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

Melasma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03040089
• Other study ID #: LTN-03
• Status: Completed
• Phase: N/A
• First received: January 24, 2017
• Last updated: January 30, 2017
• Start date: March 9, 2016
• Est. completion date: September 26, 2016

Study information

• Verified date: January 2017
• Source: LUTRONIC Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 26, 2016
• Est. primary completion date: July 15, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 74 Years

Eligibility

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

Related Conditions & MeSH terms

• Melanosis
• Melasma

Intervention

Device:
• PICO+4
picosecond, neodymium-doped yttrium aluminum garnet laser

Drug:
• Neoquine Cream 2%
2% hydroquinone cream

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
LUTRONIC Corporation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success rate of treatment according to RL*I	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.	Baseline, 1 week after final treatment
Secondary	Relative skin lightness using the colorimeter(RL*I)		Baseline, 1 week, 4 weeks, and 12 weeks after the final treatment
Secondary	mMASI (modified Melasma Area Severity Index) evaluation		Baseline, 1 week, 4 weeks, 8 weeks, and 12 weeks after the final treatment
Secondary	Subject satisfaction (5-point scale questionnaires on subject's satisfaction)		1 week and 12 weeks after the final treatment