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

Primary Purpose

Melasma

Status
Completed
Phase
Phase 1
Locations
Pakistan
Study Type
Interventional
Intervention
Tranexamic acid
Platelets rich plasma
Sponsored by
Combined Military Hospital Abbottabad
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melasma

Eligibility Criteria

20 Years - 40 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Dr sana aslam
  • Sana aslam
  • Sana aslam

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Intralesional tranexamic acid in the treatment of melasma

Intrlesional platelets rich plasma in the treatment of melasma

Arm Description

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 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 16, 2023
Last Updated
May 30, 2023
Sponsor
Combined Military Hospital Abbottabad
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1. Study Identification

Unique Protocol Identification Number
NCT05884151
Brief Title
Comparison of Intralesional Tranexamic Acid and Platelets Rich Plasma in the Treatment of Melasma
Official Title
Comparative Efficacy of Intralesional Tranexamic Acid and Platelets Rich Plasma in the Treatment of Melasma
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
April 30, 2023 (Actual)
Study Completion Date
April 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Combined Military Hospital Abbottabad

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melasma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intralesional tranexamic acid in the treatment of melasma
Arm Type
Active Comparator
Arm Description
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
Arm Title
Intrlesional platelets rich plasma in the treatment of melasma
Arm Type
Active Comparator
Arm Description
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
Intervention Name(s)
Tranexamic acid
Intervention Description
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
Intervention Name(s)
Platelets rich plasma
Intervention Description
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.
Primary Outcome Measure Information:
Title
Melasma severity index
Description
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
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Dr sana aslam
City
Abbottabad
State/Province
Khyber Pakhtun Khwaa
ZIP/Postal Code
22010
Country
Pakistan
Facility Name
Sana aslam
City
Abbottabad
State/Province
Khyber Pakhtun Khwa
ZIP/Postal Code
22010
Country
Pakistan
Facility Name
Sana aslam
City
Abbottābād
State/Province
Khyber Pakhtun Khwa
ZIP/Postal Code
22010
Country
Pakistan

12. IPD Sharing Statement

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

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