Comparison of Efficacy of Tranexamic Acid Mesotherapy Versus 0.9% Normal Saline for Melasma

December 13, 2019 updated by: Dr Sana Kaleem, Jinnah Postgraduate Medical Centre

Comparison of Efficacy of Tranexamic Acid Mesotherapy Versus 0.9% Normal Saline for Melasma; a Split Face Study in Tertiary Care Hospital of Karachi

It is a randomized controlled trial in which investigators determine the efficacy of tranexamic acid (TA) by mesotherapy in comparison to normal saline on participants having Melasma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In this prospective single blind split face controlled trial.Total 30 patients referred to Dermatology Ward were selected. At first, patients were examined under wood lamp for determination of melasma type (epidermal, dermal). Then, patients underwent Tranexamic acid microinjections with a concentration of TA 4 mg/ml with 0.9 % normal saline on their left half of the face and only 0.9%normal saline on their right half of the face, with mesotherapy technique. This procedure was done total of six times with 2-week intervals. Participants were assessed by Hemi Modified Melasma Area and Severity Scoring (mMASI) at start and end of the study for each half of face. Statistical Package for Social Sciences (SPSS) , version 23 was used for analysis. P value < 0.01 was taken significant.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 75510
        • Jinnah potgraduate Medical Centre ( JINNAH HOPITAL)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • informed consent
  • age between 18 to 55 years
  • bilateral symmetrical mild to severe melasma

Exclusion Criteria:

  • pregnancy and lactation
  • history of taken any topical treatment for melasma in previous 1 month
  • history of bleeding disorders
  • concomitant use of anticoagulants,
  • any known drug allergy especially to the study drug,
  • having associated medical illnesses.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tranexamic acid

Left side of face of each participant was selected for intradermal Tranexamic acid injections.

generic name : Tranexamic acid Dose : 4mg / ml tranexamc acid diluted with 0.9 % normal saline Frequency : every 2 weekly total 6 doses. Duration : 6 months
Drug: Tranexamic Acid
Tranexamic acid intradermal injections were used for treatment of melasma
Other Names:
  • Normal saline
Drug: 0.9% Normal Saline
Normal saline used for comparision of efficacy of tranexamic acid
Experimental: 0.9% Normal saline
Right side of face of each participant was selected for intradermal normal saline injections generic name : Normal Saline Dose : 0.9 % Normal Saline Dose : Frequency : every 2 weekly total 6 doses. Duration : 6 months
Drug: 0.9% Normal Saline
Normal saline used for comparision of efficacy of tranexamic acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in HEMI-Modified Melasma Area and Severity Index (mMASI)
Time Frame: 10 months

Calculation of Hemi mMASI score is performed by rating darkness and area of involvement of 3 areas of the each half of face. These figures are then inserted into an equation, resulting in the final Hemi mMASI score for both halves of face. Equation : forehead (0.15×D×A) + malar ( 0.30×D×A) + chin ( 0.05×D×A) The mean value of the data obtained from each half of the face was calculated and the mean percentage change was compared. Hemi-MASI score was used because of the study design of split-face, and it was calculated based on the percentage of the involved area Improvement was considered when there was reduction in mean hemi modified MASI score at both sides of face. Higher score was considered as worse and low score was considered as good in improvement of melasma.

At each follow-up visit, adverse events were also evaluated. Patients were asked to reports side effects such as erythema, burning, swelling, and change in menstrual cycle during and after treatment.
10 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jinnah Postgraduate Medical Centre

Investigators

  • Study Director: rabia ghafoor, FCPS, Assistant Profesor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2018

Primary Completion (Actual)

May 1, 2019

Study Completion (Actual)

June 30, 2019

Study Registration Dates

First Submitted

November 17, 2019

First Submitted That Met QC Criteria

November 17, 2019

First Posted (Actual)

November 20, 2019

Study Record Updates

Last Update Posted (Actual)

December 17, 2019

Last Update Submitted That Met QC Criteria

December 13, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F.2-81/2018-GENL/2522/JPMC
  • sana.dec04@hotmail.com (Registry Identifier: JinnaH Postgraduate Medical Centre)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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