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Tranexamic Acid vs. Combination With Fractional Carbon Dioxide Laser in Melasma

Primary Purpose

Melasma

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Fractional CO2 laser
Tranexamic acid intradermal microinjections
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melasma focused on measuring Melasma, Tranexamic acid, Fractional CO2 laser

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with bilateral symmetrical facial melasma

Exclusion Criteria:

  • Pregnancy and lactation.
  • Patients taking oral contraceptive pills or hormonal replacement therapy at the time of the study or during the past 12 months.
  • Concomitant use of anticoagulants.
  • Bleeding disorders.
  • Personal or family history of deep venous thrombosis or thromboembolic events.
  • Scarring and keloid tendency.
  • Active skin infection, active Herpes simplex virus.
  • History of Post-inflammatory hyperpigmentation.
  • History of photosensitivity or photosensitizing medication as sulfonamides tetracycline,retinoids, bleaching creams, peeling and laser two months before the study.
  • Occupational sun exposure.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Fractional CO2 laser combined with Tranexamic acid

    Tranexamic acid alone

    Arm Description

    one side of the face of all participants will be subjected to low power fractional CO2 laser with a power of 12 watts, spacing 800 micrometer (7.3% density), and dwell time 300 microsecond for 3 sessions every 6 weeks. In addition to Tranexamic acid intradermal microinjections using tranexamic acid 500mg/5ml ampoules, the dose of 1ml syringe with 100mg/ml with maximum of 4ml per session, on the 2nd and the 4th week of each laser session. With total treatment time for each patient of 4 months and another month free of sessions for followup.

    the other side of the face of all participants will be subjected Tranexamic acid intradermal microinjections using tranexamic acid 500mg/5ml ampoules, the dose of 1ml syringe with 100mg/ml with maximum of 4ml per session, every 2 weeks for 4 months then another month free of sessions for followup.

    Outcomes

    Primary Outcome Measures

    Melanin and Erythema indices change from baseline
    Comparing the effect of Tranexamic acid intradermal microinjection alone versus its combination with low power fractional CO2 laser in a sequential pattern on melasma improvement by measuring the Melanin and erythema Indices (MI and EI) using reflectance spectrophotometer before starting the study, two and four weeks after the last session.
    Dermoscopic features change from baseline
    Comparing the effect of Tranexamic acid intradermal microinjection alone versus its combination with low power fractional CO2 laser in a sequential pattern on melasma improvement by Dermoscopy before starting the study, two and four weeks after the last session.

    Secondary Outcome Measures

    Full Information

    First Posted
    March 21, 2019
    Last Updated
    March 30, 2019
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03899233
    Brief Title
    Tranexamic Acid vs. Combination With Fractional Carbon Dioxide Laser in Melasma
    Official Title
    Comparing Tranexamic Acid Microinjection Alone Versus Its Combination With Fractional Carbon Dioxide Laser in Melasma Treatment
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 1, 2019 (Anticipated)
    Primary Completion Date
    October 1, 2019 (Anticipated)
    Study Completion Date
    November 1, 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
    The objective of this study is to assess and compare the efficacy of tranexamic acid intradermal microinjection alone versus its combination with low power fractional CO2 laser in a sequential pattern. In all participants one half of the face will be randomly assigned to low power fractional CO2 laser while other side to Tranexamic acid intradermal microinjections on the 1st session. This split face session will be repeated every six weeks for 3 sessions. In addition, Tranexamic acid intradermal microinjections will be applied for full face at the 2nd and 4th week of each split face session. The response will be evaluated by the Melanin and erythema Indices which will be measured using reflectance spectrophotometer, Dermoscopy and photography before starting the study, two and four weeks after the last session. The sessions will take 4 months for each patient and another one month free of sessions for follow up.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Melasma
    Keywords
    Melasma, Tranexamic acid, Fractional CO2 laser

