Skin PigmentNCT03421691
A Single-Center Open-Label Study of 1064 nm for Nonablative Skin Rejuvenation
A study testing excel V Laser in people with Skin Pigment and Photoaging, run by Cutera Inc. at 1 site in United States.
Trial summary
The purpose of this investigation is to evaluate the safety and efficacy of the Cutera excel V Laser Genesis procedure utilizing the 1064nm laser for skin rejuvenation. Read more about this study
- Who is it for?
- Ages 35 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Pigment, Photoaging
- What is being tested?
- excel V Laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2016to 7 Feb 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 35 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female or Male, 35 to 55 years of age (inclusive).
- Fitzpatrick Skin Type I - IV.
- Desires non-invasive and non-ablative treatment of skin-aging or photo-rejuvenation of the skin.
- Have signs of moderate skin aging, including presence of mild to moderate rhytides around eyes and upper lip, multiple lentigines, diffuse erythema or telangiectasia, and a score between 4 and 7 (inclusive) on the Fitzpatrick Wrinkle Classification Scale.
- Subject must be able to read, understand and sign the Informed Consent Form.
- Must be willing and able to adhere to the treatment and follow-up schedule and post-treatment care instructions.
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- Willing to have very limited sun exposure and use an approved sunscreen of SPF 30 or higher on the treatment area every day for the duration of the study, including the follow-up period.
- Willing to have digital photographs taken of the treatment area and agree to use of photographs for presentation, educational or marketing purposes.
- Agree to not undergo any other procedure(s) for skin rejuvenation during the study, including but not limited to chemical peel, laser and light based device treatment, and home-use device treatment.
- Agree to not undergo any injection of botulinum toxin, collagen, hyaluronic acid filler or other dermal filler during the study.
- Post-menopausal or surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study, and no plans to become pregnant or to father a child for the duration of the study.
Who cannot join
- Participation in a clinical trial of another device or drug within 6 months prior to enrollment or during the study.
- Any type of prior cosmetic treatment to the target area within 6 months of study participation, such as laser or light-based procedures or surgery.
- Prior injection to the face of botulinum toxin, collagen, hyaluronic acid filler or other dermal filler within 6 months of study participation, as applicable.
- Systemic use of retinoid, such as isotretinoin, or corticosteroid, as applicable, within 6 months of study participation.
- Use of topical medications on the face, such as antibiotics, benzoyl peroxide, retinoids (isotretinoin), corticosteroids, hydroquinone, or products containing dihydroxyacetone or alpha-hydroxy with concentration > 8%, within 1 month of participation.
- History of malignant tumors in the target area.
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- Skin abnormalities in the target area, e.g., cuts, scrapes, wounds, scars, large moles.
- Pregnant and/or breastfeeding.
- Having an infection, dermatitis or a rash in the treatment area.
- Significant concurrent illness, such as diabetes mellitus or cardiovascular disease, e.g., uncontrolled hypertension.
- Suffering from coagulation disorders, or taking prescription anticoagulation medication which might make study participation unsafe according to Investigator's discretion.
- History of keloid scarring, hypertrophic scarring or of abnormal wound healing.
- History of immunosuppression/immune deficiency disorders or currently using immunosuppressive medications.
- History of vitiligo, eczema, or psoriasis.
- History of connective tissue disease, such as systemic lupus erythematosus or scleroderma.
- History of seizure disorders due to light.
- Any use of medication that is known to increase sensitivity to light according to Investigator's discretion.
- History of disease stimulated by heat, such as recurrent herpes simplex and/or herpes zoster (shingles) in the treatment area, unless treatment is conducted following a prophylactic regimen.
- History of radiation to the treatment area or undergoing systemic chemotherapy for the treatment of cancer.
- History of pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation.
- Anytime in life, having have used gold therapy (gold salts) for disorders such as rheumatologic disease or lupus.
- Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning during the study.
- Current smoker or history of smoking within 6 months of study participation.
- As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.
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Trial locations and contacts
1 site in 1 country.
United States1 site
Skin Laser and Surgery Specialists of NY and NJ
New York, New York, 10022
About this study
The purpose of this investigation is to evaluate the safety and efficacy of the Cutera excel V Laser Genesis procedure utilizing the 1064nm laser for skin rejuvenation.
Read the detailed description
This is a single-center prospective, open-label uncontrolled study in 15 male or female subjects, age 35 to 55 years who desire non-ablative laser treatment for facial photo-rejuvenation, specifically improvement of rhytides, lentigines, erythema, telangiectasia and skin texture. Subjects will receive laser treatments and complete a follow up visit 12 weeks post-final treatment.
