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

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

Sponsors

Lead Sponsor: Jinnah Postgraduate Medical Centre

Source Jinnah Postgraduate Medical Centre
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.

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.

Overall Status Completed
Start Date September 1, 2018
Completion Date June 30, 2019
Primary Completion Date May 1, 2019
Phase Phase 2/Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in HEMI-Modified Melasma Area and Severity Index (mMASI) 10 months
Enrollment 30
Condition
Intervention

Intervention Type: Drug

Intervention Name: Tranexamic Acid

Description: Tranexamic acid intradermal injections were used for treatment of melasma

Arm Group Label: Tranexamic acid

Other Name: Normal saline

Intervention Type: Drug

Intervention Name: 0.9% Normal Saline

Description: Normal saline used for comparision of efficacy of tranexamic acid

Eligibility

Criteria:

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: 50 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
rabia ghafoor, FCPS Study Director Assistant Profesor
Location
Facility: Jinnah potgraduate Medical Centre ( JINNAH HOPITAL)
Location Countries

Pakistan

Verification Date

November 2019

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Jinnah Postgraduate Medical Centre

Investigator Full Name: Dr Sana Kaleem

Investigator Title: Department of Dermatology, SKaleem, FCPS II Postgraduate Trainee

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Tranexamic acid

Type: Experimental

Description: 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

Label: 0.9% Normal saline

Type: Experimental

Description: 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

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Single Group Assignment

Intervention Model Description: 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

Primary Purpose: Treatment

Masking: Double (Participant, Care Provider)

Masking Description: 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.

Source: ClinicalTrials.gov