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

NCT02763072 | Completed Results FDA Device

• 1 other identifier: C-16-EV09
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Lentigines

Outcome Measures

Primary Outcomes (1)

• Percent Reduction in the Number of Hand Lentigines as Assessed by Blinded Reviewers.

  4 weeks post-final treatment

Secondary Outcomes (3)

• Physician's Global Assessment Score of the Overall Appearance of the Hands

  4 weeks post final treatment

• Physician's Global Assessment Score of Skin Texture of the Hands

  4 weeks post final treatment

• Subject Satisfaction

  4 weeks post final treatment

Study Arms (2)

Enlighten Laser

EXPERIMENTAL

12 subjects will receive treatment the Enlighten laser.

Device: Enlighten Laser

Excel V Laser

ACTIVE COMPARATOR

12 subjects will receive treatment with the Excel V laser.

Device: Excel V Laser

Interventions

Enlighten Laser DEVICE

Enlighten Laser

Excel V Laser DEVICE

Excel V Laser

Eligibility Criteria

• Age: 30 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cutera Inc.: lead

Study Sites (1)

DuPage Medical Group

Naperville, Illinois, 60563, United States

Location

MeSH Terms

Conditions

Lentigo

Condition Hierarchy (Ancestors)

Melanosis; Hyperpigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Margot Doucette
• Organization: Cutera

mdoucette@cutera.com

415-656-9612

Study Officials

• Kelly Stankiewicz, MD FAAD

  DuPage Medical Group

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2016
• First Posted: May 5, 2016
• Study Start: April 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 26, 2017
• Last Updated: June 2, 2023
• Results First Posted: June 2, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)