Tranexamic Acid vs Fractional CO2 Laser in Post-acne Hyperpigmentation

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

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

Study Overview

• Status: Unknown
• Conditions: Post Inflammatory Hyperpigmentation
• Intervention / Treatment: Drug: Tranexamic Acid; Device: Fractional CO2 laser

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 Type: Interventional
• Enrollment (Anticipated): 25
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tranexamic acid injection (Kapron); 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; 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.; Other Names: Kapron
Active Comparator: Fractional CO2 laser resurfacing; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cairo University

Publications and helpful links

General Publications

• Tawfic SO, Abdel Hay R, Salim H, Elmasry MF. Tranexamic acid versus fractional carbon dioxide laser in post-acne hyperpigmentation. Dermatol Ther. 2021 Nov;34(6):e15103. doi: 10.1111/dth.15103. Epub 2021 Sep 6.

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2018
• Primary Completion (Anticipated): July 1, 2019
• Study Completion (Anticipated): July 1, 2019

Study Registration Dates

• First Submitted: November 25, 2018
• First Submitted That Met QC Criteria: December 4, 2018
• First Posted (Actual): December 5, 2018

Study Record Updates

• Last Update Posted (Actual): December 5, 2018
• Last Update Submitted That Met QC Criteria: December 4, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pigmentation Disorders; Hyperpigmentation; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: Dermatology 9

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No