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

NCT05884151 | Completed Phase 1

• 1 other identifier: Cmh abbottabad321
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

Drug: Tranexamic acid

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.

Drug: Platelets rich plasma

Interventions

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

Intralesional tranexamic acid in the treatment of melasma

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.

Intrlesional platelets rich plasma in the treatment of melasma

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \_40 years of age
• suffering from melasma

You may not qualify if:

• pregnancy
• breastfeeding mothers
• allergic to tranexamic acid
• bleeding disorders
• warts or facial eczema

Sponsors & Collaborators

• Combined Military Hospital Abbottabad: lead

Study Sites (3)

Dr sana aslam

Abbottabad, Khyber Pakhtun Khwaa, 22010, Pakistan

Location

Sana aslam

Abbottabad, Khyber Pakhtun Khwa, 22010, Pakistan

Location

Sana aslam

Abbottābād, Khyber Pakhtun Khwa, 22010, Pakistan

Location

MeSH Terms

Conditions

Melanosis

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Hyperpigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: May 16, 2023
• First Posted: June 1, 2023
• Study Start: November 1, 2022
• Primary Completion: April 30, 2023
• Study Completion: April 30, 2023
• Last Updated: June 1, 2023

Record last verified: 2023-05

Locations

PA (3)