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

Cairo University (CU)

Status and phase: Unknown; Phase 4

Conditions: Melasma

Treatments: Device: Fractional CO2 laser; Drug: Tranexamic acid intradermal microinjections

Study type: Interventional

Funder types: Other

Identifiers

NCT03899233

Melasma treatment

Details and patient eligibility

About

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.

Enrollment: 25 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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25 participants in 2 patient groups

Fractional CO2 laser combined with Tranexamic acid

Active Comparator group

Description:

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.

Treatment:

Drug: Tranexamic acid intradermal microinjections

Device: Fractional CO2 laser

Tranexamic acid alone

Active Comparator group

Description:

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.

Treatment:

Drug: Tranexamic acid intradermal microinjections