- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03040089
Efficacy and Safety of Picosecond, Neodymium-doped Yttrium Aluminum Garnet Laser Therapy Using 1,064 nm and 595 nm
January 30, 2017 updated by: LUTRONIC Corporation
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
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
17 years to 72 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: picosecond laser & 2% hydroquinone cream
PICO+4 laser system and Neoquine Cream 2% (2% hydroquinone cream) for melasma
|
picosecond, neodymium-doped yttrium aluminum garnet laser
2% hydroquinone cream
|
Sham Comparator: 2% hydroquinone cream
Only Neoquine Cream 2% (2% hydroquinone cream) for melasma
|
2% hydroquinone cream
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline, 1 week after final treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Relative skin lightness using the colorimeter(RL*I)
Time Frame: Baseline, 1 week, 4 weeks, and 12 weeks after the final treatment
|
Baseline, 1 week, 4 weeks, and 12 weeks after the final treatment
|
mMASI (modified Melasma Area Severity Index) evaluation
Time Frame: Baseline, 1 week, 4 weeks, 8 weeks, and 12 weeks after the final treatment
|
Baseline, 1 week, 4 weeks, 8 weeks, and 12 weeks after the final treatment
|
Subject satisfaction (5-point scale questionnaires on subject's satisfaction)
Time Frame: 1 week and 12 weeks after the final treatment
|
1 week and 12 weeks after the final treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Wonserk Kim, Kangbuk Samsung Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 9, 2016
Primary Completion (Actual)
July 15, 2016
Study Completion (Actual)
September 26, 2016
Study Registration Dates
First Submitted
January 24, 2017
First Submitted That Met QC Criteria
January 30, 2017
First Posted (Estimate)
February 2, 2017
Study Record Updates
Last Update Posted (Estimate)
February 2, 2017
Last Update Submitted That Met QC Criteria
January 30, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LTN-03
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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