Tranexamic Acid vs Fractional CO2 Laser in Post-acne Hyperpigmentation

Cairo University25 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Post Inflammatory Hyperpigmentation

Interventions

Tranexamic AcidDRUG

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 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.

Fractional CO2 laserDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Measurement of melanin index to assess change of post-acne hyperpigmentation

the melanin index (MI) average is 1.10 +/-0.29 with higher values showing worse outcome. It will be measured using reflectance spectrophotometer in order to assess the degree of hyperpigmentation

Time frame: 3 months

Measurement of erythema index to assess change of post-acne hyperpigmentation

the erythema index (EI) average is 1.29 +/- 0.38 with higher values showing worse outcome. It will be measured using reflectance spectrophotometer in order to assess the degree of erythema

Time frame: 3 months

Measurement of post-acne hyperpigmentation index to assess change of post-acne hyperpigmentation

the post-acne hyperpigmentation index (PAHPI) ranges from 6-22 with higher values showing worse outcome. It is a summation of three scores (Postinflammatory hyperpigmentation(PIH) lesion size, median lesion intensity compared with surrounding skin and the number of PIH lesions).

Time frame: 3 months

Patient satisfaction score to assess change of post-acne hyperpigmentation

It is a score ranging from 1-4 with improvement 0-25%=1, 26-50%= 2, 51-75%=3 and more than 75%=4 so higher values of patient satisfaction score showing better outcome

Time frame: 3 months

Data from ClinicalTrials.gov

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