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

Phase 1

Completed

• Conditions: Melasma
• Interventions: Drug: Platelets rich plasma; Drug: Tranexamic acid

• Registration Number: NCT05884151
• Lead Sponsor: Combined Military Hospital Abbottabad

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-01
• Primary Completion: 2023-04-30
• Study Completion: 2023-04-30
• Status Verified: 2023-05
• Study First Submitted: 2023-05-16
• Study First Submitted QC: 2023-05-30
• Last Update Submitted: 2023-05-30
• Study First Posted: 2023-06-01
• Last Update Posted: 2023-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intrlesional platelets rich plasma 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.
Intralesional tranexamic acid in the treatment of melasma	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

Primary Outcome Measures

Name	Time	Method
Melasma severity index	24 weeks	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

Trial Locations

Locations (2)

Dr sana aslam; 🇵🇰 Abbottabad, Khyber Pakhtun Khwaa, Pakistan

Sana aslam; 🇵🇰 Abbottābād, Khyber Pakhtun Khwa, Pakistan