Laser Removal of Age (Sun) Spots on Hands

• ClinicalTrials.gov Identifier: NCT01885871
• Recruitment Status: Completed
• First Posted: June 25, 2013
• Results First Posted: October 12, 2015
• Last Update Posted: February 27, 2018
• Sponsor: Cutera Inc.
• Information provided by (Responsible Party): Cutera Inc.

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Solar Lentigines	Device: Picosecond QS Nd:YAG Laser	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Safety and Efficacy of Cutera Picosecond Q-Switched Nd:YAG Laser in the Treatment of Solar Lentigines
• Study Start Date: June 2013
• Actual Primary Completion Date: June 2014
• Actual Study Completion Date: August 2014

Arms and Interventions

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 Name: Cutera

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. Percent of Participants With Improvement Score >/=1 [ Time Frame: 12 weeks post- final treatment ]
   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.
2. Percent of Participants Satisfied With Improvement (Clearing) in Solar Lentigines [ Time Frame: 12 weeks post- final treatment ]
   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.
3. Mean Pain Score Associated With Laser Treatments [ Time Frame: During 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.
4. Percent of Subjects With Post-treatment Adverse Event [ Time Frame: During study duration 0-6 months. ]

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Locations

United States, California

Cutera Research Center

Brisbane, California, United States, 94005

Sponsors and Collaborators

Cutera Inc.

Investigators

• Principal Investigator: Lourdes Moldre, NP; Cutera Inc.

More Information

• Responsible Party: Cutera Inc.
• ClinicalTrials.gov Identifier: NCT01885871
• Other Study ID Numbers: C-13-LPS03; C-13-LPS03 ( Other Identifier: Cutera )
• First Posted: June 25, 2013
• Results First Posted: October 12, 2015
• Last Update Posted: February 27, 2018
• Last Verified: October 2015

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes

Keywords provided by Cutera Inc.:

Sun; Age; Spot

Additional relevant MeSH terms:

Lentigo; Melanosis; Hyperpigmentation; Pigmentation Disorders; Skin Diseases