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

Not Applicable

Completed

• Conditions: Lentigines
• Interventions: Device: Enlighten Laser; Device: Excel V Laser

• Registration Number: NCT02763072
• Lead Sponsor: Cutera Inc.

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.

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 Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-04-25
• Study First Submitted QC: 2016-05-04
• Study First Posted: 2016-05-05
• Primary Completion: 2017-06
• Study Completion: 2017-06-26
• Results First Submitted: 2023-03-14
• Status Verified: 2023-05
• Results First Submitted QC: 2023-05-05
• Last Update Submitted: 2023-05-05
• Results First Posted: 2023-06-02
• Last Update Posted: 2023-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enlighten Laser	Enlighten Laser	12 subjects will receive treatment the Enlighten laser.
Excel V Laser	Excel V Laser	12 subjects will receive treatment with the Excel V laser.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Subject Satisfaction	4 weeks post final treatment	Subject-completed questionnaire to rate their level of satisfaction with the laser treatment outcome
Physician's Global Assessment Score of Skin Texture of the Hands	4 weeks post final treatment	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
Physician's Global Assessment Score of the Overall Appearance of the Hands	4 weeks post final treatment	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

Trial Locations

Locations (1)

DuPage Medical Group; 🇺🇸 Naperville, Illinois, United States