Study of Laser Treatment of Melasma
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the RevLite laser in the treatment of refractory mixed type melasma.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Laser treatment Laser treatment and microdermabrasion and topical lightening agent regimen |
Device: Q-Switched Nd:YAG Laser (RevLite)
Laser treatment added to a microdermabrasion and topical lightening agent regimen
Drug: Retin-A and microdermabrasion
Microdermabrasion and topical lightening agent regimen
|
| Active Comparator: Control Microdermabrasion and topical lightening agent regimen |
Drug: Retin-A and microdermabrasion
Microdermabrasion and topical lightening agent regimen
|
Outcome Measures
Primary Outcome Measures
- Melasma Area Severity Assessment (MASI) Score Change From Baseline to Follow Up [3 Months]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Fitzpatrick Skin Type III-VI
-
mixed (epidermal and dermal) melasma diagnosed by Wood's Lamp exam
-
age 18 or older
-
melasma persisting for greater than 6 months that has failed to respond to conventional treatment with hydroquinone or other topical lightening agents
-
written and verbal informed consent
-
willing and able to comply with study instructions and return to the clinic for required visits
Exclusion Criteria:
-
Pregnancy, breastfeeding, taking birth control pills or plans to become pregnant during the study
-
history of cutaneous photosensitization, porphyria, and hypersensitivity to porphyrins or photodermatosis
-
any skin pathology or condition that could interfere with the evaluation or requires the use of interfering topical or systemic therapy
-
uncorrected coagulation defect or is currently using anti-coagulation medication (including but not limited to heavy aspirin therapy)
-
any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study
-
currently enrolled in an investigational drug or device trial, or has received an investigational drug or has been treated with an investigational device within 30 days prior to entering this study
-
inability to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function
-
unreliability for the study (this includes subjects who engage in excessive alcohol intake or drug abuse, or subjects who are unable to return for scheduled follow-up visits)
-
use of photosensitizing drugs within a timeframe where photosensitization from these drugs may still be present
-
need to be exposed to artificial tanning devices or excessive sunlight during the trial
-
Diabetes Type I or II
-
sensitivity to hydroquinone or Retin-A
-
evidence of a compromised immune system or hepatitis
-
use of bleaching creams or retinoids within the last 30 days
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | New York Laser and Skin Care | New York | New York | United States | 10028 |
Sponsors and Collaborators
- ConBio, a Cynosure Company
Investigators
- Principal Investigator: Arielle Kauvar, MD, New York Laser and Skin Care
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- C69-10-M
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Laser Treatment | Control Group |
|---|---|---|
| Arm/Group Description | 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 | Microdermabrasion and skin lightening regimen |
| Period Title: Overall Study | ||
| STARTED | 9 | 9 |
| COMPLETED | 5 | 3 |
| NOT COMPLETED | 4 | 6 |
Baseline Characteristics
| Arm/Group Title | Laser Treatment | Control Group | Total |
|---|---|---|---|
| Arm/Group Description | 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 | Microdermabrasion and topical lightening agent regimen | Total of all reporting groups |
| Overall Participants | 9 | 9 | 18 |
| Age (Count of Participants) | |||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
9
100%
|
9
100%
|
18
100%
|
| >=65 years |
0
0%
|
0
0%
|
0
0%
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
9
100%
|
9
100%
|
18
100%
|
| Male |
0
0%
|
0
0%
|
0
0%
|
| Race/Ethnicity, Customized (Count of Participants) | |||
| Caucasian |
4
44.4%
|
5
55.6%
|
9
50%
|
| Spanish/Hispanic |
2
22.2%
|
2
22.2%
|
4
22.2%
|
| African American |
0
0%
|
2
22.2%
|
2
11.1%
|
| Indian |
2
22.2%
|
0
0%
|
2
11.1%
|
| Asian-American |
1
11.1%
|
0
0%
|
1
5.6%
|
| Fitzpatrick Skin Score (Count of Participants) | |||
| Fitzpatrick Skin Type I |
0
0%
|
0
0%
|
0
0%
|
| Fitzpatrick Skin Type II |
0
0%
|
0
0%
|
0
0%
|
| Fitzpatrick Skin Type III |
3
33.3%
|
3
33.3%
|
6
33.3%
|
| Fitzpatrick Skin Type IV |
4
44.4%
|
4
44.4%
|
8
44.4%
|
| Fitzpatrick Skin Type V |
2
22.2%
|
2
22.2%
|
4
22.2%
|
| Fitzpatrick Skin Type VI |
0
0%
|
0
0%
|
0
0%
|
Outcome Measures
| Title | Melasma Area Severity Assessment (MASI) Score Change From Baseline to Follow Up |
|---|---|
| Description | 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. |
| Time Frame | 3 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| 8 subjects did not attend the 3 month follow up, and 2 subjects attended but did not complete their MASI score. |
| Arm/Group Title | Laser Treatment | Control Group |
|---|---|---|
| Arm/Group Description | 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 | Lightening cream and microdermabrasion only. |
| Measure Participants | 5 | 3 |
| Mean (Standard Deviation) [score on a scale] |
-5.6
(6.9)
|
4.7
(9.2)
|
Adverse Events
| Time Frame | Adverse Events occurring were captured and followed throughout each patient's duration in the study, approximately 11 months. | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | Only 1 subject experienced adverse events during this study. | |||
| Arm/Group Title | Laser Treatment | Control Group | ||
| Arm/Group Description | 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 | Microdermabrasion and topical lightening agent regimen only. | ||
All Cause Mortality |
||||
| Laser Treatment | Control Group | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/9 (0%) | 0/9 (0%) | ||
Serious Adverse Events |
||||
| Laser Treatment | Control Group | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/9 (0%) | 0/9 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Laser Treatment | Control Group | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/9 (0%) | 1/9 (11.1%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Dryness | 0/9 (0%) | 1/9 (11.1%) | ||
| Hyperpigmentation | 0/9 (0%) | 1/9 (11.1%) | ||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The PI cannot disclose confidential or proprietary information until after it becomes generally known or available to the public.
Results Point of Contact
| Name/Title | Jamie Trimper |
|---|---|
| Organization | Cynosure |
| Phone | 800-886-2966 |
| jamie.trimper@cynosure.com |
- C69-10-M