Refractory Mixed Type Melasma
Conditions
Brief summary
The purpose of this study is to evaluate the RevLite laser in the treatment of refractory mixed type melasma.
Interventions
DEVICEQ-Switched Nd:YAG Laser (RevLite)
Laser treatment added to a microdermabrasion and topical lightening agent regimen
DRUGRetin-A and microdermabrasion
Microdermabrasion and topical lightening agent regimen
Sponsors
ConBio, a Cynosure Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 9 |
| Control Group Microdermabrasion and topical lightening agent regimen | 9 |
| Total | 18 |
Baseline characteristics
| Characteristic | Laser Treatment | Control Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 9 Participants | 18 Participants |
| Fitzpatrick Skin Score Fitzpatrick Skin Type I | 0 Participants | 0 Participants | 0 Participants |
| Fitzpatrick Skin Score Fitzpatrick Skin Type II | 0 Participants | 0 Participants | 0 Participants |
| Fitzpatrick Skin Score Fitzpatrick Skin Type III | 3 Participants | 3 Participants | 6 Participants |
| Fitzpatrick Skin Score Fitzpatrick Skin Type IV | 4 Participants | 4 Participants | 8 Participants |
| Fitzpatrick Skin Score Fitzpatrick Skin Type V | 2 Participants | 2 Participants | 4 Participants |
| Fitzpatrick Skin Score Fitzpatrick Skin Type VI | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race/Ethnicity African American | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Asian-American | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Caucasian | 4 Participants | 5 Participants | 9 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Indian | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Spanish/Hispanic | 2 Participants | 2 Participants | 4 Participants |
| Sex: Female, Male Female | 9 Participants | 9 Participants | 18 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 / 9 | 0 / 9 |
| other Total, other adverse events | 0 / 9 | 1 / 9 |
| serious Total, serious adverse events | 0 / 9 | 0 / 9 |
Outcome results
Primary
Melasma Area Severity Assessment (MASI) Score Change From Baseline to Follow Up
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
Population: 8 subjects did not attend the 3 month follow up, and 2 subjects attended but did not complete their MASI score.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Laser Treatment | Melasma Area Severity Assessment (MASI) Score Change From Baseline to Follow Up | -5.6 score on a scale | Standard Deviation 6.9 |
| Control Group | Melasma Area Severity Assessment (MASI) Score Change From Baseline to Follow Up | 4.7 score on a scale | Standard Deviation 9.2 |