Lentigines
Conditions
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.
Interventions
DEVICEEnlighten Laser
DEVICEExcel V Laser
Sponsors
Cutera Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 90 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent Reduction in the Number of Hand Lentigines as Assessed by Blinded Reviewers. | 4 weeks post-final treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| Subject Satisfaction | 4 weeks post final treatment | Subject-completed questionnaire to rate their level of satisfaction with the laser treatment outcome |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Excel V Laser 12 subjects will be enrolled in the Excel V group | 12 |
| Enlighten Laser 12 subjects will be enrolled in the Enlighten group | 12 |
| Total | 24 |
Baseline characteristics
| Characteristic | Excel V Laser | Enlighten Laser | Total |
|---|---|---|---|
| Age, Continuous | 61.8 years STANDARD_DEVIATION 9 | 64.8 years STANDARD_DEVIATION 8.6 | 63.3 years STANDARD_DEVIATION 8.7 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 12 participants | 12 participants | 24 participants |
| Sex: Female, Male Female | 12 Participants | 12 Participants | 24 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 12 |
| other Total, other adverse events | 6 / 12 | 9 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 |
Outcome results
Primary
Percent Reduction in the Number of Hand Lentigines as Assessed by Blinded Reviewers.
Time frame: 4 weeks post-final treatment
Population: Study terminated prior to outcome data collected due to company change in priorities.
Secondary
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
Time frame: 4 weeks post final treatment
Population: 1 subject was lost to follow up in the Excel V group
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Enlighten Laser | Physician's Global Assessment Score of Skin Texture of the Hands | 2.9 score on a scale | Standard Deviation 1.8 |
| Excel V Laser | Physician's Global Assessment Score of Skin Texture of the Hands | 3.1 score on a scale | Standard Deviation 1.1 |
Secondary
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
Time frame: 4 weeks post final treatment
Population: 1 subject was lost to follow up in the Excel V group
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Enlighten Laser | Physician's Global Assessment Score of the Overall Appearance of the Hands | 3.8 score on a scale | Standard Deviation 0.6 |
| Excel V Laser | Physician's Global Assessment Score of the Overall Appearance of the Hands | 3.9 score on a scale | Standard Deviation 0.3 |
Secondary
Subject Satisfaction
Subject-completed questionnaire to rate their level of satisfaction with the laser treatment outcome
Time frame: 4 weeks post final treatment
Population: 1 subject was lost to follow up in the Excel V group
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Enlighten Laser | Subject Satisfaction | Very Satisfied | 9 Participants |
| Enlighten Laser | Subject Satisfaction | Satisfied | 2 Participants |
| Enlighten Laser | Subject Satisfaction | Neutral | 1 Participants |
| Excel V Laser | Subject Satisfaction | Satisfied | 3 Participants |
| Excel V Laser | Subject Satisfaction | Neutral | 0 Participants |
| Excel V Laser | Subject Satisfaction | Very Satisfied | 8 Participants |