Trial Outcomes & Findings for Study of Laser Treatment of Melasma (NCT NCT01335581)
NCT ID: NCT01335581
Last Updated: 2022-01-13
Results Overview
The severity of the melasma is assessed based on a photographic scale. The scale ranges from 0 to 48, with 48 being the most severe. A decrease in the MASI score from the baseline to the follow up corresponds with decreasing severity.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
18 participants
Primary outcome timeframe
3 Months
Results posted on
2022-01-13
Participant Flow
Participant milestones
| Measure |
Laser Treatment
Laser treatment added to microdermabrasion and topical lightening agent regimen
Q-Switched Nd:YAG Laser (RevLite): Laser treatment added to a microdermabrasion and topical lightening agent regimen
|
Control Group
Microdermabrasion and skin lightening regimen
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
9
|
|
Overall Study
COMPLETED
|
5
|
3
|
|
Overall Study
NOT COMPLETED
|
4
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Laser Treatment of Melasma
Baseline characteristics by cohort
| Measure |
Laser Treatment
n=9 Participants
Laser treatment added to microdermabrasion and topical lightening agent regimen
Q-Switched Nd:YAG Laser (RevLite): Laser treatment added to a microdermabrasion and topical lightening agent regimen
|
Control Group
n=9 Participants
Microdermabrasion and topical lightening agent regimen
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
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/Ethnicity, Customized
Race/Ethnicity · Caucasian
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Spanish/Hispanic
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Indian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Asian-American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Fitzpatrick Skin Score
Fitzpatrick Skin Type I
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Fitzpatrick Skin Score
Fitzpatrick Skin Type II
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Fitzpatrick Skin Score
Fitzpatrick Skin Type III
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Fitzpatrick Skin Score
Fitzpatrick Skin Type IV
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Fitzpatrick Skin Score
Fitzpatrick Skin Type V
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Fitzpatrick Skin Score
Fitzpatrick Skin Type VI
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 MonthsPopulation: 8 subjects did not attend the 3 month follow up, and 2 subjects attended but did not complete their MASI score.
The severity of the melasma is assessed based on a photographic scale. The scale ranges from 0 to 48, with 48 being the most severe. A decrease in the MASI score from the baseline to the follow up corresponds with decreasing severity.
Outcome measures
| Measure |
Laser Treatment
n=5 Participants
Laser treatment added to microdermabrasion and topical lightening agent regimen
Q-Switched Nd:YAG Laser (RevLite): Laser treatment added to a microdermabrasion and topical lightening agent regimen
|
Control Group
n=3 Participants
Lightening cream and microdermabrasion only.
|
|---|---|---|
|
Melasma Area Severity Assessment (MASI) Score Change From Baseline to Follow Up
|
-5.6 score on a scale
Standard Deviation 6.9
|
4.7 score on a scale
Standard Deviation 9.2
|
Adverse Events
Laser Treatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Laser Treatment
n=9 participants at risk
Laser treatment added to microdermabrasion and topical lightening agent regimen
Q-Switched Nd:YAG Laser (RevLite): Laser treatment added to a microdermabrasion and topical lightening agent regimen
|
Control Group
n=9 participants at risk
Microdermabrasion and topical lightening agent regimen only.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Dryness
|
0.00%
0/9 • Adverse Events occurring were captured and followed throughout each patient's duration in the study, approximately 11 months.
Only 1 subject experienced adverse events during this study.
|
11.1%
1/9 • Adverse Events occurring were captured and followed throughout each patient's duration in the study, approximately 11 months.
Only 1 subject experienced adverse events during this study.
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation
|
0.00%
0/9 • Adverse Events occurring were captured and followed throughout each patient's duration in the study, approximately 11 months.
Only 1 subject experienced adverse events during this study.
|
11.1%
1/9 • Adverse Events occurring were captured and followed throughout each patient's duration in the study, approximately 11 months.
Only 1 subject experienced adverse events during this study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The PI cannot disclose confidential or proprietary information until after it becomes generally known or available to the public.
- Publication restrictions are in place
Restriction type: OTHER