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

NCT ID: NCT04170088

Last Updated: 2019-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-01

Study Completion Date

2019-06-30

Brief Summary

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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

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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.

Conditions

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Effect of Drugs Adverse Effects of Medical Drugs

Keywords

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Melasma Tranexamic acid Mesotherapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

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 Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers
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.

Study Groups

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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

Group Type EXPERIMENTAL

Tranexamic Acid

Intervention Type DRUG

Tranexamic acid intradermal injections were used for treatment of melasma

0.9% Normal Saline

Intervention Type DRUG

Normal saline used for comparision of efficacy of tranexamic acid

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

Group Type EXPERIMENTAL

0.9% Normal Saline

Intervention Type DRUG

Normal saline used for comparision of efficacy of tranexamic acid

Interventions

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Tranexamic Acid

Tranexamic acid intradermal injections were used for treatment of melasma

Intervention Type DRUG

0.9% Normal Saline

Normal saline used for comparision of efficacy of tranexamic acid

Intervention Type DRUG

Other Intervention Names

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Normal saline

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Jinnah Postgraduate Medical Centre

OTHER_GOV

Sponsor Role lead

Responsible Party

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Dr Sana Kaleem

Department of Dermatology, SKaleem, FCPS II Postgraduate Trainee

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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rabia ghafoor, FCPS

Role: STUDY_DIRECTOR

Assistant Profesor

Locations

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Jinnah potgraduate Medical Centre ( JINNAH HOPITAL)

Karachi, Sindh, Pakistan

Site Status

Countries

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Pakistan

References

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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.

Reference Type RESULT
PMID: 28726212 (View on PubMed)

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.

Reference Type RESULT
PMID: 25184917 (View on PubMed)

Other Identifiers

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[email protected]

Identifier Type: REGISTRY

Identifier Source: secondary_id

F.2-81/2018-GENL/2522/JPMC

Identifier Type: -

Identifier Source: org_study_id