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

Lutronic

Status: Completed

Conditions: Melasma

Treatments: Device: PICO+4; Drug: Neoquine Cream 2%

Study type: Interventional

Funder types: Industry

Identifiers

NCT03040089

LTN-03

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: Female

Ages: 19 to 74 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

picosecond laser & 2% hydroquinone cream

Experimental group

Description:

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

Treatment:

Drug: Neoquine Cream 2%

Device: PICO+4

2% hydroquinone cream

Sham Comparator group

Description:

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

Treatment:

Drug: Neoquine Cream 2%