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

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ClinicalTrials.gov Identifier: NCT03040089
Recruitment Status : Completed
First Posted : February 2, 2017
Last Update Posted : February 2, 2017
Sponsor:
Information provided by (Responsible Party):
LUTRONIC Corporation

Tracking Information
First Submitted Date  ICMJE January 24, 2017
First Posted Date  ICMJE February 2, 2017
Last Update Posted Date February 2, 2017
Actual Study Start Date  ICMJE March 9, 2016
Actual Primary Completion Date July 15, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 30, 2017)
Success rate of treatment according to RL*I [ Time Frame: Baseline, 1 week after final treatment ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 30, 2017)
  • Relative skin lightness using the colorimeter(RL*I) [ Time Frame: Baseline, 1 week, 4 weeks, and 12 weeks after the final treatment ]
  • mMASI (modified Melasma Area Severity Index) evaluation [ Time Frame: Baseline, 1 week, 4 weeks, 8 weeks, and 12 weeks after the final treatment ]
  • Subject satisfaction (5-point scale questionnaires on subject's satisfaction) [ Time Frame: 1 week and 12 weeks after the final treatment ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Picosecond, Neodymium-doped Yttrium Aluminum Garnet Laser Therapy Using 1,064 nm and 595 nm
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Melasma
Intervention  ICMJE
  • Device: PICO+4
    picosecond, neodymium-doped yttrium aluminum garnet laser
  • Drug: Neoquine Cream 2%
    2% hydroquinone cream
Study Arms  ICMJE
  • Experimental: picosecond laser & 2% hydroquinone cream
    PICO+4 laser system and Neoquine Cream 2% (2% hydroquinone cream) for melasma
    Interventions:
    • Device: PICO+4
    • Drug: Neoquine Cream 2%
  • Sham Comparator: 2% hydroquinone cream
    Only Neoquine Cream 2% (2% hydroquinone cream) for melasma
    Intervention: Drug: Neoquine Cream 2%
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 30, 2017)
40
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 26, 2016
Actual Primary Completion Date July 15, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 19 Years to 74 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03040089
Other Study ID Numbers  ICMJE LTN-03
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party LUTRONIC Corporation
Study Sponsor  ICMJE LUTRONIC Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Wonserk Kim Kangbuk Samsung Hospital
PRS Account LUTRONIC Corporation
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP