Optic IconOptic Logo
|
SearchCollectionsBenchmarks
Clinical trial

Comparative Efficacy of Intralesional Tranexamic Acid and Platelets Rich Plasma in the Treatment of Melasma

ID
Name
Cmh abbottabad321
Description
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.
Trial arms
Trial start
2022-11-01
Estimated PCD
2023-04-30
Trial end
2023-04-30
Status
Completed
Phase
Early phase I
Treatment
Tranexamic acid
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
Arms:
Intralesional tranexamic acid in the treatment of melasma
Platelets rich plasma
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.
Arms:
Intrlesional platelets rich plasma in the treatment of melasma
Size
60
Primary endpoint
Melasma severity index
24 weeks
Eligibility criteria
Inclusion Criteria: * 20_40 years of age * suffering from melasma Exclusion Criteria: * pregnancy * breastfeeding mothers * allergic to tranexamic acid * bleeding disorders * warts or facial eczema
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 60, 'type': 'ACTUAL'}}
Updated at
2023-06-01

1 organization

2 products

1 indication

Organization
Combined Military Hospital Abbottabad
Product
Tranexamic acid
Indication
Melasma
Product
Platelets rich plasma