Tranexamic Acid vs Fractional CO2 Laser in Post-acne Hyperpigmentation

Post Inflammatory Hyperpigmentation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03765021
• Other study ID #: Dermatology 9
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2018
• Est. completion date: July 2019

Study information

• Verified date: November 2018
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 25
• Est. completion date: July 2019
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hyperpigmentation
• Post Inflammatory Hyperpigmentation

Intervention

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.

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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