MelasmaNCT03565341
Efficacy and Safety of PiQo4 Device for Treatment of Melasma
A study testing PiQo4 in people with Melasma, run by Focus Medical, LLC at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Melasma
- What is being tested?
- PiQo4
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jul 2018to 8 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Hackensack University Medical Center - Skin Laser & Surgery Specialists Of NY & NJ
Hackensack, New Jersey, 07601
About this study
Official title: 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.
- Conditions
- Melasma
- Being tested
- PiQo4
- Medical subject headings
- Melanosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PiQo4Device
PiQo4 Laser System for treatment of Melasma
| Study group | Role | What they receive |
|---|---|---|
| Melasma | Experimental | Treatment of Melasma Using PiQo4 Laser System Receives: Device: PiQo4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
The study will be deemed successful if the point estimate of the percent of successful subjects will be at least 50%.
Measured: 1 month follow up
Secondary outcomes (2)
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
Measured: 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
Measured: 6 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2018
- Study start2 Jul 2018
- Primary completion8 Aug 2019
- Study completion8 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelasmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Face sides will be randomized to receive either 1064nm alone or 1064nm \& 585nm combination treatment
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Focus Medical, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David J Goldberg, MD, Principal investigator, Hackensack University Medical Center - Skin Laser & Surgery Specialists Of NY & NJ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03565341
- Sponsor's protocol ID
- Focus-PiQo4 Melasma-17-04
- Status last verified
- Feb 2019
- First submitted
- 10 Jun 2018
- Last updated
- 27 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03565341
- Acronym / sponsor ID
- Focus-PiQo4 Melasma-17-04
- Conditions
- Melasma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Focus Medical, LLCIndustry (pharma, biotech, devices)
- Study start
- 2 Jul 2018 (actual)
- Primary completion
- 8 Aug 2019 (actual)
- Study completion
- 8 Aug 2019 (actual)
- First posted
- 21 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Face sides will be randomized to receive either 1064nm alone or 1064nm \& 585nm combination treatment
| Arm | Type | Receives |
|---|---|---|
| Melasma | Experimental | Device: PiQo4Treatment of Melasma Using PiQo4 Laser System |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (28 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PiQo4PiQo4 Laser System for treatment of Melasma | Device | Melasma |
Primary outcome
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%.
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David J Goldberg, MD principal investigator
Hackensack University Medical Center - Skin Laser & Surgery Specialists Of NY & NJ
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PiQo4 in people with Melasma, run by Focus Medical, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2019.