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1064-nm Q-switched Nd:YAG Laser and Intradermal Tranexamic Acid for Melasma

Primary Purpose

Melasma

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
intradermal tranexamic acid
Nd-YAG
Sponsored by
Taipei Medical University WanFang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melasma

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients > 20 years old with refractory melasma to topical treatment

Exclusion Criteria:

  • History of keloid, active eczema, active acne in the face, history of facial eczema, photosensitivity, use of isotretinoin in the past 6 months, pregnancy, and high exposure to sunlight or UV light (UVA or UVB)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Nd-YAG

    Nd-YAG and intradermal tranexamic acid

    Arm Description

    ND-YAG only

    Nd-YAG combine with intradermal tranexamic acid

    Outcomes

    Primary Outcome Measures

    Melasma area severity index (MASI)

    Secondary Outcome Measures

    Quality of life by MELASQOL scale
    Improvement by patient's global assessment (PGA),
    Patient's satisfaction (VAS)
    Improvement by physician's global assessment (PhGA)

    Full Information

    First Posted
    December 22, 2016
    Last Updated
    December 29, 2016
    Sponsor
    Taipei Medical University WanFang Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03008655
    Brief Title
    1064-nm Q-switched Nd:YAG Laser and Intradermal Tranexamic Acid for Melasma
    Official Title
    A Split-face Comparison of Low Fluence 1064-nm Q-switched Nd:YAG Laser Plus Vitamin C vs Low Fluence 1064-nm Q-switched Nd:YAG Laser Plus Intradermal Tranexamic Acid Injection for Melasma:a Single Blinded, Randomised Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2017 (undefined)
    Primary Completion Date
    December 2017 (Anticipated)
    Study Completion Date
    December 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Taipei Medical University WanFang Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    BACKGROUND: Melasma is a chronic, often relapsing skin disorder, with poor long-term results from all current therapies.Q switched 1064nm Nd:YAG laser and intradermal tranexamic acid both showed efficacy on the treatment of melasma. However, no combination therapy of both be reported. OBJECTIVES: To compare the efficacy of low influence Q switched 1064nm Nd:YAG laser and low influence Q switched 1064nm Nd:YAG laser combined with intradermal tranexamic acid injection for melasma.
    Detailed Description
    METHODS: Twenty patients with melasma were included in a randomized controlled observer-blinded study with split-face design. Each side of the face was randomly allocated to either six session at two-week interval of low influence 1064 Nd:YAG laser (6 mm spot size, energy fluence 1.2 - 1.4 J/cm 2 at 10 Hz) or low influence 1064nm Nd:YAG laser combined with intradermal tranexamic acid injection.Complication Improvement of melasma was assessed by Melasma area severity index (MASI),physician's global assessment (PhGA), MELASQOL scale, patient's global assessment (PGA), and patient's satisfaction at baseline,6th week,10th week after first treatment and 3 months, and 6 months after last treatment.

    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
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Nd-YAG
    Arm Type
    Active Comparator
    Arm Description
    ND-YAG only
    Arm Title
    Nd-YAG and intradermal tranexamic acid
    Arm Type
    Experimental
    Arm Description
    Nd-YAG combine with intradermal tranexamic acid
    Intervention Type
    Procedure
    Intervention Name(s)
    intradermal tranexamic acid
    Intervention Description
    intradermal tranexamic acid injection
    Intervention Type
    Device
    Intervention Name(s)
    Nd-YAG
    Intervention Description
    six session at two-week interval of low influence 1064 Nd:YAG laser (6 mm spot size, energy fluence 1.2 - 1.4 J/cm 2 at 10 Hz)
    Primary Outcome Measure Information:
    Title
    Melasma area severity index (MASI)
    Time Frame
    6 months after last treatment
    Secondary Outcome Measure Information:
    Title
    Quality of life by MELASQOL scale
    Time Frame
    6th week,10th week after first treatment and 3 months, and 6 months after last treatment
    Title
    Improvement by patient's global assessment (PGA),
    Time Frame
    6th week,10th week after first treatment and 3 months, and 6 months after last treatment
    Title
    Patient's satisfaction (VAS)
    Time Frame
    6th week,10th week after first treatment and 3 months, and 6 months after last treatment
    Title
    Improvement by physician's global assessment (PhGA)
    Time Frame
    6th week,10th week after first treatment and 3 months, and 6 months after last treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: patients > 20 years old with refractory melasma to topical treatment Exclusion Criteria: History of keloid, active eczema, active acne in the face, history of facial eczema, photosensitivity, use of isotretinoin in the past 6 months, pregnancy, and high exposure to sunlight or UV light (UVA or UVB)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yu Chen Huang, MD
    Phone
    886970746772
    Email
    dhist2002@yahoo.com.tw
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yu Chen Huang, MD
    Organizational Affiliation
    Taipei Medical University WanFang Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    1064-nm Q-switched Nd:YAG Laser and Intradermal Tranexamic Acid for Melasma

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