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

NCT ID: NCT03040089

Last Updated: 2017-02-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-09
• Study Completion Date: 2016-09-26

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.

Conditions

Melasma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

picosecond laser & 2% hydroquinone cream

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

Group Type: EXPERIMENTAL

PICO+4

Intervention Type: DEVICE

picosecond, neodymium-doped yttrium aluminum garnet laser

Neoquine Cream 2%

Intervention Type: DRUG

2% hydroquinone cream

2% hydroquinone cream

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

Group Type: SHAM_COMPARATOR

Neoquine Cream 2%

Intervention Type: DRUG

2% hydroquinone cream

Interventions

PICO+4

picosecond, neodymium-doped yttrium aluminum garnet laser

Intervention Type: DEVICE

Neoquine Cream 2%

2% hydroquinone cream

Intervention Type: DRUG

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

LUTRONIC Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wonserk Kim

Role: PRINCIPAL_INVESTIGATOR

Kangbuk Samsung Hospital

Other Identifiers

LTN-03

Identifier Type: -

Identifier Source: org_study_id