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BACKGROUND: Melasma is a chronic, often relapsing skin disorder, with poor long-term results from all current therapies.Q switched 1064nm Nd:YAG laser and intradermal tranexamic acid both showed efficacy on the treatment of melasma. However, no combination therapy of both be reported.
OBJECTIVES: To compare the efficacy of low influence Q switched 1064nm Nd:YAG laser and low influence Q switched 1064nm Nd:YAG laser combined with intradermal tranexamic acid injection for melasma.
METHODS: Twenty patients with melasma were included in a randomized controlled observer-blinded study with split-face design. Each side of the face was randomly allocated to either six session at two-week interval of low influence 1064 Nd:YAG laser (6 mm spot size, energy fluence 1.2 - 1.4 J/cm 2 at 10 Hz) or low influence 1064nm Nd:YAG laser combined with intradermal tranexamic acid injection.Complication Improvement of melasma was assessed by Melasma area severity index (MASI),physician's global assessment (PhGA), MELASQOL scale, patient's global assessment (PGA), and patient's satisfaction at baseline,6th week,10th week after first treatment and 3 months, and 6 months after last treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nd-YAG | Active Comparator | ND-YAG only |
|
| Nd-YAG and intradermal tranexamic acid | Experimental | Nd-YAG combine with intradermal tranexamic acid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intradermal tranexamic acid | Procedure | intradermal tranexamic acid injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Melasma area severity index (MASI) | 6 months after last treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life by MELASQOL scale | 6th week,10th week after first treatment and 3 months, and 6 months after last treatment | |
| Improvement by patient's global assessment (PGA), | 6th week,10th week after first treatment and 3 months, and 6 months after last treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yu Chen Huang, MD | Contact | 886970746772 | dhist2002@yahoo.com.tw |
| Name | Affiliation | Role |
|---|---|---|
| Yu Chen Huang, MD | Taipei Medical University WanFang Hospital | Principal Investigator |
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| 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 |
|---|---|
| D053844 | Lasers, Solid-State |
| ID | Term |
|---|---|
| D007834 | Lasers |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
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| Nd-YAG | Device | six session at two-week interval of low influence 1064 Nd:YAG laser (6 mm spot size, energy fluence 1.2 - 1.4 J/cm 2 at 10 Hz) |
|
| Patient's satisfaction (VAS) | 6th week,10th week after first treatment and 3 months, and 6 months after last treatment |
| Improvement by physician's global assessment (PhGA) | 6th week,10th week after first treatment and 3 months, and 6 months after last treatment |