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Tranexamic Acid vs Fractional CO2 Laser in Post-acne Hyperpigmentation

Primary Purpose

Post Inflammatory Hyperpigmentation

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Tranexamic Acid
Fractional CO2 laser
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Inflammatory Hyperpigmentation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Tranexamic acid injection (Kapron)

    Fractional CO2 laser resurfacing

    Arm Description

    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 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.

    Outcomes

    Primary Outcome Measures

    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
    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
    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).
    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

    Secondary Outcome Measures

    Full Information

    First Posted
    November 25, 2018
    Last Updated
    December 4, 2018
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03765021
    Brief Title
    Tranexamic Acid vs Fractional CO2 Laser in Post-acne Hyperpigmentation
    Official Title
    Tranexamic Acid Versus Fractional CO2 Laser in Post-inflammatory Hyperpigmentation in Acne Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 2018 (Anticipated)
    Primary Completion Date
    July 2019 (Anticipated)
    Study Completion Date
    July 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Post Inflammatory Hyperpigmentation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Masking Description
    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.
    Allocation
    Randomized
    Enrollment
    25 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Tranexamic acid injection (Kapron)
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Fractional CO2 laser resurfacing
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Tranexamic Acid
    Other Intervention Name(s)
    Kapron
    Intervention Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    Fractional CO2 laser
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Measurement of melanin index to assess change of post-acne hyperpigmentation
    Description
    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
    Time Frame
    3 months
    Title
    Measurement of erythema index to assess change of post-acne hyperpigmentation
    Description
    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
    Time Frame
    3 months
    Title
    Measurement of post-acne hyperpigmentation index to assess change of post-acne hyperpigmentation
    Description
    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).
    Time Frame
    3 months
    Title
    Patient satisfaction score to assess change of post-acne hyperpigmentation
    Description
    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
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    34414642
    Citation
    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.
    Results Reference
    derived

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    Tranexamic Acid vs Fractional CO2 Laser in Post-acne Hyperpigmentation

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