CompletedNCT02763072Updated Jun 2, 2023Results posted

A Single-Center 2-Arm Study for Lentigines on the Hands

An interventional study of Enlighten Laser and Excel V Laser in Lentigines, sponsored by Cutera Inc.. Completed at 1 site in United States. Open to participants aged 30 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-02.

Sponsored by Cutera Inc. · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 24
Allocation: Randomized
Ages: 30 Years to 90 Years
Sex: All

Study 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 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 studied

Lentigines

Browse trials for

Lentigo 28

In context

Lentigo

28 studies on the registry are indexed under Lentigo; 2 are open to participants now.

This study's enrollment of 24 is below the median of 30 across 25 interventional studies indexed under Lentigo.

Browse Lentigo studies →

Lead sponsor

Cutera Inc. is the lead sponsor of 42 studies on the registry; none are open to participants now.

Of its 19 completed or terminated interventional studies of FDA-regulated products, 19 (100%) have results posted.

Browse Cutera Inc. studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 30 Years to 90 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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 Form.
Must be willing and able to adhere to the treatment and follow-up schedule and post-treatment care instructions.
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.

Exclusion criteria

Exclusion Criteria:

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), , 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.
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.

Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 24 participants (actual)

Study arms

Experimental
Enlighten Laser
12 subjects will receive treatment the Enlighten laser.
Device: Enlighten Laser
Active comparator
Excel V Laser
12 subjects will receive treatment with the Excel V laser.
Device: Excel V Laser

Interventions

DeviceEnlighten Laser
DeviceExcel V Laser

What researchers measure

Primary outcomes

Percent Reduction in the Number of Hand Lentigines as Assessed by Blinded Reviewers.
Time frame: 4 weeks post-final treatment

Secondary outcomes

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
Time frame: 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
Time frame: 4 weeks post final treatment
Subject Satisfaction
Subject-completed questionnaire to rate their level of satisfaction with the laser treatment outcome
Time frame: 4 weeks post final treatment

Results

Posted Jun 2, 2023

Participant flow

Participant flow — Overall Study
Milestone	Excel V Laser	Enlighten Laser
Started	12	12
Completed	11	12
Not completed	1	0

Outcome measures

PrimaryPercent Reduction in the Number of Hand Lentigines as Assessed by Blinded Reviewers.

Time frame:: 4 weeks post-final treatment

No measurements were reported for this outcome.

SecondaryPhysician'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

Time frame:: 4 weeks post final treatment
Reported as:: Mean · score on a scale

Physician's Global Assessment Score of the Overall Appearance of the Hands
score on a scale	Enlighten Laser	Excel V Laser
Physician's Global Assessment Score of the Overall Appearance of the Hands	3.8 ± 0.6	3.9 ± 0.3

SecondaryPhysician'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

Time frame:: 4 weeks post final treatment
Reported as:: Mean · score on a scale

Physician's Global Assessment Score of Skin Texture of the Hands
score on a scale	Enlighten Laser	Excel V Laser
Physician's Global Assessment Score of Skin Texture of the Hands	2.9 ± 1.8	3.1 ± 1.1

SecondarySubject Satisfaction

Subject-completed questionnaire to rate their level of satisfaction with the laser treatment outcome

Time frame:: 4 weeks post final treatment
Reported as:: Count of participants · Participants

Subject Satisfaction
Participants	Enlighten Laser	Excel V Laser
Very Satisfied	9	8
Satisfied	2	3
Neutral	1	0

Adverse events

Collected over 4 weeks post final treatment, up to 17 weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Excel V Laser	0/12 (0%)	0/12 (0%)	6/12 (50%)
Enlighten Laser	0/12 (0%)	0/12 (0%)	9/12 (75%)

Most frequent other events

Most frequent other events
Event	Excel V Laser	Enlighten Laser
ErythemaSkin and subcutaneous tissue disorders	6/12	9/12
Darkening of vesselSkin and subcutaneous tissue disorders	0/12	5/12
HyperpigmentationSkin and subcutaneous tissue disorders	3/12	3/12

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Excel V Laser	Enlighten Laser	Total
Mean	61.8 ± 9.0	64.8 ± 8.6	63.3 ± 8.7

Sex: Female, Male
Sex: Female, Male(Participants)	Excel V Laser	Enlighten Laser	Total
Female	12	12	24
Male	0	0	0

Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)	Excel V Laser	Enlighten Laser	Total
Count of participants	—	—	0

Region of Enrollment
Region of Enrollment(participants)	Excel V Laser	Enlighten Laser	Total
United States	12	12	24

Study locations

1 site

DuPage Medical Group
Naperville, Illinois 60563, United States

References and documents

Study documents

Protocol and statistical analysis plan ↗ · Apr 6, 2016

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 2, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02763072
Lead sponsor: Cutera Inc.
Responsible party: Sponsor
First posted: May 5, 2016
Start date: Apr 2016
Primary completion: Jun 2017
Completion: Jun 26, 2017
Results posted: Jun 2, 2023
Last update: Jun 2, 2023

Study contacts

Kelly Stankiewicz, MD FAAD

principal investigator · DuPage Medical Group

Oversight

FDA-regulated device: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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