Skin LaxityNCT03969485
Hybrid Fractional Laser for Treatment of Off Face Body Skin Quality
A study testing Hybrid Fractional Laser in people with Skin Laxity, run by Sciton at 1 site in United States.
Trial summary
To demonstrate effectiveness of hybrid fractional laser for the treatment of poor skin quality on the decolletage, back of the hands and lower legs Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Laxity
- What is being tested?
- Hybrid Fractional Laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Apr 2019to 12 Oct 2020
- 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 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male/female subjects between 40 to 65 years of age inclusive
- Fitzpatrick skin type I-III
- Non-smokers or have not smoked (including vaping) within the past 14 days from the screening visit
- Has poor skin texture
- Has mild thin skin
- Has some level of dyschromia on the treatment area as assessed by the Investigator
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- Can read, understand and sign informed consent form (English only)
- Has indicated willingness to participate in the study by signing an informed consent form
- Agrees to adhere to the treatment and follow-up schedule and post treatment care instructions
Who cannot join
- Fitzpatrick skin type IV-VI
- Has tanned within the past 30 days or is unable or unlikely to refrain from tanning, including the use of tanning booths, tanning spray or cream
- Has tattoos, dysplastic nevi on the treatment area
- Is pregnant and/or lactating
- History or current photosensitivity
- History or current use of medication with photosensitizing properties within past 6 months
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- History or current of chronic reoccurring skin disease or disorder affecting treatment area
- History or current cancer of any type
- Has signs of actinic bronzing
- Has open lacerations, and abrasions on the treatment area
- History of keloid formation, or hypertrophic scar formation, or poor wound healing
- History of bleeding disorder, or is currently taking anticoagulation medications
- Has significant concurrent illnesses (controlled or uncontrolled), such as diabetes, lupus, epilepsy, or cardiac disorders, which might be aggravated as a result of treatment
- Has participated in any clinical trial involving an investigational drug, device or cosmetic product or procedure within the past 30 days
- The investigator feels that for any reason the subject is not eligible to participate in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
New Jersey Clinical Research Center
Montclair, New Jersey, 07042
About this study
Official title: Non-Randomized, Open-label, Blinded Evaluator Study Characterizing Effectiveness of Hybrid Fractional Laser for the Treatment of Off Face Body Skin Quality
To demonstrate effectiveness of hybrid fractional laser for the treatment of poor skin quality on the decolletage, back of the hands and lower legs
- Conditions
- Skin Laxity
- Being tested
- Hybrid Fractional Laser
- Medical subject headings
- Cutis Laxa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hybrid Fractional LaserDevice
Also called HALO
Hybrid Fractional Laser Device
| Study group | Role | What they receive |
|---|---|---|
| Hybrid Fractional Laser | Experimental | Hybrid Fractional Laser Treatment Receives: Device: Hybrid Fractional Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Photography
Evaluate improvement in photography using Physicians Global Assessment Scale (0-4) where 0 is no change and 4 is very significant improvement.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2019
- Study start29 Apr 2019
- Primary completion30 Sep 2020
- Study completion12 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin LaxityStudies 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
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sciton
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03969485
- Sponsor's protocol ID
- HALOCIP002
- Status last verified
- Oct 2020
- First submitted
- 29 May 2019
- Last updated
- 20 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Randomized, Open-label, Blinded Evaluator Study Characterizing Effectiveness of Hybrid Fractional Laser for the Treatment of Off Face Body Skin Quality
- ClinicalTrials.gov ID
- NCT03969485
- Acronym / sponsor ID
- HALOCIP002
- Conditions
- Skin Laxity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- ScitonIndustry (pharma, biotech, devices)
- Study start
- 29 Apr 2019 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 12 Oct 2020 (actual)
- First posted
- 31 May 2019 (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.
To demonstrate effectiveness of hybrid fractional laser for the treatment of poor skin quality on the decolletage, back of the hands and lower legs
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hybrid Fractional Laser | Experimental | Device: Hybrid Fractional LaserHybrid Fractional Laser Treatment |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Healthy male/female subjects between 40 to 65 years of age inclusive
- Fitzpatrick skin type I-III
- Non-smokers or have not smoked (including vaping) within the past 14 days from the screening visit
- Has poor skin texture
- Has mild thin skin
Key exclusion criteria (15 listed)
- Fitzpatrick skin type IV-VI
- Has tanned within the past 30 days or is unable or unlikely to refrain from tanning, including the use of tanning booths, tanning spray or cream
- Has tattoos, dysplastic nevi on the treatment area
- Is pregnant and/or lactating
- History or current photosensitivity
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 |
|---|---|---|
| Hybrid Fractional LaserAlso: HALOHybrid Fractional Laser Device | Device | Hybrid Fractional Laser |
Primary outcome
Photography
Time frame: 3 months
Evaluate improvement in photography using Physicians Global Assessment Scale (0-4) where 0 is no change and 4 is very significant improvement.
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 20 Oct 2020.
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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 Hybrid Fractional Laser in people with Skin Laxity, run by Sciton 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 9 inclusion and 15 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 20 Oct 2020. 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?
Photography (time frame: 3 months). 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 20 Oct 2020.