CompletedNCT01885871Updated Feb 27, 2018Results posted

Laser Removal of Age (Sun) Spots on Hands

An interventional study of Picosecond QS Nd:YAG Laser in Solar Lentigines, sponsored by Cutera Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2018-02-27.

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

Phase: Not applicable
Study type: Interventional
Enrollment: 20
Allocation: Not applicable
Ages: 18 Years to 60 Years
Sex: All

Study summary

The purpose of this study is to determine whether picosecond laser is effective in the treatment of age (sun) spots.

Read the detailed description

The purpose of this study is to evaluate the safety and efficacy of Cutera Picosecond Q-Switched Nd:YAG 1064 and/or 532 nm laser in the treatment of benign pigmented lesions on the hands.

Conditions studied

Solar Lentigines

Browse trials for

Lentigo 28

Keywords

Sun
Age
Spot

In context

Lentigo

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

This study's enrollment of 20 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: 18 Years to 60 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

Females or Males, 18 to 60 years of age (inclusive).
Fitzpatrick Skin Type I - III (Appendix 2).
Clinical diagnosis of benign solar lentigines of the hands.
Presence of at least 5 lesions in the treatment area in diameters ranging from 1 to 8 mm.
Has not used any prescription or over the counter topical creams (e.g., hydroquinone, and/or retinoids and/or ) used in the treatment of pigmentation in the treatment area within the last 4 weeks.
Willing to refrain from using any prescription or over the counter topical creams used for the treatment of pigmentation (e.g., hydroquinone, and/or retinoids and/or corticosteroids) in the treatment area during the study period.
Must be able to read, understand and sign the Form.
Willing and able to adhere to the treatment and follow-up schedule and before and after treatment care instructions.
Willing to protect and/or have very limited sun exposure and use an approved sunscreen of SPF 50 or higher in the treatment area starting up to 4 weeks before the treatment, every day for the duration of the study, including the follow-up period
Willing to have digital photographs taken of the treatment area
Agree not to undergo any other procedure(s) for the treatment of solar lentigines during the study.
or surgically sterilized, or using a medically acceptable form of at last 3 months prior to enrollment and during the entire course of the study.

Exclusion criteria

Exclusion Criteria:

Participation in a study of another device of drug within 6 months prior to enrollment or during the study.
Prior treatment of solar lentigines of the hands, e.g., with Q-Switched laser, IPL, Chemical peel, cryotherapy within 6 months of study participation.
Having pre-malignant or malignant lesions (e.g., pigmented actinic keratosis, lentigo maligna [12], lentigo maligna melanoma), or history of a pre-malignant or malignant lesion in the treatment area.
Subject shows signs of actinic bronzing or recent tanning in the treatment area, and unable/unlikely to refrain from tanning during the study.
Skin abnormalities in the treatment 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 medications.
History of keloid scarring, hypertrophic scarring or of abnormal wound healing.
History of /immune deficiency disorders or currently using immunosuppression medications.
History of vitiligo 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, such as tetracycline.
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.
Current smoker or history of smoking within 2 years 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.
History of allergy to topical antibiotics.

Terms in these criteria, in plain language(5)

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.

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.

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.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 20 participants (actual)

Study arms

Experimental
Picosecond QS Nd:YAG Laser
Laser Treatment with Investigational Device
Device: Picosecond QS Nd:YAG Laser

Interventions

DevicePicosecond QS Nd:YAG Laser
Up to 2 laser treatments delivered 6 weeks apart
Also known as: Cutera

What researchers measure

Primary outcomes

Median VAS Improvement Score as Assessed by Blinded Physician Reviewers
Improvement (clearing) in solar lentigines as assessed by blinded physician reviewers using a VAS 4 point scale 0-3 where 0=no change and 3=Very much improved.
Time frame: 12 weeks post- final treatment

Secondary outcomes

Percent of Participants With Improvement Score >/=1
Improvement (clearing) in solar lentigines as assessed by participant using a 4-point VAS 0-3 scale where 0=no change and 3=very much improved. Scores \>/=1 indicate improvement.
Time frame: 12 weeks post- final treatment
Percent of Participants Satisfied With Improvement (Clearing) in Solar Lentigines
Level of Satisfaction with Improvement (clearing) in solar lentigines as assessed by participants, as measured by spot Improvement: 3=Very Much Improved, 2=Much Improved, 1=Improved, and 0=No Change.
Time frame: 12 weeks post- final treatment
Mean Pain Score Associated With Laser Treatments
Subjects graded the level of pain associated with each laser treatment, using a 0-10 scale where 0=no pain and 10=worse possible pain, then averaged to get the mean across the treatments.
Time frame: During treatments
Percent of Subjects With Post-treatment Adverse Event
Time frame: During study duration 0-6 months.

Results

Posted Oct 12, 2015

Participant flow

Participant flow — Overall Study
Milestone	Picosecond Q-Switched Nd:YAG 1064/532 nm Laser
Started	20
Completed	20
Not completed	0

Outcome measures

PrimaryMedian VAS Improvement Score as Assessed by Blinded Physician Reviewers

Improvement (clearing) in solar lentigines as assessed by blinded physician reviewers using a VAS 4 point scale 0-3 where 0=no change and 3=Very much improved.

Time frame:: 12 weeks post- final treatment
Reported as:: Median · units on a scale

Median VAS Improvement Score as Assessed by Blinded Physician Reviewers
units on a scale	Picosecond Q-Switched Nd:YAG 1064/532 nm Laser
Median VAS Improvement Score as Assessed by Blinded Physician Reviewers	1.5 (1.25 to 2)

Statistical analysis

Picosecond Q-Switched Nd:YAG 1064/532 nm Laser · Wilcoxon (Mann-Whitney) · p = <0.0001

SecondaryPercent of Participants With Improvement Score >/=1

Improvement (clearing) in solar lentigines as assessed by participant using a 4-point VAS 0-3 scale where 0=no change and 3=very much improved. Scores \>/=1 indicate improvement.

Time frame:: 12 weeks post- final treatment
Reported as:: Number · percent of participants

Percent of Participants With Improvement Score >/=1
percent of participants	Picosecond Q-Switched Nd:YAG 1064/532 nm Laser
Percent of Participants With Improvement Score >/=1	90

SecondaryPercent of Participants Satisfied With Improvement (Clearing) in Solar Lentigines

Level of Satisfaction with Improvement (clearing) in solar lentigines as assessed by participants, as measured by spot Improvement: 3=Very Much Improved, 2=Much Improved, 1=Improved, and 0=No Change.

Time frame:: 12 weeks post- final treatment
Reported as:: Number · percent of participants

Percent of Participants Satisfied With Improvement (Clearing) in Solar Lentigines
percent of participants	Picosecond Q-Switched Nd:YAG 1064/532 nm Laser
Percent of Participants Satisfied With Improvement (Clearing) in Solar Lentigines	95

SecondaryMean Pain Score Associated With Laser Treatments

Subjects graded the level of pain associated with each laser treatment, using a 0-10 scale where 0=no pain and 10=worse possible pain, then averaged to get the mean across the treatments.

Time frame:: During treatments
Reported as:: Mean · units on a scale

Mean Pain Score Associated With Laser Treatments
units on a scale	Picosecond Q-Switched Nd:YAG 1064/532 nm Laser
Mean Pain Score Associated With Laser Treatments	2.0 (1.0 to 5.0)

SecondaryPercent of Subjects With Post-treatment Adverse Event

Time frame:: During study duration 0-6 months.
Reported as:: Number · percent of participants

Percent of Subjects With Post-treatment Adverse Event
percent of participants	Picosecond Q-Switched Nd:YAG 1064/532 nm Laser
Erythema (redness)	100
Edema (swelling)	100
Crusting (scabbing)	100
Purpura (bruising)	65
Blisters	15
Eczema	5

Adverse events

Collected over Adverse Event Data was collected immediately post treatment, 3 days and 14 days after treatment as well as 6, 12, and 24 weeks.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Picosecond Q-Switched Nd:YAG 1064/532 nm Laser	—	0/20 (0%)	20/20 (100%)

Most frequent other events

Most frequent other events
Event	Picosecond Q-Switched Nd:YAG 1064/532 nm Laser
Edema (swelling)Skin and subcutaneous tissue disorders	20/20
Erythema (Redness)Skin and subcutaneous tissue disorders	20/20
Purpura (Bruising)Skin and subcutaneous tissue disorders	13/20
BlistersSkin and subcutaneous tissue disorders	3/20
EczemaSkin and subcutaneous tissue disorders	1/20

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Picosecond Q-Switched Nd:YAG 1064/532 nm Laser
Mean	52 (41 to 67)

Age, Categorical
Age, Categorical(Participants)	Picosecond Q-Switched Nd:YAG 1064/532 nm Laser
<=18 years	0
Between 18 and 65 years	19
>=65 years	1

Sex: Female, Male
Sex: Female, Male(Participants)	Picosecond Q-Switched Nd:YAG 1064/532 nm Laser
Female	13
Male	7

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Picosecond Q-Switched Nd:YAG 1064/532 nm Laser
American Indian or Alaska Native	0
Asian	0
Native Hawaiian or Other Pacific Islander	0
Black or African American	0
White	20
More than one race	0
Unknown or Not Reported	0

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Picosecond Q-Switched Nd:YAG 1064/532 nm Laser
Hispanic or Latino	2
Not Hispanic or Latino	18
Unknown or Not Reported	0

Region of Enrollment
Region of Enrollment(participants)	Picosecond Q-Switched Nd:YAG 1064/532 nm Laser
United States	20

Study locations

1 site

Cutera Research Center
Brisbane, California 94005, United States

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

Timeline

Tracking since Sep 25, 2026

Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jun 2013, a primary completion of Jun 2014 and a completion of Aug 2014. It does not say whether these dates are actual or estimated.

Results were first posted in Oct 2015, 1 year 4 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered: Jun 21, 2013
First posted: Jun 25, 2013
Start: Jun 2013
Primary completionActual: Jun 2014
CompletionActual: Aug 2014
Results first posted: Oct 12, 2015
Last update: Feb 27, 2018

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Feb 27, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01885871
Lead sponsor: Cutera Inc.
Responsible party: Sponsor
First posted: Jun 25, 2013
Start date: Jun 2013
Primary completion: Jun 2014
Completion: Aug 2014
Results posted: Oct 12, 2015
Last update: Feb 27, 2018

Study contacts

Lourdes Moldre, NP

principal investigator · Cutera Inc.

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.

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