Clinical trial NCT01885871: Laser Removal of Age (Sun) Spots on Hands
Official title: Safety and Efficacy of Cutera Picosecond Q-Switched Nd:YAG Laser in the Treatment of Solar Lentigines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Solar Lentigines
Keywords: Sun
Age
Spot
Lead sponsor: Cutera Inc.
Sponsor class: INDUSTRY
First posted: 2013-06-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility 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.

Primary outcomes:
measure: Median VAS Improvement Score as Assessed by Blinded Physician Reviewers
timeFrame: 12 weeks post- final treatment
Secondary outcomes:
measure: Percent of Participants With Improvement Score >/=1
timeFrame: 12 weeks post- final treatment
measure: Percent of Participants Satisfied With Improvement (Clearing) in Solar Lentigines
timeFrame: 12 weeks post- final treatment
measure: Mean Pain Score Associated With Laser Treatments
timeFrame: During treatments
measure: Percent of Subjects With Post-treatment Adverse Event
timeFrame: During study duration 0-6 months.
Other outcomes:
Locations:
city: Brisbane
country: United States
facility: Cutera Research Center
state: California
Study officials:
affiliation: Cutera Inc.
name: Lourdes Moldre, NP
role: PRINCIPAL_INVESTIGATOR
References: