Laser Removal of Age (Sun) Spots on Hands



Status:Completed
Conditions:Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - 60
Updated:4/21/2016
Start Date:June 2013
End Date:August 2014

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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.

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.

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.
We found this trial at
1
site
Brisbane, California 94005
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Brisbane, CA
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