Tranexamic Acid vs Fractional CO2 Laser in Post-acne Hyperpigmentation

Cairo University (CU)

Status: Unknown

Conditions: Post Inflammatory Hyperpigmentation

Treatments: Drug: Tranexamic Acid; Device: Fractional CO2 laser

Study type: Interventional

Funder types: Other

Identifiers

NCT03765021

Dermatology 9

Details and patient eligibility

About

comparing between the effect of intradermal injection of TXA and low power low density fractional CO2 lasers on post acne hyperpigmentation

Full description

Randomized controlled split-face study. One side of the face will be assigned to TXA intradermal microinjection using Kapron 500mg/5ml ampoules (Amoun Pharmaceutical Company), the dose of 1 ml syringe with 100mg/ml. TXA will be prepared under sterile conditions. Injections will be applied intradermally on hyperpigmented areas at 1cm intervals. The injection will be repeated every two weeks for three months. The other side of the face will be randomly assigned to low power fractional CO2 laser with a power of 12 watts, spacing 700 micrometers (low density), and dwell time 300 microsecond every four weeks for three months.

Enrollment: 25 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Egyptians of both sexes.
• Age > 18.
• Patients who can avoid sun exposure one week after sessions.
• Patients who stopped taking systemic isotretinoin for more than six months.

Exclusion criteria

• Pregnancy and lactation.
• Concomitant use of anticoagulants.
• Bleeding disorders.
• Personal or family history of DVT or thromboembolic events.
• Scarring and keloid tendency.
• Active skin infection, active HSV.
• History of photosensitivity or photosensitizing medication.
• Occupational sun exposure.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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25 participants in 2 patient groups

Tranexamic acid injection (Kapron)

Experimental group

Description:

One side of the face will be assigned to TXA intradermal microinjection using Kapron 500mg/5ml ampoules (Amoun Pharmaceutical Company), the dose of 1 ml syringe with 100mg/ml. TXA will be prepared under sterile conditions. Injections will be applied intradermally on hyperpigmented areas at 1cm intervals. The injection will be repeated every two weeks for three months.

Treatment:

Drug: Tranexamic Acid

Fractional CO2 laser resurfacing

Active Comparator group

Description:

The other side of the face will be randomly assigned to do low power fractional CO2 laser with a power of 12 watts, spacing 700 micrometers (low density), and dwell time 300 microsecond every four weeks for three months.

Treatment:

Device: Fractional CO2 laser