PigmentationNCT03565146
Evaluation of the Efficacy and Safety of PiQo4 System for the Treatment of Pigmented Lesions
A study testing PiQo4 Laser System in people with Pigmentation, run by Focus Medical, LLC at 1 site in United States.
Trial summary
A total of at least 25 healthy subjects at a single site, aged 21-70 years old with congenital or acquired challenging/resistant, age/sun-related flat and benign facial pigmentation with or without hand pigmentation who wish to improve their skin appearance. Read more about this study
- Who is it for?
- Ages 21 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Pigmentation
- What is being tested?
- PiQo4 Laser System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jun 2018to 5 Jun 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 21 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy Female or Male
- Age= 21-70 (Adults)
- Fitzpatrick skin phototype = I-V
- Congenital or acquired benign pigmentation on face with optional pigmentation on hand.
- Presence of at least 4 lesions of similar pigmentation intensity in the treatment area, in diameters larger than 2 mm
- Able to read, understand and provide written Informed Consent
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- Able and willing to comply with the treatment/follow-up schedule and requirements
- Women of child-bearing potential are required to use a reliable method of birth control (such as an intrauterine device, birth control pills, condom with spermicidal, NuvaRing, partner with vasectomy, Implanon or other FDA-approved devices, or abstinence) during the course of the study
- Willing to have digital photographs taken of the treatment area
- Willing to refrain from using any prescription or over the counter topical creams used for the treatment of pigmentation (e.g., hydroquinone, retinoids, and/or corticosteroids) in the treatment area during the study period.
- Willing to protect from sun exposure and use an approved sunscreen of SPF 30 or higher in the treatment area daily during the entire duration of the study, including the follow-up period.
- Agree not to undergo any other procedure(s) for the treatment of pigmentation or solar lentigines during the study.
Who cannot join
- History of post inflammatory pigmentary disorders, particularly a tendency for hyper- or hypo-pigmentation
- Melasma
- Excessive underlying vascular conditions (e.g. dense network of capillaries)
- Pregnant, intending to become pregnant during the course of study, less than 3 months postpartum or less than 3 months after completion of breastfeeding
- Prior skin laser, light, or other energy device treatment in treated area within 6 months of initial treatment or during the course of the study
- Prior ablative resurfacing procedure or face-lift in treated area with laser or other devices within 12 months of initial treatment or during the course of the study
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- Prior treatment with medium-depth or deeper chemical peels or dermabrasion in treated area within 3 months of initial treatment or during the course of the study
- Prior use of any prescription or over the counter topical creams used for the treatment of pigmentation (e.g., hydroquinone, retinoids, and/or corticosteroids) in the treatment area within 3 months of initial treatment or during the course of the study
- Any other surgery in treated area within 9 months of initial treatment or during the course of the study
- Hypersensitive to light exposure or the use of photosensitive medication for which light exposure is contraindicated
- Multiple dysplastic nevi in area to be treated
- Significant concurrent illness (e.g. uncontrolled diabetes) or any disease state that in the opinion of the Investigator would interfere with the treatment or healing process
- Any dermal/epidermal damage or disorder, mainly vascular or textural lesions, in the treatment area.
- Any underlying tattoo in the treatment area.
- Unable or unlikely to refrain from tanning, including the use of tanning booths, during the course of the study
- Participation in a study of another investigational device or drug involving the same anatomical site within 3 months prior to enrollment or during this evaluation, or if not involving the same anatomical site, as per the Investigator's discretion
- History of keloid or any other type of hypertrophic scar formation or poor wound healing
- Signs and symptoms of hormonal disorders such as Melasma, as per the Investigator's discretion.
- Concurrent inflammatory skin conditions, open laceration, or abrasion of any sort on area to be treated during the course of treatment
- Active Herpes Simplex (perioral or facial) at the time of treatment or having experienced more than three episodes of Herpes Simplex eruption within a year of study enrollment
- Having a bleeding disorder or taking anticoagulation medications, including daily use of aspirin, in a manner which does not allow for a minimum 10 day washout period prior to treatment (as per the discretion of the subject's primary care physician)
- History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or the use of immunosuppressive medications
- Having any form of active cancer at the time of enrollment and during the course of the study or history of skin cancer on the face/hands
- Pigmented lesions in the areas to be treated that are suspicious for pre-malignancy or malignancy and/or are not deemed suitable for phototherapy, as per the Investigator's discretion
- Unable to understand or provide written Informed Consent (e.g. mental incompetence or evidence of active substance abuse)
- Any condition that, in the Investigator's opinion, would make it unsafe (for the subject or for the study personnel) to treat the subject as part of this research study
- If undergoing punch biopsy, allergic to lidocaine or epinephrine
Trial locations and contacts
1 site in 1 country.
