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Evaluation of Laser and Tranexamic Acid in Treatment of Melasma

Primary Purpose

Melasma

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Tranexamic acid
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melasma

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • - Gender: Only female patients.
  • Age: 18-50 years old.
  • Type of melasma: Bilateral symmetrical facial melasma of all types.
  • Fitzpatrick skin phototypes: Types III, IV and V.

Exclusion Criteria:

  • - Pregnancy and lactation.
  • Patients taking oral contraceptive pills, hormonal replacement therapy or isotretinoin at the time of the study or during the past 6 months. Concomitant use of anticoagulants, bleeding disorders.
  • Scarring and keloid tendency, active skin infections, active HSV, and those with facial cancer.
  • History of photosensitivity or photosensitizing medications such as sulfonamides and tetracycline.
  • Previous history of post inflammatory hyperpigmentation.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    Microneedling group A

    Laser group B

    Gel group C

    Arm Description

    Patients will be subjected to the following: Combined laser (power=3.6 mJ) and topical tranexamic acid (TXA) (one finger unit) gel on the right half of the face. Combined microneedling (by dermapen) and topical TXA gel only on the left half. Self application of topical TXA gel (2 finger units) on both sides on daily base.

    Patients will be subjected to the following: Combined laser(power=3.6 mJ) and topical TXA gel (one finger unit) on the right half. Laser (power=3.6 mJ) only on the left one.

    patients will be subjected to: Daily application of topical TXA gel (2 finger units) on both face sides.

    Outcomes

    Primary Outcome Measures

    safety and effectiveness of fractional CO2 laser, microneedling and topical tranexamic acid gel
    the therapeutic effect of combined fractional co2 laser and topical tranexamic acid versus either fractional co2 laser alone, topical TXA alone or combined microneedling and TXA in treatment of melasma.this will be assessed by melasma area and severity index (MASI).

    Secondary Outcome Measures

    accurate outcome of each treatment modality
    every modality's effect will be measured by the histopathological changes by use of fontana asson stain.

    Full Information

    First Posted
    September 9, 2020
    Last Updated
    October 17, 2020
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04599205
    Brief Title
    Evaluation of Laser and Tranexamic Acid in Treatment of Melasma
    Official Title
    Evaluation of Fractional CO2 Laser and Tranexamic Acid in Treatment of Melasma:Clinical,Histopathological and Immunohistochemical Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 2020 (Anticipated)
    Primary Completion Date
    December 2021 (Anticipated)
    Study Completion Date
    December 2022 (Anticipated)

    3. Sponsor/Collaborators

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

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No

    5. Study Description

    Brief Summary
    Melasma Is an acquired, chronic, recurrent, symmetrical hypermelanosis, which is characterized by brown patches of variable darkness on sun exposed areas of the body. It is more common in women. It is common psychologically and emotionally distressing cosmetic problem in affected patients .
    Detailed Description
    Many studies examined multiple treatment options for melasma , but none of them is completely satisfactory with recurrence in most cases. Tranexamic acid is is a relatively new drug for melasma . It is currently used via a spectrum of delivery routes including oral, topical, intradermal, and microneedling . Laser-assisted drug delivery (LADD) is a technique that facilitates the delivery of topical medications . On reviewing the previous literatures, few studies have focused on therapeutic effects of combined laser and TXA (topical and intradermal) in melasma, with variations in parameters of laser, in dose, concentration, form and routes of TXA application; and in follow up duration. These studies revealed variable unproven results, and since melasma is a challenging disease, additional studies are needed to determine the optimal laser parameters and the best absorbable topical TXA formula, ensuring the best efficacy and less complications. To the best of our knowledge, this is the first study that will use topical TXA gel as an additive effect between sessions, and to confirm the effect of laser and TXA by histopathology and immunohistochemistry.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Melasma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Microneedling group A
    Arm Type
    Experimental
    Arm Description
    Patients will be subjected to the following: Combined laser (power=3.6 mJ) and topical tranexamic acid (TXA) (one finger unit) gel on the right half of the face. Combined microneedling (by dermapen) and topical TXA gel only on the left half. Self application of topical TXA gel (2 finger units) on both sides on daily base.
    Arm Title
    Laser group B
    Arm Type
    Experimental
    Arm Description
    Patients will be subjected to the following: Combined laser(power=3.6 mJ) and topical TXA gel (one finger unit) on the right half. Laser (power=3.6 mJ) only on the left one.
    Arm Title
    Gel group C
    Arm Type
    Experimental
    Arm Description
    patients will be subjected to: Daily application of topical TXA gel (2 finger units) on both face sides.
    Intervention Type
    Drug
    Intervention Name(s)
    Tranexamic acid
    Other Intervention Name(s)
    laser, microneedling
    Intervention Description
    fractional co2 laser, microneedling and topical tranexamic acid gel
    Primary Outcome Measure Information:
    Title
    safety and effectiveness of fractional CO2 laser, microneedling and topical tranexamic acid gel
    Description
    the therapeutic effect of combined fractional co2 laser and topical tranexamic acid versus either fractional co2 laser alone, topical TXA alone or combined microneedling and TXA in treatment of melasma.this will be assessed by melasma area and severity index (MASI).
    Time Frame
    2 years
    Secondary Outcome Measure Information:
    Title
    accurate outcome of each treatment modality
    Description
    every modality's effect will be measured by the histopathological changes by use of fontana asson stain.
    Time Frame
    2 years

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: - Gender: Only female patients. Age: 18-50 years old. Type of melasma: Bilateral symmetrical facial melasma of all types. Fitzpatrick skin phototypes: Types III, IV and V. Exclusion Criteria: - Pregnancy and lactation. Patients taking oral contraceptive pills, hormonal replacement therapy or isotretinoin at the time of the study or during the past 6 months. Concomitant use of anticoagulants, bleeding disorders. Scarring and keloid tendency, active skin infections, active HSV, and those with facial cancer. History of photosensitivity or photosensitizing medications such as sulfonamides and tetracycline. Previous history of post inflammatory hyperpigmentation.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    aya H younis, MD
    Phone
    00201098898917
    Email
    aya.h@yahoo.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    EMAN R MOHAMED, MD
    Organizational Affiliation
    assuit university hospital
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Evaluation of Laser and Tranexamic Acid in Treatment of Melasma

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