Tranexamic Acid vs Fractional CO2 Laser in Post-acne Hyperpigmentation

Not Applicable

• Conditions: Post Inflammatory Hyperpigmentation
• Interventions: Device: Fractional CO2 laser; Drug: Tranexamic Acid

• Registration Number: NCT03765021
• Lead Sponsor: Cairo University

Brief Summary

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

Detailed 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.

Study Timeline

• Status Verified: 2018-11
• Study First Submitted: 2018-11-25
• Study Start: 2018-12
• Study First Submitted QC: 2018-12-04
• Last Update Submitted: 2018-12-04
• Study First Posted: 2018-12-05
• Last Update Posted: 2018-12-05
• Primary Completion: 2019-07
• Study Completion: 2019-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 25

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fractional CO2 laser resurfacing	Fractional CO2 laser	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.
Tranexamic acid injection (Kapron)	Tranexamic Acid	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.

Primary Outcome Measures

Name	Time	Method
Measurement of melanin index to assess change of post-acne hyperpigmentation	3 months	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
Measurement of erythema index to assess change of post-acne hyperpigmentation	3 months	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
Measurement of post-acne hyperpigmentation index to assess change of post-acne hyperpigmentation	3 months	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).
Patient satisfaction score to assess change of post-acne hyperpigmentation	3 months	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