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The purpose of this study is to evaluate the RevLite laser in the treatment of refractory mixed type melasma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laser treatment | Experimental | Laser treatment and microdermabrasion and topical lightening agent regimen |
|
| Control | Active Comparator | Microdermabrasion and topical lightening agent regimen |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Q-Switched Nd:YAG Laser (RevLite) | Device | Laser treatment added to a microdermabrasion and topical lightening agent regimen |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arielle Kauvar, MD | New York Laser and Skin Care | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York Laser and Skin Care | New York | New York | 10028 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Control Group | Microdermabrasion and skin lightening regimen |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Control Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 8 subjects did not attend the 3 month follow up, and 2 subjects attended but did not complete their MASI score. | Posted | Mean | Standard Deviation | score on a scale | 3 Months |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dryness | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jamie Trimper | Cynosure | 800-886-2966 | jamie.trimper@cynosure.com |
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| ID | Term |
|---|---|
| D014212 | Tretinoin |
| ID | Term |
|---|---|
| D014801 | Vitamin A |
| D012176 | Retinoids |
| D002338 | Carotenoids |
| D011090 | Polyenes |
| D000475 |
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| Retin-A and microdermabrasion | Drug | Microdermabrasion and topical lightening agent regimen |
|
Microdermabrasion and topical lightening agent regimen |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Fitzpatrick Skin Score | The Fitzpatrick Skin Score is used to determine skin color. It is a numerical system that classifies skin into six types (Type I, Type II, Type III, Type IV, Type V and Type VI) based on the numerical score achieved (ranging from 0 to 36). The lower the score (and skin type number), the fairer the skin. The higher the score (and skin type number), the more deeply pigmented the skin is. The scale comes from this source: Gupta, Sharma. Skin typing: Fitzpatrick grading and others. Clinics in Dermatology. 2019;37(5):430-436. doi:10.1016/j.clindermatol.2019.07.010 | Count of Participants | Participants |
|
Lightening cream and microdermabrasion only. |
|
|
| 0 |
| 9 |
| 0 |
| 9 |
| 0 |
| 9 |
| EG001 | Control Group | Microdermabrasion and topical lightening agent regimen only. | 0 | 9 | 0 | 9 | 1 | 9 |
| Hyperpigmentation | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
The PI cannot disclose confidential or proprietary information until after it becomes generally known or available to the public.
| Alkenes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D053138 | Cyclohexenes |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D013729 | Terpenes |
| D004224 | Diterpenes |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |