Tranexamic Acid vs. Combination With Fractional Carbon Dioxide Laser in Melasma

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

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-01

Study Completion Date

2019-11-01

Brief Summary

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The objective of this study is to assess and compare the efficacy of tranexamic acid intradermal microinjection alone versus its combination with low power fractional CO2 laser in a sequential pattern.

In all participants one half of the face will be randomly assigned to low power fractional CO2 laser while other side to Tranexamic acid intradermal microinjections on the 1st session. This split face session will be repeated every six weeks for 3 sessions.

In addition, Tranexamic acid intradermal microinjections will be applied for full face at the 2nd and 4th week of each split face session.

The response will be evaluated by the Melanin and erythema Indices which will be measured using reflectance spectrophotometer, Dermoscopy and photography before starting the study, two and four weeks after the last session. The sessions will take 4 months for each patient and another one month free of sessions for follow up.

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Detailed Description

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Conditions

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Melasma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Each participate will be assigned to both arms (split face manner). One half of the face will be assigned to Tranexamic acid alone and the other side of the face will be assigned to combined Tranexamic acid and Fractional CO2 laser. Both sides of the face will take the same time of treatment and will be assessed at the same time.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Fractional CO2 laser combined with Tranexamic acid

one side of the face of all participants will be subjected to low power fractional CO2 laser with a power of 12 watts, spacing 800 micrometer (7.3% density), and dwell time 300 microsecond for 3 sessions every 6 weeks. In addition to Tranexamic acid intradermal microinjections using tranexamic acid 500mg/5ml ampoules, the dose of 1ml syringe with 100mg/ml with maximum of 4ml per session, on the 2nd and the 4th week of each laser session. With total treatment time for each patient of 4 months and another month free of sessions for followup.

Group Type ACTIVE_COMPARATOR

Fractional CO2 laser

Intervention Type DEVICE

Low power fractional CO2 laser with a power of 12 watts, spacing 800 micrometer (7.3% density), and dwell time 300 microsecond

Tranexamic acid intradermal microinjections

Intervention Type DRUG

Tranexamic acid 500mg/5ml ampules

Tranexamic acid alone

the other side of the face of all participants will be subjected Tranexamic acid intradermal microinjections using tranexamic acid 500mg/5ml ampoules, the dose of 1ml syringe with 100mg/ml with maximum of 4ml per session, every 2 weeks for 4 months then another month free of sessions for followup.

Group Type ACTIVE_COMPARATOR

Tranexamic acid intradermal microinjections

Intervention Type DRUG

Tranexamic acid 500mg/5ml ampules

Interventions

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Fractional CO2 laser

Low power fractional CO2 laser with a power of 12 watts, spacing 800 micrometer (7.3% density), and dwell time 300 microsecond

Intervention Type DEVICE

Tranexamic acid intradermal microinjections

Tranexamic acid 500mg/5ml ampules

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with bilateral symmetrical facial melasma

Exclusion Criteria

* Pregnancy and lactation.
* Patients taking oral contraceptive pills or hormonal replacement therapy at the time of the study or during the past 12 months.
* Concomitant use of anticoagulants.
* Bleeding disorders.
* Personal or family history of deep venous thrombosis or thromboembolic events.
* Scarring and keloid tendency.
* Active skin infection, active Herpes simplex virus.
* History of Post-inflammatory hyperpigmentation.
* History of photosensitivity or photosensitizing medication as sulfonamides tetracycline,retinoids, bleaching creams, peeling and laser two months before the study.
* Occupational sun exposure.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No