LentiginesNCT02763072
A Single-Center 2-Arm Study for Lentigines on the Hands
A study testing Enlighten Laser and Excel V Laser in people with Lentigines, run by Cutera Inc. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effectiveness and safety of two laser systems for improvement of lentigines on the hands. Read more about this study
- Who is it for?
- Ages 30 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Lentigines
- What is being tested?
- Enlighten Laser and Excel V Laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to 26 Jun 2017
- 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 30 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female or Male, 30-90 years of age (inclusive).
- Fitzpatrick Skin Type I - III.
- Desires non-invasive and non-ablative treatment of lentigines on the hand(s).
- Have 4 or more lentigines on the hand(s).
- 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 50 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 treatment of lentigines 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 to the treatment area during the study.
Who cannot join
- Participation in a clinical trial of another device or drug in the target area 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.
- Systemic use of retinoid, such as isotretinoin, within 6 months of study participation.
- Use of topical medications on the hands, 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.
- Skin abnormalities in the target area, e.g., cuts, scrapes, wounds, scars, large moles.
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- Pregnant.
- Having an infection, dermatitis, or a rash in the treatment area.
- History of keloid scarring, hypertrophic scarring or of abnormal wound healing.
- Any use of medication that is known to increase sensitivity to light according to investigator's discretion.
- 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.
- In the opinion of the investigator, any physical or mental condition which might make it unsafe for the subject to participate in this study or which requires systematic therapy that could interfere with this research study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Center 2-Arm Study of the Enlighten and Excel V Laser for Lentigines on the Hands
The purpose of this study is to evaluate the effectiveness and safety of two laser systems for improvement of lentigines on the hands.
Read the detailed description
The purpose of this study is to evaluate the effectiveness and safety in a clinic setting of two laser systems for the treatment of lentigines (liver spots, age spots, or dark sun spots) on the hands.
- Conditions
- Lentigines
- Being tested
- Enlighten Laser, Excel V Laser
- Medical subject headings
- Lentigo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enlighten LaserDevice
Excel V LaserDevice
| Study group | Role | What they receive |
|---|---|---|
| Enlighten Laser | Experimental | 12 subjects will receive treatment the Enlighten laser. Receives: Device: Enlighten Laser |
| Excel V Laser | Active comparator | 12 subjects will receive treatment with the Excel V laser. Receives: Device: Excel V Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Reduction in the Number of Hand Lentigines as Assessed by Blinded Reviewers.
Measured: 4 weeks post-final treatment
Secondary outcomes (3)
Physician's Global Assessment Score of the Overall Appearance of the Hands
Degree of improvement in the overall appearance of the hands as assessed by blinded reviewers using the Physician's Global Assessment scale: 4=Very Significant Improvement,3=Significant Improvement, 2=Moderate Improvement, 1=Mild Improvement and 0=No Change Higher scores indicate better outcomes
Measured: 4 weeks post final treatment
Physician's Global Assessment Score of Skin Texture of the Hands
Degree of improvement in the Skin Texture of the hands as assessed using the Physician's Global Assessment scale: 4=Very Significant Improvement,3=Significant Improvement, 2=Moderate Improvement, 1=Mild Improvement and 0=No Change. Higher scores indicate better outcomes
Measured: 4 weeks post final treatment
Subject Satisfaction
Subject-completed questionnaire to rate their level of satisfaction with the laser treatment outcome
Measured: 4 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 May 2016 (estimated)
- Study startApr 2016
- Primary completionJun 2017
- Study completion26 Jun 2017
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 LentiginesStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cutera Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kelly Stankiewicz, MD FAAD, Principal investigator, DuPage Medical Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02763072
- Sponsor's protocol ID
- C-16-EV09
- Status last verified
- May 2023
- First submitted
- 25 Apr 2016
- Last updated
- 2 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center 2-Arm Study of the Enlighten and Excel V Laser for Lentigines on the Hands
- ClinicalTrials.gov ID
- NCT02763072
- Acronym / sponsor ID
- C-16-EV09
- Conditions
- Lentigines
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Cutera Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2016 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- 26 Jun 2017 (actual)
- First posted
- 5 May 2016 (estimated)
- Results
- Posted 2 Jun 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 study is to evaluate the effectiveness and safety of two laser systems for improvement of lentigines on the hands.
Detailed description
The purpose of this study is to evaluate the effectiveness and safety in a clinic setting of two laser systems for the treatment of lentigines (liver spots, age spots, or dark sun spots) on the hands.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enlighten Laser | Experimental | Device: Enlighten Laser12 subjects will receive treatment the Enlighten laser. |
| Excel V Laser | Active comparator | Device: Excel V Laser12 subjects will receive treatment with the Excel V laser. |
Who may qualify
- Ages
- 30 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Female or Male, 30-90 years of age (inclusive).
- Fitzpatrick Skin Type I - III.
- Desires non-invasive and non-ablative treatment of lentigines on the hand(s).
- Have 4 or more lentigines on the hand(s).
- Subject must be able to read, understand and sign the Informed Consent Form.
Key exclusion criteria (15 listed)
- Participation in a clinical trial of another device or drug in the target area 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.
- Systemic use of retinoid, such as isotretinoin, within 6 months of study participation.
- Use of topical medications on the hands, 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.
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 |
|---|---|---|
| Enlighten Laser | Device | Enlighten Laser |
| Excel V Laser | Device | Excel V Laser |
Primary outcome
Percent Reduction in the Number of Hand Lentigines as Assessed by Blinded Reviewers.
Time frame: 4 weeks post-final treatment
3 secondary outcomes
Physician's Global Assessment Score of the Overall Appearance of the Hands
Time frame: 4 weeks post final treatment
Physician's Global Assessment Score of Skin Texture of the Hands
Time frame: 4 weeks post final treatment
Subject Satisfaction
Time frame: 4 weeks post final treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 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.
Kelly Stankiewicz, MD FAAD principal investigator
DuPage Medical Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enlighten Laser and Excel V Laser in people with Lentigines, 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 10 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 2 Jun 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 2 Jun 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?
Percent Reduction in the Number of Hand Lentigines as Assessed by Blinded Reviewers. (time frame: 4 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 2 Jun 2023.