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

A Single-Center 2-Arm Study of the Enlighten and Excel V Laser for Lentigines on the Hands

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

Study Overview

• Status: Completed
• Conditions: Lentigines
• Intervention / Treatment: Device: Enlighten Laser; Device: Excel V Laser

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Naperville, Illinois, United States, 60563
      • DuPage Medical Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Female or Male, 30-90 years of age (inclusive).
2. Fitzpatrick Skin Type I - III.
3. Desires non-invasive and non-ablative treatment of lentigines on the hand(s).
4. Have 4 or more lentigines on the hand(s).
5. Subject must be able to read, understand and sign the Informed Consent Form.
6. Must be willing and able to adhere to the treatment and follow-up schedule and post-treatment care instructions.
7. 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.
8. Willing to have digital photographs taken of the treatment area and agree to use of photographs for presentation, educational or marketing purposes.
9. 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.
10. 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:

1. Participation in a clinical trial of another device or drug in the target area within 6 months prior to enrollment or during the study.
2. 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.
3. Systemic use of retinoid, such as isotretinoin, within 6 months of study participation.
4. 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.
5. History of malignant tumors in the target area.
6. Skin abnormalities in the target area, e.g., cuts, scrapes, wounds, scars, large moles.
7. Pregnant.
8. Having an infection, dermatitis, or a rash in the treatment area.
9. History of keloid scarring, hypertrophic scarring or of abnormal wound healing.
10. Any use of medication that is known to increase sensitivity to light according to investigator's discretion.
11. History of radiation to the treatment area or undergoing systemic chemotherapy for the treatment of cancer.
12. History of pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation.
13. Anytime in life, having have used gold therapy (gold salts) for disorders such as rheumatologic disease or lupus.
14. Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning during the study.
15. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Enlighten Laser; 12 subjects will receive treatment the Enlighten laser.	Device: Enlighten Laser
Active Comparator: Excel V Laser; 12 subjects will receive treatment with the Excel V laser.	Device: Excel V Laser

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percent Reduction in the Number of Hand Lentigines as Assessed by Blinded Reviewers.	4 weeks post-final treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physician's Global Assessment Score of the Overall Appearance of the Hands	Degree of improvement in the overall appearance of the hands as assessed by blinded reviewers using the Physician's Global Assessment scale: 4=Very Significant Improvement,3=Significant Improvement, 2=Moderate Improvement, 1=Mild Improvement and 0=No Change Higher scores indicate better outcomes	4 weeks post final treatment
Physician's Global Assessment Score of Skin Texture of the Hands	Degree of improvement in the Skin Texture of the hands as assessed using the Physician's Global Assessment scale: 4=Very Significant Improvement,3=Significant Improvement, 2=Moderate Improvement, 1=Mild Improvement and 0=No Change. Higher scores indicate better outcomes	4 weeks post final treatment
Subject Satisfaction	Subject-completed questionnaire to rate their level of satisfaction with the laser treatment outcome	4 weeks post final treatment

Collaborators and Investigators

• Sponsor: Cutera Inc.
• Investigators: Principal Investigator: Kelly Stankiewicz, MD FAAD, DuPage Medical Group

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): June 26, 2017

Study Registration Dates

• First Submitted: April 25, 2016
• First Submitted That Met QC Criteria: May 4, 2016
• First Posted (Estimated): May 5, 2016

Study Record Updates

• Last Update Posted (Estimated): June 2, 2023
• Last Update Submitted That Met QC Criteria: May 5, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Hyperpigmentation; Pigmentation Disorders; Melanosis; Lentigo
• Other Study ID Numbers: C-16-EV09

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: Yes