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

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

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.

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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 ]

Eligibility Criteria

• 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

Contacts and Locations

Sponsors and Collaborators

LUTRONIC Corporation

Investigators

• Principal Investigator: Wonserk Kim; Kangbuk Samsung Hospital

More Information

• Responsible Party: LUTRONIC Corporation
• ClinicalTrials.gov Identifier: NCT03040089
• Other Study ID Numbers: LTN-03
• First Posted: February 2, 2017
• Last Update Posted: February 2, 2017
• Last Verified: January 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Melanosis; Hyperpigmentation; Pigmentation Disorders; Skin Diseases