- Conditions
- Skin Pigment, Photoaging
- Being tested
- excel V Laser
- Medical subject headings
- Pigmentation Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
excel V LaserDevice
excel V Laser Genesis procedure utilizing 1064 nm laser
| Study group | Role | What they receive |
|---|---|---|
| Excel V laser | Other | excel V Laser Genesis procedure utilizing 1064 nm laser Receives: Device: excel V Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of Improvement Rating at 12 Weeks Post-final Treatment
The degree of improvement from Baseline observed in the post-treatment photographs at 12 weeks as assessed by independent blinded Reviewers using the Physician's Global Assessment of Improvement Scale (GAIS) Higher scores indicate better outcomes
- 4=Very Significant Improvement
- 3=Significant Improvement
- 2=Moderate Improvement
- 1=Mild Improvement 0=No Change(
Measured: 12 weeks post-final treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start15 Mar 2016
- Primary completion7 Feb 2018
- Study completion7 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Skin PigmentStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cutera Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03421691
- Sponsor's protocol ID
- C-16-EV10
- Status last verified
- Aug 2023
- First submitted
- 23 Jan 2018
- Last updated
- 6 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center Open-Label Study of 1064 nm for Nonablative Skin Rejuvenation
- ClinicalTrials.gov ID
- NCT03421691
- Acronym / sponsor ID
- C-16-EV10
- Conditions
- Skin Pigment, Photoaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Cutera Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Mar 2016 (actual)
- Primary completion
- 7 Feb 2018 (actual)
- Study completion
- 7 Feb 2018 (actual)
- First posted
- 5 Feb 2018 (actual)
- Results
- Posted 6 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this investigation is to evaluate the safety and efficacy of the Cutera excel V Laser Genesis procedure utilizing the 1064nm laser for skin rejuvenation.
Detailed description
This is a single-center prospective, open-label uncontrolled study in 15 male or female subjects, age 35 to 55 years who desire non-ablative laser treatment for facial photo-rejuvenation, specifically improvement of rhytides, lentigines, erythema, telangiectasia and skin texture. Subjects will receive laser treatments and complete a follow up visit 12 weeks post-final treatment.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Excel V laser | Other | Device: excel V Laserexcel V Laser Genesis procedure utilizing 1064 nm laser |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Female or Male, 35 to 55 years of age (inclusive).
- Fitzpatrick Skin Type I - IV.
- Desires non-invasive and non-ablative treatment of skin-aging or photo-rejuvenation of the skin.
- Have signs of moderate skin aging, including presence of mild to moderate rhytides around eyes and upper lip, multiple lentigines, diffuse erythema or telangiectasia, and a score between 4 and 7 (inclusive) on the Fitzpatrick Wrinkle Classification Scale.
- Subject must be able to read, understand and sign the Informed Consent Form.
Key exclusion criteria (25 listed)
- Participation in a clinical trial of another device or drug within 6 months prior to enrollment or during the study.
- Any type of prior cosmetic treatment to the target area within 6 months of study participation, such as laser or light-based procedures or surgery.
- Prior injection to the face of botulinum toxin, collagen, hyaluronic acid filler or other dermal filler within 6 months of study participation, as applicable.
- Systemic use of retinoid, such as isotretinoin, or corticosteroid, as applicable, within 6 months of study participation.
- Use of topical medications on the face, such as antibiotics, benzoyl peroxide, retinoids (isotretinoin), corticosteroids, hydroquinone, or products containing dihydroxyacetone or alpha-hydroxy with concentration > 8%, within 1 month of participation.
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 |
|---|---|---|
| excel V Laserexcel V Laser Genesis procedure utilizing 1064 nm laser | Device | Excel V laser |
Primary outcome
Degree of Improvement Rating at 12 Weeks Post-final Treatment
Time frame: 12 weeks post-final treatment
The degree of improvement from Baseline observed in the post-treatment photographs at 12 weeks as assessed by independent blinded Reviewers using the Physician's Global Assessment of Improvement Scale (GAIS) Higher scores indicate better outcomes * 4=Very Significant Improvement * 3=Significant Improvement * 2=Moderate Improvement * 1=Mild Improvement 0=No Change(
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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 excel V Laser in people with Skin Pigment and Photoaging, run by Cutera Inc. 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 25 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 6 Sep 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?
Yes. Results are posted in the registry (first posted 6 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Degree of Improvement Rating at 12 Weeks Post-final Treatment (time frame: 12 weeks post-final treatment). 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 6 Sep 2023.