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Efficacy and Safety of Picosecond, Neodymium-doped Yttrium Aluminum Garnet Laser Therapy Using 1,064 nm and 595 nm

Primary Purpose

Melasma

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PICO+4
Neoquine Cream 2%
Sponsored by
LUTRONIC Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melasma

Eligibility Criteria

19 Years - 74 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Females between the ages of 19 and 74
  • Has Fitzpatrick Skin Type III-V
  • Diagnosed with moderate to severe (GSS ≧ 2) melasma lesions
  • Agreed to the prohibition of the use of local/systemic corticosteroids or retinoids and other local/systemic lightening medications, and willing to abide by such instructions
  • Agreed to use the same facial skin care products during the clinical trial period (including the follow-up period), and willing to abide by such instructions
  • Agreed to the daily use of an over SPF 50 sunblock on their face during the clinical trial period (including the follow-up period), and willing to abide by such instructions
  • Agreed to have their face photographed

  • (In case of fertile women) Tested negative in the pregnancy test and agreed to use birth control contraceptives during the clinical trial period

    • Oral contraceptives are forbidden as they may influence the results of the clinical study.
  • Agreed not to undergo any other procedure on their face during their participation in the clinical trial
  • Voluntarily agreed to sign the written consent form and willing to follow the instructions of the study protocol

Exclusion Criteria:

  • Participated in another medical device or medication clinical trial in the last 3 months, or planning to participate in another trial during this trial
  • Received a cosmetic treatment such as laser, light therapy, or surgery in their facial area in the last 6 months, or have a history of filler treatments using collagen, hyaluronic acid, or any other material
  • Diagnosed with incurable melisma
  • Has a history of allergic reaction to local anesthesia
  • Has a history of malignant tumors on their face
  • Has skin lesions such as cuts, wounds, or injuries on their face
  • Pregnant or breastfeeding
  • Has an infection, dermatitis, or rash on their face
  • Currently diagnosed with uncontrolled diabetes or a cardiac disorder such as resistant hypertension
  • Currently diagnosed with anticoagulant disease or taking anticoagulants
  • Has a history of keloid scarring, hypertrophic scarring, or abnormal would healing
  • Has a history of immunodeficiency or intake of immunosuppressants
  • Has a history of leukoplakia, eczema, or psoriasis
  • Has a history of connective tissue diseases such as systemic lupus erythematosus or scleroderma
  • Has a history of convulsive disorder caused by light
  • Has a history of diseases irritated by heat on their face (e.g., herpes simplex or herpes zoster)
  • Has a history of radiotherapy or anticancer chemotherapy on their face
  • Has a history of hormonal therapy in the last 3 months (e.g., estrogen, progesterone, or oral contraceptive)
  • Has a history of use of a lightening medication (hydroquinone, tranexamic acid), isotretinoid (or retinoid), light-sensitive medication, or steroids in the last 6 months
  • Has excessive facial tanning
  • Other subject assessed as inadequate for the clinical trial by the investigators

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    picosecond laser & 2% hydroquinone cream

    2% hydroquinone cream

    Arm Description

    PICO+4 laser system and Neoquine Cream 2% (2% hydroquinone cream) for melasma

    Only Neoquine Cream 2% (2% hydroquinone cream) for melasma

    Outcomes

    Primary Outcome Measures

    Success rate of treatment according to RL*I
    The success rate is determined by the change rate (%) of the relative lightness measured before the treatment (day of screening) and 1 week after the final treatment.

    Secondary Outcome Measures

    Relative skin lightness using the colorimeter(RL*I)
    mMASI (modified Melasma Area Severity Index) evaluation
    Subject satisfaction (5-point scale questionnaires on subject's satisfaction)

    Full Information

    First Posted
    January 24, 2017
    Last Updated
    January 30, 2017
    Sponsor
    LUTRONIC Corporation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03040089
    Brief Title
    Efficacy and Safety of Picosecond, Neodymium-doped Yttrium Aluminum Garnet Laser Therapy Using 1,064 nm and 595 nm
    Official Title
    Efficacy and Safety of Picosecond, Neodymium-doped Yttrium Aluminum Garnet Laser Laser Therapy Using 1,064 nm and 595 nm on Patients With Melasma: A Prospective, Multi-center, Split Face, 2% Hydroquinone Cream-controlled Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    March 9, 2016 (Actual)
    Primary Completion Date
    July 15, 2016 (Actual)
    Study Completion Date
    September 26, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    LUTRONIC Corporation

    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
    This is a prospective, multi-center, split-face, controlled clinical trial that aims to investigate the efficacy and safety of picosecond, neodymium-doped yttrium aluminum garnet laser laser therapy on patients with melasma, compared with 2% hydroquinone cream. The trial will be performed by two Korean institutions on 45 subjects.

