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

Sponsor

Combined Military Hospital Abbottabad (Other)

Overall Status

Completed

CT.gov ID

NCT05884151

Collaborator

(none)

Enrollment

Locations

Arms

5.9

Actual Duration (Months)

Patients Per Site

3.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Melasma	Drug: Tranexamic acid Drug: Platelets rich plasma	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 1, 2022

Actual Primary Completion Date :

Apr 30, 2023

Actual Study Completion Date :

Apr 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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	Drug: 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
Active Comparator: 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.	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.

Arm

Intervention/Treatment

Active Comparator: 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

Drug: Tranexamic acid

Active Comparator: 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.

Drug: Platelets rich plasma

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dr sana aslam	Abbottabad	Khyber Pakhtun Khwaa	Pakistan	22010
2	Sana aslam	Abbottabad	Khyber Pakhtun Khwa	Pakistan	22010
3	Sana aslam	Abbottābād	Khyber Pakhtun Khwa	Pakistan	22010

Sponsors and Collaborators

Combined Military Hospital Abbottabad

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dr sana aslam, Principal investigator, Combined Military Hospital Abbottabad

ClinicalTrials.gov Identifier:

NCT05884151

Other Study ID Numbers:

Cmh abbottabad321

First Posted:

Jun 1, 2023

Last Update Posted:

Jun 1, 2023

Last Verified:

May 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Melanosis

Tranexamic Acid

Study Results

No Results Posted as of Jun 1, 2023