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

NCT04170088 | Completed Phase 2 DMC FDA Drug

• 2 other identifiers: F.2-81/2018-GENL/2522/JPMCsana.dec04@hotmail.com
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Effect of Drugs; Adverse Effects of Medical Drugs

Keywords

Melasma; Tranexamic acid; Mesotherapy

Outcome Measures

Primary Outcomes (1)

• Change in HEMI-Modified Melasma Area and Severity Index (mMASI)

  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

Study Arms (2)

Tranexamic acid

EXPERIMENTAL

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; Drug: 0.9% Normal Saline

0.9% Normal saline

EXPERIMENTAL

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

Interventions

Tranexamic Acid DRUG

Tranexamic acid intradermal injections were used for treatment of melasma

Also known as: Normal saline

Tranexamic acid

0.9% Normal Saline DRUG

Normal saline used for comparision of efficacy of tranexamic acid

0.9% Normal saline; Tranexamic acid

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jinnah Postgraduate Medical Centre: lead

Study Sites (1)

Jinnah potgraduate Medical Centre ( JINNAH HOPITAL)

Karachi, Sindh, 75510, Pakistan

Location

Related Publications (2)

• Ogbechie-Godec OA, Elbuluk N. Melasma: an Up-to-Date Comprehensive Review. Dermatol Ther (Heidelb). 2017 Sep;7(3):305-318. doi: 10.1007/s13555-017-0194-1. Epub 2017 Jul 19.

  PMID: 28726212 RESULT

• Handel AC, Miot LD, Miot HA. Melasma: a clinical and epidemiological review. An Bras Dermatol. 2014 Sep-Oct;89(5):771-82. doi: 10.1590/abd1806-4841.20143063.

  PMID: 25184917 RESULT

MeSH Terms

Conditions

Melanosis

Interventions

Tranexamic Acid; Saline Solution

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• rabia ghafoor, FCPS

  Assistant Profesor

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Participant do not know about the split face study. Their one side was injected by tranexamic acid diluted in normal saline while other side was injected with simple normal saline.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Dermatology, SKaleem, FCPS II Postgraduate Trainee

Model Details: individual patients were selected in study . To control over confounding factors two sides of same patient were used parallel for intradermal injection ( Mesotherapy) of tranexamic acid and with normal saline

Study Record Dates

• First Submitted: November 17, 2019
• First Posted: November 20, 2019
• Study Start: September 1, 2018
• Primary Completion: May 1, 2019
• Study Completion: June 30, 2019
• Last Updated: December 17, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)