinded reviewer assessments of photographs.
Outcome measures
| Measure |
1,550 Laser
n=22 half faces
All subjects on this arm will be treated on this split-faced. This arm is looking at the side of the face treated with the 1,550-nanometer Fracionated Photothermolysis laser.
1,550 fracionated photothermolysis laser vs. 755 picosecond laser: All subjects will have one side of their face treated with one laser, and the other side with the other laser.
|
755 Laser
n=22 half faces
All subjects on this arm will be treated on this split-faced. This arm is the side of their face will be treated with the 755-nanometer alexandrite picosecond laser.
1,550 fracionated photothermolysis laser vs. 755 picosecond laser: All subjects will have one side of their face treated with one laser, and the other side with the other laser.
|
|---|---|---|
|
Number of Half Faces to Achieve at Least 25% Improvement in Acne Scarring at Week 24 by Blinded Photo Reviewer
|
18 half faces
|
17 half faces
|
Adverse Events
1,550 Laser
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
755 Laser
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
1,550 Laser
n=22 participants at risk
This arm is the side of the face treated with the 1550-nanometer Fracionated Photothermolysis laser.
1,550 fracionated photothermolysis laser: All subjects will have one side of their face treated with one laser, and the other side with the other laser.
|
755 Laser
n=22 participants at risk
This arm is the side of the face treated with the 755-nanometer alexandrite picosecond laser.
755 picosecond laser: All subjects will have one side of their face treated with one laser, and the other side with the other laser.
|
|---|---|---|
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Skin and subcutaneous tissue disorders
Transient Erythema
|
100.0%
22/22 • Number of events 22 • Adverse events (anticipated and unanticipated) related to study treatments/procedures (based on the judgment of an investigator) were collected from the time of signed consent through week 24.
The adverse events collected for this study differ from the clinicaltrials.gov definition in that the adverse events collected were only considered related to the participant's participation in the research.
|
100.0%
22/22 • Number of events 22 • Adverse events (anticipated and unanticipated) related to study treatments/procedures (based on the judgment of an investigator) were collected from the time of signed consent through week 24.
The adverse events collected for this study differ from the clinicaltrials.gov definition in that the adverse events collected were only considered related to the participant's participation in the research.
|
|
Skin and subcutaneous tissue disorders
Transient Crusting or Blistering
|
100.0%
22/22 • Number of events 22 • Adverse events (anticipated and unanticipated) related to study treatments/procedures (based on the judgment of an investigator) were collected from the time of signed consent through week 24.
The adverse events collected for this study differ from the clinicaltrials.gov definition in that the adverse events collected were only considered related to the participant's participation in the research.
|
100.0%
22/22 • Number of events 22 • Adverse events (anticipated and unanticipated) related to study treatments/procedures (based on the judgment of an investigator) were collected from the time of signed consent through week 24.
The adverse events collected for this study differ from the clinicaltrials.gov definition in that the adverse events collected were only considered related to the participant's participation in the research.
|
Additional Information
Dr. David Smart, Assistant Professor, Dermatology
University of Utah Dermatology
Phone: 8015816465
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place