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Model Description
    Each participate will be assigned to both arms (split face manner). One half of the face will be assigned to Tranexamic acid alone and the other side of the face will be assigned to combined Tranexamic acid and Fractional CO2 laser. Both sides of the face will take the same time of treatment and will be assessed at the same time.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    25 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Fractional CO2 laser combined with Tranexamic acid
    Arm Type
    Active Comparator
    Arm Description
    one side of the face of all participants will be subjected to low power fractional CO2 laser with a power of 12 watts, spacing 800 micrometer (7.3% density), and dwell time 300 microsecond for 3 sessions every 6 weeks. In addition to Tranexamic acid intradermal microinjections using tranexamic acid 500mg/5ml ampoules, the dose of 1ml syringe with 100mg/ml with maximum of 4ml per session, on the 2nd and the 4th week of each laser session. With total treatment time for each patient of 4 months and another month free of sessions for followup.
    Arm Title
    Tranexamic acid alone
    Arm Type
    Active Comparator
    Arm Description
    the other side of the face of all participants will be subjected Tranexamic acid intradermal microinjections using tranexamic acid 500mg/5ml ampoules, the dose of 1ml syringe with 100mg/ml with maximum of 4ml per session, every 2 weeks for 4 months then another month free of sessions for followup.
    Intervention Type
    Device
    Intervention Name(s)
    Fractional CO2 laser
    Intervention Description
    Low power fractional CO2 laser with a power of 12 watts, spacing 800 micrometer (7.3% density), and dwell time 300 microsecond
    Intervention Type
    Drug
    Intervention Name(s)
    Tranexamic acid intradermal microinjections
    Intervention Description
    Tranexamic acid 500mg/5ml ampules
    Primary Outcome Measure Information:
    Title
    Melanin and Erythema indices change from baseline
    Description
    Comparing the effect of Tranexamic acid intradermal microinjection alone versus its combination with low power fractional CO2 laser in a sequential pattern on melasma improvement by measuring the Melanin and erythema Indices (MI and EI) using reflectance spectrophotometer before starting the study, two and four weeks after the last session.
    Time Frame
    baseline, 18 weeks and 20 weeks
    Title
    Dermoscopic features change from baseline
    Description
    Comparing the effect of Tranexamic acid intradermal microinjection alone versus its combination with low power fractional CO2 laser in a sequential pattern on melasma improvement by Dermoscopy before starting the study, two and four weeks after the last session.
    Time Frame
    baseline, 18 weeks and 20 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with bilateral symmetrical facial melasma Exclusion Criteria: Pregnancy and lactation. Patients taking oral contraceptive pills or hormonal replacement therapy at the time of the study or during the past 12 months. Concomitant use of anticoagulants. Bleeding disorders. Personal or family history of deep venous thrombosis or thromboembolic events. Scarring and keloid tendency. Active skin infection, active Herpes simplex virus. History of Post-inflammatory hyperpigmentation. History of photosensitivity or photosensitizing medication as sulfonamides tetracycline,retinoids, bleaching creams, peeling and laser two months before the study. Occupational sun exposure.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Eman R Said, MD
    Phone
    +201110066044
    Email
    dremy07@cu.edu.eg
    First Name & Middle Initial & Last Name or Official Title & Degree
    Shereen O Tawfic, MD
    Phone
    +201220085050
    Email
    shereenosamat@yahoo.com

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    30431171
    Citation
    Tawfic SO, Abdel Halim DM, Albarbary A, Abdelhady M. Assessment of combined fractional CO2 and tranexamic acid in melasma treatment. Lasers Surg Med. 2019 Jan;51(1):27-33. doi: 10.1002/lsm.23032. Epub 2018 Nov 15.
    Results Reference
    background
    PubMed Identifier
    20514787
    Citation
    Trelles MA, Velez M, Gold MH. The treatment of melasma with topical creams alone, CO2 fractional ablative resurfacing alone, or a combination of the two: a comparative study. J Drugs Dermatol. 2010 Apr;9(4):315-22.
    Results Reference
    background
    PubMed Identifier
    24858737
    Citation
    Jalaly NY, Valizadeh N, Barikbin B, Yousefi M. Low-power fractional CO(2) laser versus low-fluence Q-switch 1,064 nm Nd:YAG laser for treatment of melasma: a randomized, controlled, split-face study. Am J Clin Dermatol. 2014 Aug;15(4):357-63. doi: 10.1007/s40257-014-0080-x.
    Results Reference
    background
    PubMed Identifier
    29027510
    Citation
    Saki N, Darayesh M, Heiran A. Comparing the efficacy of topical hydroquinone 2% versus intradermal tranexamic acid microinjections in treating melasma: a split-face controlled trial. J Dermatolog Treat. 2018 Jun;29(4):405-410. doi: 10.1080/09546634.2017.1392476. Epub 2017 Nov 9.
    Results Reference
    background

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    Tranexamic Acid vs. Combination With Fractional Carbon Dioxide Laser in Melasma

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