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A Comparative Study for Efficacy and Safety Between 4% Hydroquinone Cream With or Without Fractional Picosecond 1,064 nm Laser for the Treatment of Dermal or Mixed Type Melasma

Primary Purpose

Picoseconds Laser, Melasma

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Fractional Picosecond 1,064 nm laser
4% hydroquinone cream
Sponsored by
Mae Fah Luang University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Picoseconds Laser

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Female with melasma lesion on bilateral sides
  • Age between 18-65 years
  • Dermal or mixed type melasma, confirming by Wood's lamp test
  • Willing to participant in this study and signed in informed consent form

Exclusion Criteria:

  • Pregnancy / lactation
  • Having an activity or working outside the building or unable to avoid heavy UV light
  • Allergic to UV sunscreen, topical anesthetics , topical corticosteroid or hydroquinone Treatment with laser or chemical peeling within 3 months
  • Treatment with Skin Lighting medication / food supplements within 4 weeks
  • Currently use of topical retinoid, hydroquinone or corticosteroid within 4 weeks
  • Use of whitening cream such as alpha arbutin, azelaic acid, kojic acid ascorbic acid or any cosmetics within 2 weeks
  • Uncontrolled medical illness include non-skin cancers, coagulopathy
  • Intra-cardiac device - pacemaker
  • Photosentive conditions such as diabetes, thyroid disease, liver and kidney disease and photosensitive dermatosis
  • Currently taking anticoagulant such as warfarin
  • Active skin infection or acute dermatitis at testes skin sites
  • Unable to follow and comply to the study protocol

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Fractional Picosecond 1,064 nm laser and 4% hydroquinone cream

    4% hydroquinone cream alone

    Arm Description

    Outcomes

    Primary Outcome Measures

    Modified MASI score
    Proportion of subjects with at least 50% MASI score improvement

    Secondary Outcome Measures

    Mexameter Melanin index
    Global satisfaction score by Quartile rating scale
    Quality of life by DLQI

    Full Information

    First Posted
    February 3, 2017
    Last Updated
    February 7, 2017
    Sponsor
    Mae Fah Luang University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03049059
    Brief Title
    A Comparative Study for Efficacy and Safety Between 4% Hydroquinone Cream With or Without Fractional Picosecond 1,064 nm Laser for the Treatment of Dermal or Mixed Type Melasma
    Official Title
    A Comparative Study for Efficacy and Safety Between 4% Hydroquinone Cream With or Without Fractional Picosecond 1,064 nm Laser for the Treatment of Dermal or Mixed Type Melasma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    June 1, 2016 (Actual)
    Primary Completion Date
    December 1, 2016 (Actual)
    Study Completion Date
    February 1, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Mae Fah Luang University Hospital

    4. Oversight

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

    5. Study Description

    Brief Summary
    A Comparative study for Efficacy and Safety Between 4% hydroquinone cream with or without Fractional Picosecond 1,064 nm Laser for the Treatment of Dermal or Mixed Type Melasma
    Detailed Description
    Primary Objective: To compare clinical efficacy by Modified MASI score between Fractional Picosecond 1,064 nm laser and daily application of 4% hydroquinone with 4% hydroquinone alone Secondary objectives To compare the clinical endpoints of Mexameter Melanin Index, brownish spot and Ultraviolet spots by VISIATM complexion analysis, The Antera 3D® imaging technology for pigmentation, quality of life by Dermatology Life Quality Index and patient's satisfaction between Fractional Picosecond 1,064 nm laser and 4% hydroquinone with 4% hydroquinone alone

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Model Description
    Randomized split face
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Fractional Picosecond 1,064 nm laser and 4% hydroquinone cream
    Arm Type
    Experimental
    Arm Title
    4% hydroquinone cream alone
    Arm Type
    Active Comparator
    Intervention Type
    Device
    Intervention Name(s)
    Fractional Picosecond 1,064 nm laser
    Intervention Description
    Fractional Picosecond 1,064 nm laser and daily application with 4% hydroquinone cream
    Intervention Type
    Drug
    Intervention Name(s)
    4% hydroquinone cream
    Primary Outcome Measure Information:
    Title
    Modified MASI score
    Time Frame
    The mean change from the baseline to week-12 visit
    Title
    Proportion of subjects with at least 50% MASI score improvement
    Time Frame
    from baseline to 12-week visit
    Secondary Outcome Measure Information:
    Title
    Mexameter Melanin index
    Time Frame
    baseline, week 4, week 8 and week 12
    Title
    Global satisfaction score by Quartile rating scale
    Time Frame
    week 4, week 8 and week 12
    Title
    Quality of life by DLQI
    Time Frame
    at week 12

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Female with melasma lesion on bilateral sides Age between 18-65 years Dermal or mixed type melasma, confirming by Wood's lamp test Willing to participant in this study and signed in informed consent form Exclusion Criteria: Pregnancy / lactation Having an activity or working outside the building or unable to avoid heavy UV light Allergic to UV sunscreen, topical anesthetics , topical corticosteroid or hydroquinone Treatment with laser or chemical peeling within 3 months Treatment with Skin Lighting medication / food supplements within 4 weeks Currently use of topical retinoid, hydroquinone or corticosteroid within 4 weeks Use of whitening cream such as alpha arbutin, azelaic acid, kojic acid ascorbic acid or any cosmetics within 2 weeks Uncontrolled medical illness include non-skin cancers, coagulopathy Intra-cardiac device - pacemaker Photosentive conditions such as diabetes, thyroid disease, liver and kidney disease and photosensitive dermatosis Currently taking anticoagulant such as warfarin Active skin infection or acute dermatitis at testes skin sites Unable to follow and comply to the study protocol

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    7496671
    Citation
    Ho C, Nguyen Q, Lowe NJ, Griffin ME, Lask G. Laser resurfacing in pigmented skin. Dermatol Surg. 1995 Dec;21(12):1035-7. doi: 10.1111/j.1524-4725.1995.tb00554.x.
    Results Reference
    background
    Citation
    Weiss M, Weiss R, Lorden F, Trageser M, Beasley K. Picosecond laser for reduction of wrinkles: Long term results. Lasers Surg Med 2015; 47(S26): 24 (Abstract #68).
    Results Reference
    background

    Learn more about this trial

    A Comparative Study for Efficacy and Safety Between 4% Hydroquinone Cream With or Without Fractional Picosecond 1,064 nm Laser for the Treatment of Dermal or Mixed Type Melasma

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