Tranexamic Acid vs Fractional CO2 Laser in Post-acne Hyperpigmentation

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

Detailed Description
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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.

Official Title
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Tranexamic Acid Versus Fractional CO2 Laser in Post-inflammatory Hyperpigmentation in Acne Patients

Conditions
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Post Inflammatory Hyperpigmentation

Intervention / Treatment
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* Drug: Tranexamic Acid
* Device: Fractional CO2 laser


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tranexamic acid injection (Kapron)<br>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. | Drug: Tranexamic Acid<br>* 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.<br>* Other names: Kapron;|
| Active Comparator: Fractional CO2 laser resurfacing<br>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. | Device: Fractional CO2 laser<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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). | 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 | 3 months |