POHNCT04214873
Evaluation of the Effectiveness of the PiQo4 System for Reduction of Infra-orbital Pigmentation
A study testing PiQo4 Laser System in people with POH, run by Focus Medical, LLC at 1 site in United States.
Trial summary
A total of 10 healthy subjects at a single site, aged 18-65 years old and Fitzpatrick skin type I-IV with mild to moderate infra-orbital hyperpigmentation on the background of epidermal and/or dermal pigmentation that wish to improve their POH Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- POH
- 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
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jan 2020to 20 Jan 2022
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Females or males
- Age 18-65
- Fitzpatrick skin types I-IV
- POH on the background of epidermal and/or dermal pigmentation
- POH severity - mild to moderate
- 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 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
- Women of childrearing potential (not postmenopausal [no menstrual cycle for at least 12 months], without an uterus and/or both ovaries, or has had a bilateral tubal ligation)
- (In case of women of childbearing potential) Tested negative in the pregnancy test and agreed to use birth control measures during the clinical trial period including use of contraceptives (see list below) IUD, Double-Barrier Method, Vasectomized Partner, No Heterosexual Intercourse, etc
- Agreed not to undergo any other procedure on their face during their participation in the clinical trial
Who cannot join
- Pregnant or breastfeeding
- Inability to comply with all study protocols and regulations
- Participation in a study of another device or drug
- Heavy smokers and/or drinkers (those who smoke 25 or more cigarettes a day and/or ⩾8 drinks a week for women, and ⩾15 for men)
- Application of any energy device treatment to the infraorbital region within 3 months
- Application of any dermal filler to the infraorbital region within 6 months
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- Facial resurfacing, deep chemical peels, or taking oral retinoids within 6 months
- Microdermabrasion (light or medium skin peel) treatment within 30 days
- Chemical peel, systemic steroids, non-ablative laser, light, or radiofrequency treatment within 3 months
- Use of topical lightening agents or retinoids within 14 days
- Any planned surgical intervention to the face for the duration of the trial
- Use of Latisse, Revitalash, or other lash enhancement stimulators as well as Bimatoprost in the previous 1 month
- Presence of open wounds, lesions, or scarring in the area
- Very thin skin (skin that tears, bruises, or breaks easily)
- 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 (HSV, HZO) in the treated area, unless treatment is conducted following a prophylactic regimen
- History of keloid scarring, hypertrophic scarring, or of abnormal wound healing.
- History of connective tissue diseases such as systemic lupus erythematosus or scleroderma
- 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
- Change of contraceptives dosing in the past 3 months
- Medical disorders such as thyroid or kidney diseases
- Significant concurrent illness or any disease state that in the opinion of the Investigator would interfere with the treatment or healing process
- 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
Cosmetic Laser Dermatology, A West Dermatology Company
San Diego, California, 92121
About this study
Official title: A Pilot Study to Evaluate the Effectiveness of the PiQo4 Picosecond Laser (PSL) System for Reduction of Infra-orbital Pigmentation
A total of 10 healthy subjects at a single site, aged 18-65 years old and Fitzpatrick skin type I-IV with mild to moderate infra-orbital hyperpigmentation on the background of epidermal and/or dermal pigmentation that wish to improve their POH
- Conditions
- POH
- 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 POH
| Study group | Role | What they receive |
|---|---|---|
| POH | Experimental | Treatment of POH 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.
Change in POH severity
POH improvement of at least 1 point evaluated by the investigator at the 3-month follow up compared to baseline using the POH severity in comparison to surrounding skin scale where score of between 0 and 4 will be assigned (0-Normal (Skin color comparable to other facial skin areas); 1- Trace (Faint pigmentation of infraorbital fold (bilateral)); 2- Mild (Pigmentation more pronounced); 3- Moderate (Deep dark colour, all four lids involved): ; 4 - Marked (Grade 3 + pigmentation spreading beyond infraorbital fold)
Measured: 3 month follow up
Secondary outcomes (1)
Aesthetic improvement
Aesthetic improvement evaluated by the investigator at the 3-month follow up compared to baseline using a 5-point improvement scale (GAIS) where a score of between 0 and 4 will be assigned (0-Worse (The appearance is worse than the original condition.); 1- No Change (The appearance is essentially the same as the original condition); 2- Improved (Obvious improvement in appearance from initial condition, but a touch-up or re-treatment is indicated.); 3- Much improved (Marked improvement in appearance from initial condition, but not completely optimal. A touch-up would slightly improve the result.); 4 - Very much improved (Optimal result)
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 posted2 Jan 2020
- Study start6 Jan 2020
- Primary completion20 Jan 2022
- Study completion20 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for POHStudies 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
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Focus Medical, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04214873
- Sponsor's protocol ID
- Focus-PiQo4 POH-19-03
- Status last verified
- Jan 2022
- First submitted
- 25 Dec 2019
- Last updated
- 3 Oct 2023
- 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 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate the Effectiveness of the PiQo4 Picosecond Laser (PSL) System for Reduction of Infra-orbital Pigmentation
- ClinicalTrials.gov ID
- NCT04214873
- Acronym / sponsor ID
- Focus-PiQo4 POH-19-03
- Conditions
- POH
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Focus Medical, LLCIndustry (pharma, biotech, devices)
- Study start
- 6 Jan 2020 (actual)
- Primary completion
- 20 Jan 2022 (actual)
- Study completion
- 20 Jan 2022 (actual)
- First posted
- 2 Jan 2020 (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 10 healthy subjects at a single site, aged 18-65 years old and Fitzpatrick skin type I-IV with mild to moderate infra-orbital hyperpigmentation on the background of epidermal and/or dermal pigmentation that wish to improve their POH
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| POH | Experimental | Device: PiQo4 Laser SystemTreatment of POH Using PiQo4 Laser System |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Females or males
- Age 18-65
- Fitzpatrick skin types I-IV
- POH on the background of epidermal and/or dermal pigmentation
- POH severity - mild to moderate
Key exclusion criteria (27 listed)
- Pregnant or breastfeeding
- Inability to comply with all study protocols and regulations
- Participation in a study of another device or drug
- Heavy smokers and/or drinkers (those who smoke 25 or more cigarettes a day and/or ⩾8 drinks a week for women, and ⩾15 for men)
- Application of any energy device treatment to the infraorbital region within 3 months
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 POH | Device | POH |
Primary outcome
Change in POH severity
Time frame: 3 month follow up
POH improvement of at least 1 point evaluated by the investigator at the 3-month follow up compared to baseline using the POH severity in comparison to surrounding skin scale where score of between 0 and 4 will be assigned (0-Normal (Skin color comparable to other facial skin areas); 1- Trace (Faint pigmentation of infraorbital fold (bilateral)); 2- Mild (Pigmentation more pronounced); 3- Moderate (Deep dark colour, all four lids involved): ; 4 - Marked (Grade 3 + pigmentation spreading beyond infraorbital fold)
1 secondary outcome
Aesthetic improvement
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 3 Oct 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 POH, 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 14 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 3 Oct 2023. 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?
Change in POH severity (time frame: 3 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 3 Oct 2023.