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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

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.

Condition or disease Intervention/treatment Phase
Melasma Device: PICO+4 Drug: Neoquine Cream 2% Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : March 9, 2016
Actual Primary Completion Date : July 15, 2016
Actual Study Completion Date : September 26, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: picosecond laser & 2% hydroquinone cream
PICO+4 laser system and Neoquine Cream 2% (2% hydroquinone cream) for melasma
Device: PICO+4
picosecond, neodymium-doped yttrium aluminum garnet laser

Drug: Neoquine Cream 2%
2% hydroquinone cream

Sham Comparator: 2% hydroquinone cream
Only Neoquine Cream 2% (2% hydroquinone cream) for melasma
Drug: Neoquine Cream 2%
2% hydroquinone cream




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Relative skin lightness using the colorimeter(RL*I) [ Time Frame: Baseline, 1 week, 4 weeks, and 12 weeks after the final treatment ]
  2. mMASI (modified Melasma Area Severity Index) evaluation [ Time Frame: Baseline, 1 week, 4 weeks, 8 weeks, and 12 weeks after the final treatment ]
  3. Subject satisfaction (5-point scale questionnaires on subject's satisfaction) [ Time Frame: 1 week and 12 weeks after the final treatment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03040089


Sponsors and Collaborators
LUTRONIC Corporation
Investigators
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Principal Investigator: Wonserk Kim Kangbuk Samsung Hospital
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Responsible Party: LUTRONIC Corporation
ClinicalTrials.gov Identifier: NCT03040089    
Other Study ID Numbers: LTN-03
First Posted: February 2, 2017    Key Record Dates
Last Update Posted: February 2, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Melanosis
Hyperpigmentation
Pigmentation Disorders
Skin Diseases