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

NCT03040089 | Completed

• 1 other identifier: LTN-03
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Relative skin lightness using the colorimeter(RL*I)

  Baseline, 1 week, 4 weeks, and 12 weeks after the final treatment

• mMASI (modified Melasma Area Severity Index) evaluation

  Baseline, 1 week, 4 weeks, 8 weeks, and 12 weeks after the final treatment

• Subject satisfaction (5-point scale questionnaires on subject's satisfaction)

  1 week and 12 weeks after the final treatment

Study Arms (2)

picosecond laser & 2% hydroquinone cream

EXPERIMENTAL

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

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

2% hydroquinone cream

SHAM COMPARATOR

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

Drug: Neoquine Cream 2%

Interventions

PICO+4 DEVICE

picosecond, neodymium-doped yttrium aluminum garnet laser

picosecond laser & 2% hydroquinone cream

Neoquine Cream 2% DRUG

2% hydroquinone cream

2% hydroquinone cream; picosecond laser & 2% hydroquinone cream

Eligibility Criteria

• Age: 19 Years - 74 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• LUTRONIC Corporation: lead

MeSH Terms

Conditions

Melanosis

Condition Hierarchy (Ancestors)

Hyperpigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Wonserk Kim

  Kangbuk Samsung Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2017
• First Posted: February 2, 2017
• Study Start: March 9, 2016
• Primary Completion: July 15, 2016
• Study Completion: September 26, 2016
• Last Updated: February 2, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share