Evaluation of Laser and Tranexamic Acid in Treatment of Melasma

Study Overview
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Brief Summary
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Melasma Is an acquired, chronic, recurrent, symmetrical hypermelanosis, which is characterized by brown patches of variable darkness on sun exposed areas of the body. It is more common in women. It is common psychologically and emotionally distressing cosmetic problem in affected patients .

Detailed Description
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Many studies examined multiple treatment options for melasma , but none of them is completely satisfactory with recurrence in most cases. Tranexamic acid is is a relatively new drug for melasma . It is currently used via a spectrum of delivery routes including oral, topical, intradermal, and microneedling . Laser-assisted drug delivery (LADD) is a technique that facilitates the delivery of topical medications . On reviewing the previous literatures, few studies have focused on therapeutic effects of combined laser and TXA (topical and intradermal) in melasma, with variations in parameters of laser, in dose, concentration, form and routes of TXA application; and in follow up duration. These studies revealed variable unproven results, and since melasma is a challenging disease, additional studies are needed to determine the optimal laser parameters and the best absorbable topical TXA formula, ensuring the best efficacy and less complications. To the best of our knowledge, this is the first study that will use topical TXA gel as an additive effect between sessions, and to confirm the effect of laser and TXA by histopathology and immunohistochemistry.

Official Title
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Evaluation of Fractional CO2 Laser and Tranexamic Acid in Treatment of Melasma:Clinical,Histopathological and Immunohistochemical Study

Conditions
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Melasma

Intervention / Treatment
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* Drug: Tranexamic acid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Gender: Only female patients. Age: 18-50 years old. Type of melasma: Bilateral symmetrical facial melasma of all types. Fitzpatrick skin phototypes: Types III, IV and V. Exclusion Criteria: - Pregnancy and lactation. Patients taking oral contraceptive pills, hormonal replacement therapy or isotretinoin at the time of the study or during the past 6 months. Concomitant use of anticoagulants, bleeding disorders. Scarring and keloid tendency, active skin infections, active HSV, and those with facial cancer. History of photosensitivity or photosensitizing medications such as sulfonamides and tetracycline. Previous history of post inflammatory hyperpigmentation.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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 |
| --- | --- |
| Experimental: Microneedling group A<br>Patients will be subjected to the following: Combined laser (power=3.6 mJ) and topical tranexamic acid (TXA) (one finger unit) gel on the right half of the face. Combined microneedling (by dermapen) and topical TXA gel only on the left half. Self application of topical TXA gel (2 finger units) on both sides on daily base. | Drug: Tranexamic acid<br>* fractional co2 laser, microneedling and topical tranexamic acid gel<br>* Other names: microneedling;|
| Experimental: Laser group B<br>Patients will be subjected to the following: Combined laser(power=3.6 mJ) and topical TXA gel (one finger unit) on the right half. Laser (power=3.6 mJ) only on the left one. | Drug: Tranexamic acid<br>* fractional co2 laser, microneedling and topical tranexamic acid gel<br>* Other names: microneedling;|
| Experimental: Gel group C<br>patients will be subjected to: Daily application of topical TXA gel (2 finger units) on both face sides. | Drug: Tranexamic acid<br>* fractional co2 laser, microneedling and topical tranexamic acid gel<br>* Other names: microneedling;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety and effectiveness of fractional CO2 laser, microneedling and topical tranexamic acid gel | the therapeutic effect of combined fractional co2 laser and topical tranexamic acid versus either fractional co2 laser alone, topical TXA alone or combined microneedling and TXA in treatment of melasma.this will be assessed by melasma area and severity index (MASI). | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| accurate outcome of each treatment modality | every modality's effect will be measured by the histopathological changes by use of fontana asson stain. | 2 years |