1064-nm Q-switched Nd:YAG Laser and Intradermal Tranexamic Acid for Melasma

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Split-face Comparison of Low Fluence 1064-nm Q-switched Nd:YAG Laser Plus Vitamin C vs Low Fluence 1064-nm Q-switched Nd:YAG Laser Plus Intradermal Tranexamic Acid Injection for Melasma:a Single Blinded, Randomised Study

Conditions
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Melasma

Intervention / Treatment
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* Procedure: intradermal tranexamic acid
* Device: Nd-YAG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients > 20 years old with refractory melasma to topical treatment Exclusion Criteria: History of keloid, active eczema, active acne in the face, history of facial eczema, photosensitivity, use of isotretinoin in the past 6 months, pregnancy, and high exposure to sunlight or UV light (UVA or UVB)

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nd-YAG<br>ND-YAG only | Device: Nd-YAG<br>* 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)<br>|
| Experimental: Nd-YAG and intradermal tranexamic acid<br>Nd-YAG combine with intradermal tranexamic acid | Procedure: intradermal tranexamic acid<br>* intradermal tranexamic acid injection<br>Device: Nd-YAG<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Melasma area severity index (MASI) |  | 6 months after last treatment | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |