Skin RejuvenationNCT03322475
Evaluation of the Efficacy and Safety of PiQo4 for Facial Skin Rejuvenation
A study testing PiQo4 laser system in people with Skin Rejuvenation, run by Focus Medical, LLC at 1 site in United States.
Trial summary
A total of at least 20 healthy subjects at a single site, with at least two facial sub-areas with visible wrinkles with pigmentation and/or acne scars who wish to improve their skin appearance will be enrolled into the study. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Rejuvenation
- 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 States
- Study dates
- 12 Mar 2018to 30 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects must meet all of the following inclusion criteria to be entered into the study:
- Healthy Female/Male.
- Age= 18-70 (Adults).
- Fitzpatrick skin phototype = I-V
- Exhibiting at least two facial sub-areas with visible wrinkles with pigmentation and/or acne scars.
- 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
- Willingness to provide a brief medical history including disclosure of any prescribed or over-the-counter medications taken within the past 6 months.
- 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.
- Daily use of sunscreen for the duration of the study
- 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
- Any of the following will exclude the subject from the study:
- 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.
- Known hypersensitivity or contraindications to anesthetic agents including lidocaine and its derivatives, and Toradol.
- 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.
- History of post inflammatory pigmentary disorders, particularly a tendency for hyper- or hypo-pigmentation.
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- Having Melasma.
- Having multiple dysplastic Nevi in are to be treated.
- Having an excessive underlying vascular conditions (e.g. dense network of capillaries).
- History of keloid scarring or of abnormal wound healing.
- Suffering from current or history of significant skin conditions in the treated area or inflammatory skin conditions.
- 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).
- Having a neurological disorder (including Multiple Sclerosis, Parkinson's disease).
- Having seizure disorder.
- Having fibromyalgia.
- Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning during the study.
- Participation in a study of another device or drug within three months prior to enrolment or during the study.
- 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
- As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.
- Subjects who are opposed to possible damage to the hair follicles with possible loss of hair in the treatment area.
- Received the following treatments in the area of the face to be treated during or within the noted timeframes prior to the study treatment:
- Dermabrasion or chemical peel treatment within 3 months.
- Any devices and/or Botox treatment within 6 months.
- Collagen/fat injections or other methods of augmentation with injected or implanted material in the treated area within 9 months.
- Resurfacing procedure, face lift or eyelid surgery within a year.
- Having a permanent implant in the facial skin area, such as an injected chemical substance.
- Any other surgery in treated area within 9 months of initial treatment or during the course of the study
- Use of retinoids, antioxidants or therapeutic skin nourishing supplements at medicinal concentration within 2 months and oral retinoids within 6 months of the study
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Scripps Clinical Research Services
La Jolla, California, 92037
About this study
A total of at least 20 healthy subjects at a single site, with at least two facial sub-areas with visible wrinkles with pigmentation and/or acne scars who wish to improve their skin appearance will be enrolled into the study. subjects will receive 3 treatments and return to follow-up visits at 1, 3, and 6 months following the last treatment.
- Conditions
- Skin Rejuvenation
- 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
The PiQo4 laser system
| Study group | Role | What they receive |
|---|---|---|
| Facial skin rejuvenation | Experimental | Facial skin rejuvenation 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.
Fitzpatrick Elastosis Score (FES) scale
Fine lines/wrinkles and elastosis improvement will be classified by the Fitzpatrick-Goldman Elastosis and Wrinkles scales: Class I, Class II or Class III.
Measured: Baseline, 1 month follow up
Overall Global Aesthetic Improvement (GAI) Scale
The global aesthetic improvement (GAI) scale will be used by the investigator to grade improvement in the following categories: 1) Fine lines/wrinkles; 2) texture 3) Pigmentation 4) Acne scars. Score 0-Worse, Score 1-No Change, Score 2- Somewhat improved, Score 3- Moderately improved, Score 4-Very Much Improved.
Measured: Baseline, 1 month follow up
Secondary outcomes (1)
Fitzpatrick Elastosis Score (FES) scale
Skin improvement on the FES scale will be classified by the Fitzpatrick-Goldman Elastosis and Wrinkles scales at the 3 month-follow-up visits as compared to baseline.
Classification: Class I, Class II or Class III.
Measured: Baseline, 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 posted26 Oct 2017
- Study start12 Mar 2018
- Primary completion30 Jul 2019 (estimated)
- Study completion30 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin RejuvenationStudies 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
- Investigators
- Edward Ross, MD, Principal investigator, Scripps Clinic Carmel Valley
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03322475
- Sponsor's protocol ID
- Focus-PiQo4 Rejuvenation-17-02
- Status last verified
- Mar 2019
- First submitted
- 24 Oct 2017
- Last updated
- 7 Mar 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 7 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Safety of PiQo4 for Facial Skin Rejuvenation
- ClinicalTrials.gov ID
- NCT03322475
- Acronym / sponsor ID
- Focus-PiQo4 Rejuvenation-17-02
- Conditions
- Skin Rejuvenation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Focus Medical, LLCIndustry (pharma, biotech, devices)
- Study start
- 12 Mar 2018 (actual)
- Primary completion
- 30 Jul 2019 (estimated)
- Study completion
- 30 Aug 2019 (estimated)
- First posted
- 26 Oct 2017 (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 20 healthy subjects at a single site, with at least two facial sub-areas with visible wrinkles with pigmentation and/or acne scars who wish to improve their skin appearance will be enrolled into the study. subjects will receive 3 treatments and return to follow-up visits 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
| Arm | Type | Receives |
|---|---|---|
| Facial skin rejuvenation | Experimental | Device: PiQo4 laser systemFacial skin rejuvenation using PiQo4 laser system |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Healthy Female/Male.
- Age= 18-70 (Adults).
- Fitzpatrick skin phototype = I-V
- Exhibiting at least two facial sub-areas with visible wrinkles with pigmentation and/or acne scars.
- Able to read, understand and provide written Informed Consent.
Key exclusion criteria (29 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
- 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.
- Known hypersensitivity or contraindications to anesthetic agents including lidocaine and its derivatives, and Toradol.
- 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.
- History of post inflammatory pigmentary disorders, particularly a tendency for hyper- or hypo-pigmentation.
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 systemThe PiQo4 laser system | Device | Facial skin rejuvenation |
Primary outcome
Fitzpatrick Elastosis Score (FES) scale
Time frame: Baseline, 1 month follow up
Fine lines/wrinkles and elastosis improvement will be classified by the Fitzpatrick-Goldman Elastosis and Wrinkles scales: Class I, Class II or Class III.
Overall Global Aesthetic Improvement (GAI) Scale
Time frame: Baseline, 1 month follow up
The global aesthetic improvement (GAI) scale will be used by the investigator to grade improvement in the following categories: 1) Fine lines/wrinkles; 2) texture 3) Pigmentation 4) Acne scars. Score 0-Worse, Score 1-No Change, Score 2- Somewhat improved, Score 3- Moderately improved, Score 4-Very Much Improved.
1 secondary outcome
Fitzpatrick Elastosis Score (FES) scale
Time frame: Baseline, 3 month follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 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.
Edward Ross, MD principal investigator
Scripps Clinic Carmel Valley
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 Skin Rejuvenation, 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 11 inclusion and 29 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 7 Mar 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Edward Ross, MD ((858) 764-3023, Olafson.Tierney@scrippshealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fitzpatrick Elastosis Score (FES) scale (time frame: Baseline, 1 month follow up). The study lists 2 primary outcomes in all. 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 7 Mar 2019.