Laser Removal of Age (Sun) Spots on Hands

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

Detailed Description
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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.

Official Title
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Safety and Efficacy of Cutera Picosecond Q-Switched Nd:YAG Laser in the Treatment of Solar Lentigines

Conditions
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Solar Lentigines

Intervention / Treatment
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* Device: Picosecond QS Nd:YAG Laser


Participation Criteria
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Eligibility Criteria
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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 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. 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. 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 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Picosecond QS Nd:YAG Laser<br>Laser Treatment with Investigational Device | Device: Picosecond QS Nd:YAG Laser<br>* Up to 2 laser treatments delivered 6 weeks apart<br>* Other names: Cutera;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 weeks post- final treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | During treatments | 
| Percent of Subjects With Post-treatment Adverse Event |  | During study duration 0-6 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sun, Age, Spot