A Single-Center 2-Arm Study for Lentigines on the Hands

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Cutera

Status

Completed

Conditions

Lentigines

Treatments

Device: Enlighten Laser
Device: Excel V Laser

Study type

Interventional

Funder types

Industry

Identifiers

NCT02763072
C-16-EV09

Details and patient eligibility

About

The purpose of this study is to evaluate the effectiveness and safety of two laser systems for improvement of lentigines on the hands.

Full description

The purpose of this study is to evaluate the effectiveness and safety in a clinic setting of two laser systems for the treatment of lentigines (liver spots, age spots, or dark sun spots) on the hands.

Enrollment

24 patients

Sex

All

Ages

30 to 90 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Female or Male, 30-90 years of age (inclusive).
  • Fitzpatrick Skin Type I - III.
  • Desires non-invasive and non-ablative treatment of lentigines on the hand(s).
  • Have 4 or more lentigines on the hand(s).
  • Subject must be able to read, understand and sign the Informed Consent Form.
  • Must be willing and able to adhere to the treatment and follow-up schedule and post-treatment care instructions.
  • Willing to have very limited sun exposure and use an approved sunscreen of SPF 50 or higher on the treatment area every day for the duration of the study, including the follow-up period.
  • Willing to have digital photographs taken of the treatment area and agree to use of photographs for presentation, educational or marketing purposes.
  • Agree to not undergo any other procedure(s) for treatment of lentigines during the study, including but not limited to chemical peel, laser and light based device treatment, and home-use device treatment.
  • Agree to not undergo any injection of botulinum toxin, collagen, hyaluronic acid filler or other dermal filler to the treatment area during the study.

Exclusion criteria

  • Participation in a clinical trial of another device or drug in the target area within 6 months prior to enrollment or during the study.
  • Any type of prior cosmetic treatment to the target area within 6 months of study participation, such as laser or light-based procedures or surgery.
  • Systemic use of retinoid, such as isotretinoin, within 6 months of study participation.
  • Use of topical medications on the hands, such as antibiotics, benzoyl peroxide, retinoids (isotretinoin), corticosteroids, hydroquinone, or products containing dihydroxyacetone or alpha-hydroxy with concentration > 8%, within 1 month of participation.
  • History of malignant tumors in the target area.
  • Skin abnormalities in the target area, e.g., cuts, scrapes, wounds, scars, large moles.
  • Pregnant.
  • Having an infection, dermatitis, or a rash in the treatment area.
  • History of keloid scarring, hypertrophic scarring or of abnormal wound healing.
  • Any use of medication that is known to increase sensitivity to light according to investigator's discretion.
  • 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.
  • Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning during the study.
  • In the opinion of the investigator, any physical or mental condition which might make it unsafe for the subject to participate in this study or which requires systematic therapy that could interfere with this research study.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

24 participants in 2 patient groups

Enlighten Laser
Experimental group
Description:
12 subjects will receive treatment the Enlighten laser.
Treatment:
Device: Enlighten Laser
Excel V Laser
Active Comparator group
Description:
12 subjects will receive treatment with the Excel V laser.
Treatment:
Device: Excel V Laser

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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