Solar LentiginesNCT01885871
Laser Removal of Age (Sun) Spots on Hands
A study testing Picosecond QS Nd:YAG Laser in people with Solar Lentigines, run by Cutera Inc. at 1 site in United States.
Trial summary
The purpose of this study is to determine whether picosecond laser is effective in the treatment of age (sun) spots. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Solar Lentigines
- What is being tested?
- Picosecond QS Nd:YAG Laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Aug 2014
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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 corticosteroids) 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.
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- Must be able to read, understand and sign the Informed Consent 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.
- Post-menopausal or surgically sterilized, or using a medically acceptable form of birth control at last 3 months prior to enrollment and during the entire course of the study.
Who cannot join
- 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.
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- 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 immunosuppression/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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy of Cutera Picosecond Q-Switched Nd:YAG Laser in the Treatment of Solar Lentigines
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
- Solar Lentigines
- Being tested
- Picosecond QS Nd:YAG Laser
- Keywords
- Sun, Age, Spot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Picosecond QS Nd:YAG LaserDevice
Also called Cutera
Up to 2 laser treatments delivered 6 weeks apart
| Study group | Role | What they receive |
|---|---|---|
| Picosecond QS Nd:YAG Laser | Experimental | Laser Treatment with Investigational Device Receives: Device: Picosecond QS Nd:YAG Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks post- final treatment
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: During treatments
Percent of Subjects With Post-treatment Adverse Event
Measured: During study duration 0-6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionJun 2014
- Study completionAug 2014
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 Solar 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cutera Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lourdes Moldre, NP, Principal investigator, Cutera Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01885871
- Sponsor's protocol ID
- C-13-LPS03
- Other IDs
- C-13-LPS03
- Status last verified
- Oct 2015
- First submitted
- 21 Jun 2013
- Last updated
- 27 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Cutera Picosecond Q-Switched Nd:YAG Laser in the Treatment of Solar Lentigines
- ClinicalTrials.gov ID
- NCT01885871
- Acronym / sponsor ID
- C-13-LPS03
- Conditions
- Solar Lentigines
- Keywords
- Sun, Age, Spot
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Cutera Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 25 Jun 2013 (estimated)
- Results
- Posted 12 Oct 2015
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 determine whether picosecond laser is effective in the treatment of age (sun) spots.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Picosecond QS Nd:YAG Laser | Experimental | Device: Picosecond QS Nd:YAG LaserLaser Treatment with Investigational Device |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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 corticosteroids) used in the treatment of pigmentation in the treatment area within the last 4 weeks.
Key exclusion criteria (21 listed)
- 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.
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 |
|---|---|---|
| Picosecond QS Nd:YAG LaserAlso: CuteraUp to 2 laser treatments delivered 6 weeks apart | Device | Picosecond QS Nd:YAG Laser |
Primary outcome
Median VAS Improvement Score as Assessed by Blinded Physician Reviewers
Time frame: 12 weeks post- final treatment
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.
4 secondary outcomes
Percent of Participants With Improvement Score >/=1
Time frame: 12 weeks post- final treatment
Percent of Participants Satisfied With Improvement (Clearing) in Solar Lentigines
Time frame: 12 weeks post- final treatment
Mean Pain Score Associated With Laser Treatments
Time frame: During treatments
Percent of Subjects With Post-treatment Adverse Event
Time frame: During study duration 0-6 months.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes
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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.
Lourdes Moldre, NP principal investigator
Cutera Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Picosecond QS Nd:YAG Laser in people with Solar 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 12 inclusion and 21 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 27 Feb 2018. 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 12 Oct 2015). 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?
Median VAS Improvement Score as Assessed by Blinded Physician Reviewers (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 27 Feb 2018.