Laser Removal of Age (Sun) Spots on Hands

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.

Study Overview

• Status: Completed
• Conditions: Solar Lentigines
• Intervention / Treatment: Device: Picosecond QS Nd:YAG Laser

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Brisbane, California, United States, 94005
      • Cutera Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Picosecond QS Nd:YAG Laser; Laser Treatment with Investigational Device	Device: Picosecond QS Nd:YAG Laser; Up to 2 laser treatments delivered 6 weeks apart; Other Names: Cutera

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Cutera Inc.
• Investigators: Principal Investigator: Lourdes Moldre, NP, Cutera Inc.

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: June 21, 2013
• First Submitted That Met QC Criteria: June 24, 2013
• First Posted (Estimate): June 25, 2013

Study Record Updates

• Last Update Posted (Actual): February 27, 2018
• Last Update Submitted That Met QC Criteria: January 30, 2018
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: Sun; Age; Spot
• Additional Relevant MeSH Terms: Skin Diseases; Hyperpigmentation; Pigmentation Disorders; Melanosis; Lentigo
• Other Study ID Numbers: C-13-LPS03 (Other Identifier: Cutera)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No