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A Comparative study for Efficacy and Safety Between 4% hydroquinone cream with or without Fractional Picosecond 1,064 nm Laser for the Treatment of Dermal or Mixed Type Melasma
Primary Objective:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fractional Picosecond 1,064 nm laser and 4% hydroquinone cream | Experimental |
| |
| 4% hydroquinone cream alone | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fractional Picosecond 1,064 nm laser | Device | Fractional Picosecond 1,064 nm laser and daily application with 4% hydroquinone cream |
|
| Measure | Description | Time Frame |
|---|---|---|
| Modified MASI score | The mean change from the baseline to week-12 visit | |
| Proportion of subjects with at least 50% MASI score improvement | from baseline to 12-week visit |
| Measure | Description | Time Frame |
|---|---|---|
| Mexameter Melanin index | baseline, week 4, week 8 and week 12 | |
| Global satisfaction score by Quartile rating scale | week 4, week 8 and week 12 | |
| Quality of life by DLQI |
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Inclusion Criteria:
Exclusion Criteria:
Female
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7496671 | Background | Ho C, Nguyen Q, Lowe NJ, Griffin ME, Lask G. Laser resurfacing in pigmented skin. Dermatol Surg. 1995 Dec;21(12):1035-7. doi: 10.1111/j.1524-4725.1995.tb00554.x. | |
| Background | Weiss M, Weiss R, Lorden F, Trageser M, Beasley K. Picosecond laser for reduction of wrinkles: Long term results. Lasers Surg Med 2015; 47(S26): 24 (Abstract #68). |
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Randomized split face
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| 4% hydroquinone cream | Drug |
|
| at week 12 |
| ID | Term |
|---|---|
| D008548 | Melanosis |
| ID | Term |
|---|---|
| D017495 | Hyperpigmentation |
| D010859 | Pigmentation Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D007834 | Lasers |
| ID | Term |
|---|---|
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
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