- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03565341
Efficacy and Safety of PiQo4 Device for Treatment of Melasma
December 25, 2019 updated by: Focus Medical, LLC
Evaluation of the Efficacy and Safety of the PiQo4 Picosecond Laser (PSL) System for the Treatment of Patients With Melasma: A Prospective, Randomized, Split Face Study Comparing the Added Value of 585nm Over 1064nm PSL
Single center, Prospective, Open Label with Split-face Study Design. Face sides will be randomized to receive either 1064nm alone or 1064nm & 585nm combination treatment.
Each subject will receive up to 3 treatments at monthly intervals (±4 days). Follow-up visits will take place at 1, 3, and 6 months following the last treatment.
Study Overview
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New Jersey
-
Hackensack, New Jersey, United States, 07601
- Hackensack University Medical Center - Skin Laser & Surgery Specialists Of NY & NJ
-
-
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
18 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Healthy Female
- Age= 18-75.
- Fitzpatrick skin phototype = II-V
- Melasma severity: diagnosed with mild to severe melasma lesions (MSS≥2)
- Melasma type: Dermal or mixed type melasma, confirmed by Wood's lamp test
- Melasma duration: The subject's melasma has persisted for greater than 6 months
- Melasma previous treatments: has failed to respond to conventional treatment with hydroquinone or other topical lightening agents
- Able to read, understand and provide written Informed Consent.
- Able and willing to comply with the treatment/follow-up schedule and post treatment care
- Agreed to use the same facial skin care products during the clinical trial period (including the follow-up period)
- 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 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 and willingness to allow Focus Medical (the study Sponsor) and Lumenis and the investigators to use de-identified photographs of the treated area for presentation and publication purposes
- (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
Exclusion Criteria:
- Pregnant, intending to become pregnant during the course of study, less than 3 months postpartum or less than 3 months after completion of breastfeeding
- Known hypersensitivity or contraindications to anaesthetic agents including lidocaine and its derivatives
- Participation in a study of another device or drug within three months prior to enrolment or during the study.
- Presence of open wounds or lesions in the area
- Extensive scarring or tattoos in areas to be treated.
- Having other pigmentation disorder
- Having an excessive underlying vascular condition (e.g. dense network of capillaries).
- Suffering from current or history of significant skin conditions in the treated area that could interfere with the evaluation (i.e. infection, dermatitis, or rash on their face) or requires the use of interfering topical or systemic therapy.
- Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning during the study.
- Having a history of diseases stimulated by heat, such as recurrent Herpes Simplex in the treated area, unless treatment is conducted following a prophylactic regimen
- Subjects who are opposed to possible damage to the hair follicles with possible loss of hair in the treatment area
- Laser or medium/deep chemical peel, or surgery, or filler treatments using collagen, hyaluronic acid, or any other material at area of treatment, within 6 months of initial treatment or during the course of the study.
- IPL or superficial chemical peel within the previous 1 month
- Topical therapy with retinoids, imiquimod, 5-fluorouracil, ingenol mebutate, diclofenac, alpha-hydroxy acids, or salicylic acids within the previous 1 month.
- Currently using topical retinoid, hydroquinone or corticosteroid or whitening cream such as alpha arbutin, azelaic acid, kojic acid ascorbic acid or any cosmetics within 2 weeks
- Lightening oral medication (hydroquinone, tranexamic acid), isotretinoid (or retinoid), light-sensitive medication, or steroids in the last 6 months
- History of keloid scarring, hypertrophic scarring, or of abnormal wound healing.
- History of connective tissue diseases such as systemic lupus erythematosus or scleroderma
- Active leukoplakia, eczema, or psoriasis in the treatment area
- History of post inflammatory pigmentary disorders, particularly a tendency for hyper- or hypo-pigmentation.
- History of cutaneous photosensitization, porphyria, and hypersensitivity to porphyrins or photodermatosis.
- Has used photosensitizing drugs (e.g., Declomycin, sulfa antibiotics, phenothiazines, etc.) within a timeframe where photosensitization from these drugs may still be present
- History of skin cancer in the treatment area
- Significant concurrent illness or any disease state that in the opinion of the Investigator would interfere with the treatment or healing process
- History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications.
- Having a known anticoagulative or thromboembolic condition or taking anticoagulation medications one week prior to and during the treatment course (to allow inclusion, temporary cessation of use as per the subject's physician's discretion).
- History of hormonal therapy in the last 3 months (e.g., estrogen, progesterone, or oral contraceptive)
- As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study
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: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Melasma
Treatment of Melasma Using PiQo4 Laser System
|
PiQo4 Laser System for treatment of Melasma
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent of subjects having an improvement of at least 1 point on the MSS or ≥ 50% MASI score improvement on at least one of the face sides at the 1-month follow-up visit.
Time Frame: 1 month follow up
|
The study will be deemed successful if the point estimate of the percent of successful subjects will be at least 50%.
|
1 month follow up
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percent of subjects having an improvement of at least 1 point on the MSS or ≥ 50% MASI score improvement on at least one of the face sides at the 3-month follow-up visit
Time Frame: 3 months follow up
|
3 months follow up
|
Percent of subjects having an improvement of at least 1 point on the MSS or ≥ 50% MASI score improvement on each face side
Time Frame: 6 months follow up
|
6 months follow up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: David J Goldberg, MD, Hackensack University Medical Center - Skin Laser & Surgery Specialists Of NY & NJ
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)
July 2, 2018
Primary Completion (ACTUAL)
August 8, 2019
Study Completion (ACTUAL)
August 8, 2019
Study Registration Dates
First Submitted
June 10, 2018
First Submitted That Met QC Criteria
June 20, 2018
First Posted (ACTUAL)
June 21, 2018
Study Record Updates
Last Update Posted (ACTUAL)
December 27, 2019
Last Update Submitted That Met QC Criteria
December 25, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Focus-PiQo4 Melasma-17-04
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
Yes
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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