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

NCT ID: NCT05884151

Last Updated: 2023-06-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-01
• Study Completion Date: 2023-04-30

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.

Conditions

Melasma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intralesional tranexamic acid in the treatment of melasma

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

Group Type: ACTIVE_COMPARATOR

Tranexamic acid

Intervention Type: 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

Intrlesional platelets rich plasma in the treatment of melasma

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.

Group Type: ACTIVE_COMPARATOR

Platelets rich plasma

Intervention Type: 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.

Interventions

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

Intervention Type: DRUG

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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Combined Military Hospital Abbottabad

OTHER

Sponsor Role: lead

Responsible Party

Dr sana aslam

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Dr sana aslam

Abbottabad, Khyber Pakhtun Khwaa, Pakistan

Sana aslam

Abbottabad, Khyber Pakhtun Khwa, Pakistan

Sana aslam

Abbottābād, Khyber Pakhtun Khwa, Pakistan

Countries

Pakistan

Other Identifiers

Cmh abbottabad321

Identifier Type: -

Identifier Source: org_study_id