Combined Q-switched Nd:YAG Laser and Platelet Rich Plasma Versus Q- Switched Nd:YAG Laser Alone in Melasma

Study Overview
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Brief Summary
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Melasma is a common, acquired, esthetically disfiguring hypermelanosis of the face. Melasma is considered a disappointing challenge when treatment options are addressed. Diverse treatment modalities such as retinoic acid, hypo-pigmenting agents like hydroquinone, azelaic acid, and kojic acid, chemical peels, microdermabrasion, and lasers have been tried for the treatment of melasma. There is no universally proven therapy that induces and maintains remission of the condition. Q-switched: Nd YAG laser toning and platelet rich plasma (PRP) are promising treatments for melasma.The aim of this work is evaluate the efficacy and safety of combined PRP and Q-switched: NdYAG laser in the treatment of melasma using clinical assessment, in addition to assessment of Melanin Index and Erythema Index.

Official Title
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Combined Q-switched Nd:YAG Laser and Platelet Rich Plasma Versus Q- Switched Nd:YAG Laser Alone in the Treatment of Melasma: A Split Face Study.

Conditions
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Hyperpigmentation, Melasma, PRP, Lasers

Intervention / Treatment
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* Other: Q-switched nd:YAG laser toning


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with bilateral nearly symmetric melasma on the face. Exclusion Criteria: Patients receiving systemic or topical or laser treatment relevant to melasma within three months before enrollment into the study. Use of oral or injectable contraceptives or hormone replacement therapy during treatment or 12 months before Patients active skin infections and active HSV History of hypertrophic scars or keloids. Patients with hypercoagulable state or bleeding diatheses Pregnant and lactating females. History of liver diseases Intake of systemic chemotherapy, corticosteroids, antiplatelets or anticoagulants

Ages Eligible for Study
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Minimum Age: 18 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PRP Injection<br>Half of the face | Other: Q-switched nd:YAG laser toning<br>* Q-switched nd:YAG laser toning for melasma.<br>|
| Placebo Comparator: Saline injection<br>Other half of the face | Other: Q-switched nd:YAG laser toning<br>* Q-switched nd:YAG laser toning for melasma.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemi-Melasma Area and Severity Index (MASI) score | Hemi-Melasma Area and Severity Index(MASI) score for Pigmentation, and Area of involvement. The minimum value is 0 and the maximum value is 12. Higher scores mean a worse outcome. | 2 months after final treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Melanin Index | Objective assessment of melanin index using colorimeter apparatus. The minimum value is 0. No maximum value. Higher scores mean a worse outcome. | 2 months after final treatment | 
| Erythema Index | Objective assessment of erythema index using colorimeter apparatus. The minimum value is 0. No maximum value. Higher scores mean a worse outcome. | 2 months after final treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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laser toning, Hemi-MASI, Colorimeter, Erythema Index, Melanin Index