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

Effect of Drugs Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04170088
• Other study ID #: F.2-81/2018-GENL/2522/JPMC
• Secondary ID: sana.dec04@hotma
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: September 1, 2018
• Est. completion date: June 30, 2019

Study information

• Verified date: November 2019
• Source: Jinnah Postgraduate Medical Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 30, 2019
• Est. primary completion date: May 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adverse Effects of Medical Drugs
• Effect of Drugs
• Melanosis

Intervention

Drug:
• Tranexamic Acid
Tranexamic acid intradermal injections were used for treatment of melasma
• 0.9% Normal Saline
Normal saline used for comparision of efficacy of tranexamic acid

Locations

Country	Name	City	State
Pakistan	Jinnah potgraduate Medical Centre ( JINNAH HOPITAL)	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Jinnah Postgraduate Medical Centre

Country where clinical trial is conducted

Pakistan, 

References & Publications (2)

Handel AC, Miot LD, Miot HA. Melasma: a clinical and epidemiological review. An Bras Dermatol. 2014 Sep-Oct;89(5):771-82. Review. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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