    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
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    picosecond laser & 2% hydroquinone cream
    Arm Type
    Experimental
    Arm Description
    PICO+4 laser system and Neoquine Cream 2% (2% hydroquinone cream) for melasma
    Arm Title
    2% hydroquinone cream
    Arm Type
    Sham Comparator
    Arm Description
    Only Neoquine Cream 2% (2% hydroquinone cream) for melasma
    Intervention Type
    Device
    Intervention Name(s)
    PICO+4
    Intervention Description
    picosecond, neodymium-doped yttrium aluminum garnet laser
    Intervention Type
    Drug
    Intervention Name(s)
    Neoquine Cream 2%
    Intervention Description
    2% hydroquinone cream
    Primary Outcome Measure Information:
    Title
    Success rate of treatment according to RL*I
    Description
    The success rate is determined by the change rate (%) of the relative lightness measured before the treatment (day of screening) and 1 week after the final treatment.
    Time Frame
    Baseline, 1 week after final treatment
    Secondary Outcome Measure Information:
    Title
    Relative skin lightness using the colorimeter(RL*I)
    Time Frame
    Baseline, 1 week, 4 weeks, and 12 weeks after the final treatment
    Title
    mMASI (modified Melasma Area Severity Index) evaluation
    Time Frame
    Baseline, 1 week, 4 weeks, 8 weeks, and 12 weeks after the final treatment
    Title
    Subject satisfaction (5-point scale questionnaires on subject's satisfaction)
    Time Frame
    1 week and 12 weeks after the final treatment

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    19 Years
    Maximum Age & Unit of Time
    74 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Females between the ages of 19 and 74 Has Fitzpatrick Skin Type III-V Diagnosed with moderate to severe (GSS ≧ 2) melasma lesions Agreed to the prohibition of the use of local/systemic corticosteroids or retinoids and other local/systemic lightening medications, and willing to abide by such instructions Agreed to use the same facial skin care products during the clinical trial period (including the follow-up period), and willing to abide by such instructions Agreed to the daily use of an over SPF 50 sunblock on their face during the clinical trial period (including the follow-up period), and willing to abide by such instructions Agreed to have their face photographed (In case of fertile women) Tested negative in the pregnancy test and agreed to use birth control contraceptives during the clinical trial period Oral contraceptives are forbidden as they may influence the results of the clinical study. Agreed not to undergo any other procedure on their face during their participation in the clinical trial Voluntarily agreed to sign the written consent form and willing to follow the instructions of the study protocol Exclusion Criteria: Participated in another medical device or medication clinical trial in the last 3 months, or planning to participate in another trial during this trial Received a cosmetic treatment such as laser, light therapy, or surgery in their facial area in the last 6 months, or have a history of filler treatments using collagen, hyaluronic acid, or any other material Diagnosed with incurable melisma Has a history of allergic reaction to local anesthesia Has a history of malignant tumors on their face Has skin lesions such as cuts, wounds, or injuries on their face Pregnant or breastfeeding Has an infection, dermatitis, or rash on their face Currently diagnosed with uncontrolled diabetes or a cardiac disorder such as resistant hypertension Currently diagnosed with anticoagulant disease or taking anticoagulants Has a history of keloid scarring, hypertrophic scarring, or abnormal would healing Has a history of immunodeficiency or intake of immunosuppressants Has a history of leukoplakia, eczema, or psoriasis Has a history of connective tissue diseases such as systemic lupus erythematosus or scleroderma Has a history of convulsive disorder caused by light Has a history of diseases irritated by heat on their face (e.g., herpes simplex or herpes zoster) Has a history of radiotherapy or anticancer chemotherapy on their face Has a history of hormonal therapy in the last 3 months (e.g., estrogen, progesterone, or oral contraceptive) Has a history of use of a lightening medication (hydroquinone, tranexamic acid), isotretinoid (or retinoid), light-sensitive medication, or steroids in the last 6 months Has excessive facial tanning Other subject assessed as inadequate for the clinical trial by the investigators
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Wonserk Kim
    Organizational Affiliation
    Kangbuk Samsung Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Efficacy and Safety of Picosecond, Neodymium-doped Yttrium Aluminum Garnet Laser Therapy Using 1,064 nm and 595 nm

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