Trial Outcomes & Findings for A Pilot Study Testing 1064nm Q-switch Laser Versus Glycolic Acid Peels for the Treatment of Melasma (NCT NCT01976273)
NCT ID: NCT01976273
Last Updated: 2021-12-06
Results Overview
The primary outcome was a blinded rating of improvement of the treatment area (1064nm Q-switch Laser Versus Glycolic Acid Peels) using a Visual Analog Scale (VAS). A dermatologist blindly evaluated the treated areas of each side from live subjects at baseline on the final follow up visit (week 10). The VAS of improvement was rated on a scale of 0 to10, with 0 being no improvement and 10 being the most improvement seen by the treatment.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
Week 10
Results posted on
2021-12-06
Participant Flow
Participant milestones
| Measure |
Q-switch Laser Left, Glycolic Acid Peels Comparator Right
The unit of randomization was the subject who was randomized 1:1 to receive glycolic acid peel on one side of the face, while the contralateral side of the face received the 1064nm Q-switch laser.
Subjects in this arm were randomized to receive the interventions: 1064nm Q-switch laser on the left side of their face, and the glycolic acids peels on the right side of their face.
|
Glycolic Acid Peels Comparator Left, Q-Switch Laser Right
The unit of randomization was the subject who was randomized 1:1 to receive glycolic acid peel on one side of the face, while the contralateral side of the face received the 1064nm Q-switch laser.
Subjects in this arm were randomized to receive the interventions: 1064nm Q-switch laser on the right side of their face, and the glycolic acids peels on the left side of their face.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
9
|
9
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Pilot Study Testing 1064nm Q-switch Laser Versus Glycolic Acid Peels for the Treatment of Melasma
Baseline characteristics by cohort
| Measure |
Q-switch Laser Left, Glycolic Acid Peels Comparator Right
n=9 Participants
The unit of randomization was the subject who was randomized 1:1 to receive glycolic acid peel on one side of the face, while the contralateral side of the face received the 1064nm Q-switch laser.
Subjects in this arm were randomized to receive the interventions: 1064nm Q-switch laser on the left side of their face, and the glycolic acids peels on the right side of their face.
|
Glycolic Acid Peels Comparator Left, Q-Switch Laser Right
n=9 Participants
The unit of randomization was the subject who was randomized 1:1 to receive glycolic acid peel on one side of the face, while the contralateral side of the face received the 1064nm Q-switch laser.
Subjects in this arm were randomized to receive the interventions: 1064nm Q-switch laser on the right side of their face, and the glycolic acids peels on the left side of their face.
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.78 years
STANDARD_DEVIATION 10.62 • n=5 Participants
|
44.11 years
STANDARD_DEVIATION 11.94 • n=7 Participants
|
42.94 years
STANDARD_DEVIATION 11.03 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 10The primary outcome was a blinded rating of improvement of the treatment area (1064nm Q-switch Laser Versus Glycolic Acid Peels) using a Visual Analog Scale (VAS). A dermatologist blindly evaluated the treated areas of each side from live subjects at baseline on the final follow up visit (week 10). The VAS of improvement was rated on a scale of 0 to10, with 0 being no improvement and 10 being the most improvement seen by the treatment.
Outcome measures
| Measure |
1064nm Q-switch Laser
n=18 Participants
The 1064 Q-Switch Laser is a medical device that uses a focused laser to remove dark pigment (color) from the skin.
1064nm Q-switch Laser
|
Glycolic Acid Peels
n=18 Participants
A Glycolic Acid Chemical Peel is a mild skin treatment used to correct uneven texture and color by removing dead cells from the skin's outermost layer.
Glycolic Acid Peels
|
|---|---|---|
|
Visual Analog Scale (VAS) of Improvement Rated by a Blinded Dermatologist From at Week 10
|
4.37 units on a scale
Standard Deviation 2.49
|
4.62 units on a scale
Standard Deviation 3.41
|
Adverse Events
1064nm Q-switch Laser
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Glycolic Acid Peels
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
1064nm Q-switch Laser
n=20 participants at risk
The 1064 Q-Switch Laser is a medical device that uses a focused laser to remove dark pigment (color) from the skin.
1064nm Q-switch Laser
|
Glycolic Acid Peels
n=20 participants at risk
A Glycolic Acid Chemical Peel is a mild skin treatment used to correct uneven texture and color by removing dead cells from the skin's outermost layer.
Glycolic Acid Peels
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation
|
0.00%
0/20 • 6 months
|
5.0%
1/20 • Number of events 1 • 6 months
|
|
Skin and subcutaneous tissue disorders
Blistering/Scabbing
|
0.00%
0/20 • 6 months
|
10.0%
2/20 • Number of events 2 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place