Melanosis
Conditions
Brief summary
The purpose of this study is to find out the safety and effectiveness of 1064 Q-Switch Laser Therapy compared to Glycolic Acid Chemical Peels for the treatment of melasma.
Detailed description
Participants in this study will be patients at the dermatology clinic who are clinically diagnosed with at least a 2X2 cm patch of melasma on each side of their face (forehead or cheek). Starting at 2 weeks before treatment (week 2), both sides will be pretreated and primed with 4% hydroquinone with, if necessary, 2.5% hydrocortisone cream BID. On the treatment day (2-weeks) and 6-weeks one half of the subject's face will receive glycolic acid peels and the other half of the face will receive 1064nm Q-switch laser. This study is a pilot study designed to determine feasibility of these procedures.
Interventions
DEVICE1064nm Q-switch Laser
OTHERGlycolic Acid Peels
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Subjects aged 18 years or older 2. Subjects with at least a 2 x 2 cm patch of melasma on each side of the face (forehead or cheek) 3. Subjects in general good health 4. Subjects must be willing and able to understand and provide informed consent for the use of their tissue and communicate with the investigator 5. Subjects must be willing to not apply other treatment options for melasma during the course of the study
Exclusion criteria
1. Subjects under 18 years of age 2. Subjects who are pregnant and/or lactating 3. Subjects who are unable to understand the protocol or to give informed consent 4. Subjects diagnosed with mental illness 5. Subjects who have concurrent active uncontrolled disease to facial area (i.e uncontrolled acne) 6. Subjects who have had a chemical peel in the past 3 months 7. Subjects who have used a prescribed retinoid in the past 3 months 8. Subjects with a bleeding disorder 9. Subjects with a history of abnormal wound healing 10. Subjects with a history of abnormal scarring 11. Subjects who report being allergic to glycolic acid
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale (VAS) of Improvement Rated by a Blinded Dermatologist From at Week 10 | Week 10 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 9 |
| 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. | 9 |
| Total | 18 |
Baseline characteristics
| Characteristic | Glycolic Acid Peels Comparator Left, Q-Switch Laser Right | Total | Q-switch Laser Left, Glycolic Acid Peels Comparator Right |
|---|---|---|---|
| Age, Continuous | 44.11 years STANDARD_DEVIATION 11.94 | 42.94 years STANDARD_DEVIATION 11.03 | 41.78 years STANDARD_DEVIATION 10.62 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 4 Participants | 3 Participants |
| Race (NIH/OMB) White | 8 Participants | 12 Participants | 4 Participants |
| Sex: Female, Male Female | 9 Participants | 18 Participants | 9 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 3 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
Visual Analog Scale (VAS) of Improvement Rated by a Blinded Dermatologist From at Week 10
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.
Time frame: Week 10
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1064nm Q-switch Laser | 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 |
| Glycolic Acid Peels | Visual Analog Scale (VAS) of Improvement Rated by a Blinded Dermatologist From at Week 10 | 4.62 units on a scale | Standard Deviation 3.41 |