PigmentationNCT04539561
Evaluation of the Efficacy and Safety of PiQo4 for the Treatment of Hand Pigmentation Using 1064nm PSL and 532nm PSL
A study testing PiQo4 Laser System in people with Pigmentation, run by Focus Medical, LLC at 1 site in United Kingdom.
Trial summary
A total of 20 healthy subjects at a single site, aged 21-70 years old with congenital or acquired challenging/resistant, age/sun-related flat and benign 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
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Sep 2020to Apr 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 21 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy Female/Male.
- Age= 21-70 (Adults).
- Fitzpatrick skin phototype = I-V
- Congenital or acquired benign pigmentation on hands.
- Presence of at least three (3) lesions with similar pigmentation intensity in the treatment area in diameters larger than 2 mm.
- Able to read, understand and provide written Informed Consent.
- 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.
Who cannot join
- History of post inflammatory pigmentary disorders, particularly a tendency for hyper- or hypo-pigmentation.
- Tanning (artificial or natural) 1 month prior first treatment and during the entire study duration including follow-up.
- 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 in treated area with laser or other devices within 12 months of initial treatment or during the course of the study.
Show all 12Show fewer
- 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.
- 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 or suspicious pigmentation in area to be treated.
- Presence of underlying tattoo in the treatment area.
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
"Sk;N" Clinic
London
Firas Al-Niaimi, Dr., +447956147543
About this study
A total of 20 healthy subjects at a single site, aged 21-70 years old with congenital or acquired challenging/resistant, age/sun-related flat and benign 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 hand pigmentation
| Study group | Role | What they receive |
|---|---|---|
| Pigmentation | Experimental | Treatment of Hand Pigmentation 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.
Hands pigmentation change assessed by investigator
Hands pigmentation change assessed by investigator at the 1 month follow up using the 5-point Pigment Improvement Score where score of between 0 and 4 will be assigned (0- No improvement in pigmentation, 1- Trace to mild improvement of some lesions, 2- Moderate response: some lesions lighter, 3- Good response: most lesions much lighter and 4- Excellent response- Most or all lesions much lighter or gone.
Measured: 1 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 posted7 Sep 2020
- Study start24 Sep 2020
- Primary completionApr 2022 (estimated)
- Study completionApr 2022 (estimated)
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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Focus Medical, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04539561
- Sponsor's protocol ID
- Focus-PiQo4 Pigmentation-19-02
- Status last verified
- Mar 2021
- First submitted
- 10 Mar 2020
- Last updated
- 16 Mar 2022
- 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 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Safety of PiQo4 for the Treatment of Hand Pigmentation Using 1064nm PSL and 532nm PSL
- ClinicalTrials.gov ID
- NCT04539561
- Acronym / sponsor ID
- Focus-PiQo4 Pigmentation-19-02
- Conditions
- Pigmentation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Focus Medical, LLCIndustry (pharma, biotech, devices)
- Study start
- 24 Sep 2020 (actual)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 7 Sep 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 20 healthy subjects at a single site, aged 21-70 years old with congenital or acquired challenging/resistant, age/sun-related flat and benign 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 Hand Pigmentation 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 (8 listed)
- Healthy Female/Male.
- Age= 21-70 (Adults).
- Fitzpatrick skin phototype = I-V
- Congenital or acquired benign pigmentation on hands.
- Presence of at least three (3) lesions with similar pigmentation intensity in the treatment area in diameters larger than 2 mm.
Key exclusion criteria (12 listed)
- History of post inflammatory pigmentary disorders, particularly a tendency for hyper- or hypo-pigmentation.
- Tanning (artificial or natural) 1 month prior first treatment and during the entire study duration including follow-up.
- 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 hand pigmentation | Device | Pigmentation |
Primary outcome
Hands pigmentation change assessed by investigator
Time frame: 1 month follow up
Hands pigmentation change assessed by investigator at the 1 month follow up using the 5-point Pigment Improvement Score where score of between 0 and 4 will be assigned (0- No improvement in pigmentation, 1- Trace to mild improvement of some lesions, 2- Moderate response: some lesions lighter, 3- Good response: most lesions much lighter and 4- Excellent response- Most or all lesions much lighter or gone.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2022.
Related trials for Pigmentation
RecruitingPhase 4
Foam Sclerotherapy With or Without Transdermal Laser for Reticular Veins and Telangiectasias
Telangiectasias, Reticular Veins
Active, not recruitingObservational study
Retinal Pigment Epithelium Safety Study For Patients In B4711001
Age Related Macular Degeneration
RecruitingObservational study
National Ophthalmic Genotyping and Phenotyping Network (eyeGENE (Registered Trademark)), Stage 3 - Expansion of DNA and Data Repositories for Rare Inherited Ophthalmic Diseases
Inherited Ophthalmic Diseases, Hypopigmentation Disorder
Not yet recruitingPhase 2/3
Two Trials to Evaluate TEV-53408 in Participants With Non-Segmental Vitiligo
Vitiligo
RecruitingPhase 1/2
Autologous Transplantation of Induced Pluripotent Stem Cell-Derived Retinal Pigment Epithelium for Geographic Atrophy Associated With Age-Related Macular Degeneration
Dry Age-Related Macular Degeneration, Geographic Atrophy
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.
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 Kingdom.
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 8 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 16 Mar 2022. 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 Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Firas Al-Niaimi, MD (+447956147543, Firas55@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hands pigmentation change assessed by investigator (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 16 Mar 2022.