About this study
A total of at least 25 healthy subjects at a single site, aged 21-70 years old with congenital or acquired challenging/resistant, age/sun-related flat and benign facial pigmentation with or without hand pigmentation who wish to improve their skin appearance.
- Conditions
- Pigmentation
- Being tested
- PiQo4 Laser System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PiQo4 Laser SystemDevice
PiQo4 Laser System for treatment of pigmented lesions
| Study group | Role | What they receive |
|---|---|---|
| Pigmentation | Experimental | Treatment of Pigmented Lesions Using PiQo4 Laser System Receives: Device: PiQo4 Laser System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pigmentation Improvement Scale
Facial Pigmentation Improvement evaluated by the investigator at the 1 month follow up visit compared to baseline using a 5-point improvement scale where a score of between 0 and 4 will be assigned (0-No improvement; 1- Trace to mild improvement of some lesions; 2- Moderate response: some lesions lighter; 3- Good response: most lesions much lighter; 4 - excellent response: most or all lesions are much lighter or gone)
Measured: 1 month follow up
Secondary outcomes (1)
Pigmentation Improvement Scale
Facial Pigmentation Improvement evaluated by the investigator at the 3 month follow up visit compared to baseline using a 5-point improvement scale where a score of between 0 and 4 will be assigned (0-No improvement; 1- Trace to mild improvement of some lesions; 2- Moderate response: some lesions lighter; 3- Good response: most lesions much lighter; 4 - excellent response: most or all lesions are much lighter or gone)
Measured: 3 month 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 start29 Jun 2018
- Primary completion5 Jun 2019
- Study completion5 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PigmentationStudies 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
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Focus Medical, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel P Friedmann, Principal investigator, Westlake Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03565146
- Sponsor's protocol ID
- Focus-PiQo4 Pigmentation-17-01
- Status last verified
- Jun 2018
- 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 PiQo4 System for the Treatment of Pigmented Lesions
- ClinicalTrials.gov ID
- NCT03565146
- Acronym / sponsor ID
- Focus-PiQo4 Pigmentation-17-01
- Conditions
- Pigmentation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Focus Medical, LLCIndustry (pharma, biotech, devices)
- Study start
- 29 Jun 2018 (actual)
- Primary completion
- 5 Jun 2019 (actual)
- Study completion
- 5 Jun 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.
A total of at least 25 healthy subjects at a single site, aged 21-70 years old with congenital or acquired challenging/resistant, age/sun-related flat and benign facial pigmentation with or without hand pigmentation who wish to improve their skin appearance.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pigmentation | Experimental | Device: PiQo4 Laser SystemTreatment of Pigmented Lesions Using PiQo4 Laser System |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Healthy Female or Male
- Age= 21-70 (Adults)
- Fitzpatrick skin phototype = I-V
- Congenital or acquired benign pigmentation on face with optional pigmentation on hand.
- Presence of at least 4 lesions of similar pigmentation intensity in the treatment area, in diameters larger than 2 mm
Key exclusion criteria (27 listed)
- History of post inflammatory pigmentary disorders, particularly a tendency for hyper- or hypo-pigmentation
- Melasma
- Excessive underlying vascular conditions (e.g. dense network of capillaries)
- Pregnant, intending to become pregnant during the course of study, less than 3 months postpartum or less than 3 months after completion of breastfeeding
- Prior skin laser, light, or other energy device treatment in treated area within 6 months of initial treatment or during the course of the study
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 |
|---|---|---|
| PiQo4 Laser SystemPiQo4 Laser System for treatment of pigmented lesions | Device | Pigmentation |
Primary outcome
Pigmentation Improvement Scale
Time frame: 1 month follow up
Facial Pigmentation Improvement evaluated by the investigator at the 1 month follow up visit compared to baseline using a 5-point improvement scale where a score of between 0 and 4 will be assigned (0-No improvement; 1- Trace to mild improvement of some lesions; 2- Moderate response: some lesions lighter; 3- Good response: most lesions much lighter; 4 - excellent response: most or all lesions are much lighter or gone)
1 secondary outcome
Pigmentation Improvement Scale
Time frame: 3 month 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.
Daniel P Friedmann principal investigator
Westlake Dermatology
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 Laser System in people with Pigmentation, 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 12 inclusion and 27 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?
Pigmentation Improvement Scale (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.