Tranexamic Acid vs Fractional CO2 Laser in Post-acne Hyperpigmentation

NCT03765021 | Unknown

• 1 other identifier: Dermatology 9
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Post Inflammatory Hyperpigmentation

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Tranexamic acid injection (Kapron)

EXPERIMENTAL

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

Fractional CO2 laser resurfacing

ACTIVE COMPARATOR

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

Interventions

Tranexamic Acid DRUG

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.

Also known as: Kapron

Tranexamic acid injection (Kapron)

Fractional CO2 laser DEVICE

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.

Fractional CO2 laser resurfacing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Related Publications (1)

• 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.

  PMID: 34414642 DERIVED

MeSH Terms

Conditions

Hyperpigmentation

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Method of randomization: using closed envelopes containing cards with fractional CO2 Rt and fractional CO2 Lt and the patient will draw one of them blindly.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: November 25, 2018
• First Posted: December 5, 2018
• Study Start: December 1, 2018
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: December 5, 2018

Record last verified: 2018-11