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ABSTRACT Objective: To study the efficacy while comparing Intralesional tranexamic acid Vs Platelets rich plasma (PRP) in treatment of Melasma.
Study design: Randomized-controlled trial (RCT). Study setting and duration: Dept of dermatology, CMH-Abbottabad, Nov-2022 /April-2023.
Methodology: The sample size of 60 patients 20 to 40 years were calculated by using Openepi App. The informed consent was taken. The patients were randomly allocated to two groups: Group A (30 patients injected with Intradermal Tranexamic acid (4mg/ml) and Group B (30 patients treated with PRP (1ml) intra-dermally, every fourth week for up to 12 weeks between both groups). The mMASI scale was used to evaluate all patients. The final evaluation was performed on the 24th week of follow-up. For analysis Statistical Package for the social sciences version-27 was used. To determine statistical significance a paired t-samples test with a p-value of < 0.05 was applied.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intralesional tranexamic acid in the treatment of melasma | Active Comparator | Group A 30 patients treated with Intradermal Tranexamic acid injection (4mg/ml) for preparation an insulin syringe was used with a volume of 1ml containing 0.04 ml of TXA and the reminder being normal saline to ensure 4mg preparation in each insulin syringe |
|
| Intrlesional platelets rich plasma in the treatment of melasma | Active Comparator | Group B 30 patients prescribed with PRP (1ml) intra-dermally PRP was obtained manually by a two-step procedure using a centrifuge machine. First spin was performed at 1500 RPM for 10 minutes. Second spin was performed at 4000 RPM for 10 minutes. Thus, obtaining a two-part plasma. Upper two third was platelet poor plasma and was discarded. Lower one third was platelets rich plasma. Before injection applying 0.1 ml calcium chloride was added for each 1 ml of PRP to activate the platelets. PRP was injected 1 ml by using 30 G needle (insulin syringe) in each cm2 of melasma. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic acid | Drug | Group A 30 patients treated with Intradermal Tranexamic acid injection (4mg/ml) for preparation an insulin syringe was used with a volume of 1ml containing 0.04 ml of TXA and the reminder being normal saline to ensure 4mg preparation in each insulin syringe |
| Measure | Description | Time Frame |
|---|---|---|
| Melasma severity index | Modified melasma area severity score is used to measure effectiveness of both drugs in treatment of melasma Score value ranges from 0-24 . 24 means melasma is more severe | 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr sana aslam | Abbottabad | Khyber Pakhtun Khwaa | 22010 | Pakistan | ||
| Sana aslam |
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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 |
|---|---|
| D014148 | Tranexamic Acid |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Platelets rich plasma | Drug | Group B 30 patients prescribed with PRP (1ml) intra-dermally PRP was obtained manually by a two-step procedure using a centrifuge machine. First spin was performed at 1500 RPM for 10 minutes. Second spin was performed at 4000 RPM for 10 minutes. Thus, obtaining a two-part plasma. Upper two third was platelet poor plasma and was discarded. Lower one third was platelets rich plasma. Before injection applying 0.1 ml calcium chloride was added for each 1 ml of PRP to activate the platelets. PRP was injected 1 ml by using 30 G needle (insulin syringe) in each cm2 of melasma. |
|
| Abbottabad |
| Khyber Pakhtun Khwa |
| 22010 |
| Pakistan |
| Sana aslam | Abbottābād | Khyber Pakhtun Khwa | 22010 | Pakistan |