Solar Lentigines
Conditions
Keywords
Sun, Age, Spot
Brief summary
The purpose of this study is to determine whether picosecond laser is effective in the treatment of age (sun) spots.
Detailed description
The purpose of this study is to evaluate the safety and efficacy of Cutera Picosecond Q-Switched Nd:YAG 1064 and/or 532 nm laser in the treatment of benign pigmented lesions on the hands.
Interventions
DEVICEPicosecond QS Nd:YAG Laser
Up to 2 laser treatments delivered 6 weeks apart
Sponsors
Cutera Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Females or Males, 18 to 60 years of age (inclusive). * Fitzpatrick Skin Type I - III (Appendix 2). * Clinical diagnosis of benign solar lentigines of the hands. * Presence of at least 5 lesions in the treatment area in diameters ranging from 1 to 8 mm. * Has not used any prescription or over the counter topical creams (e.g., hydroquinone, and/or retinoids and/or corticosteroids) used in the treatment of pigmentation in the treatment area within the last 4 weeks. * Willing to refrain from using any prescription or over the counter topical creams used for the treatment of pigmentation (e.g., hydroquinone, and/or retinoids and/or corticosteroids) in the treatment area during the study period. * Must be able to read, understand and sign the Informed Consent Form. * Willing and able to adhere to the treatment and follow-up schedule and before and after treatment care instructions. * Willing to protect and/or have very limited sun exposure and use an approved sunscreen of SPF 50 or higher in the treatment area starting up to 4 weeks before the treatment, every day for the duration of the study, including the follow-up period * Willing to have digital photographs taken of the treatment area * Agree not to undergo any other procedure(s) for the treatment of solar lentigines during the study. * Post-menopausal or surgically sterilized, or using a medically acceptable form of birth control at last 3 months prior to enrollment and during the entire course of the study.
Exclusion criteria
* Participation in a study of another device of drug within 6 months prior to enrollment or during the study. * Prior treatment of solar lentigines of the hands, e.g., with Q-Switched laser, IPL, Chemical peel, cryotherapy within 6 months of study participation. * Having pre-malignant or malignant lesions (e.g., pigmented actinic keratosis, lentigo maligna \[12\], lentigo maligna melanoma), or history of a pre-malignant or malignant lesion in the treatment area. * Subject shows signs of actinic bronzing or recent tanning in the treatment area, and unable/unlikely to refrain from tanning during the study. * Skin abnormalities in the treatment area, e.g., cuts, scrapes, wounds, scars, large moles. * Pregnant and/or breastfeeding. * Having an infection, dermatitis or a rash in the treatment area. * Significant concurrent illness, such as diabetes mellitus or cardiovascular disease, e.g., uncontrolled hypertension * Suffering from coagulation disorders or taking prescription anticoagulation medications. * History of keloid scarring, hypertrophic scarring or of abnormal wound healing. * History of immunosuppression/immune deficiency disorders or currently using immunosuppression medications. * History of vitiligo or psoriasis. * History of connective tissue disease, such as systemic lupus erythematosus or scleroderma. * History of seizure disorders due to light. * Any use of medication that is known to increase sensitivity to light, such as tetracycline. * 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. * Current smoker or history of smoking within 2 years of study participation. * As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study. * History of allergy to topical antibiotics.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Median VAS Improvement Score as Assessed by Blinded Physician Reviewers | 12 weeks post- final treatment | Improvement (clearing) in solar lentigines as assessed by blinded physician reviewers using a VAS 4 point scale 0-3 where 0=no change and 3=Very much improved. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Participants With Improvement Score >/=1 | 12 weeks post- final treatment | Improvement (clearing) in solar lentigines as assessed by participant using a 4-point VAS 0-3 scale where 0=no change and 3=very much improved. Scores \>/=1 indicate improvement. |
| Percent of Participants Satisfied With Improvement (Clearing) in Solar Lentigines | 12 weeks post- final treatment | Level of Satisfaction with Improvement (clearing) in solar lentigines as assessed by participants, as measured by spot Improvement: 3=Very Much Improved, 2=Much Improved, 1=Improved, and 0=No Change. |
| Mean Pain Score Associated With Laser Treatments | During treatments | Subjects graded the level of pain associated with each laser treatment, using a 0-10 scale where 0=no pain and 10=worse possible pain, then averaged to get the mean across the treatments. |
| Percent of Subjects With Post-treatment Adverse Event | During study duration 0-6 months. | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Picosecond Q-Switched Nd:YAG 1064/532 nm Laser Picosecond Q-Switched Nd:YAG 1064/532 nm Laser: Up to 2 laser treatments delivered 6 weeks apart | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Picosecond Q-Switched Nd:YAG 1064/532 nm Laser |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 19 Participants |
| Age, Continuous | 52 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 18 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 20 Participants |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 20 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Median VAS Improvement Score as Assessed by Blinded Physician Reviewers
Improvement (clearing) in solar lentigines as assessed by blinded physician reviewers using a VAS 4 point scale 0-3 where 0=no change and 3=Very much improved.
Time frame: 12 weeks post- final treatment
Population: Based on blinded photographic assessments of 20 subjects. Scores \>/=1 indicate clearing.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Picosecond Q-Switched Nd:YAG 1064/532 nm Laser | Median VAS Improvement Score as Assessed by Blinded Physician Reviewers | 1.5 units on a scale |
p-value: <0.0001Wilcoxon (Mann-Whitney)
Secondary
Mean Pain Score Associated With Laser Treatments
Subjects graded the level of pain associated with each laser treatment, using a 0-10 scale where 0=no pain and 10=worse possible pain, then averaged to get the mean across the treatments.
Time frame: During treatments
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Picosecond Q-Switched Nd:YAG 1064/532 nm Laser | Mean Pain Score Associated With Laser Treatments | 2.0 units on a scale |
Secondary
Percent of Participants Satisfied With Improvement (Clearing) in Solar Lentigines
Level of Satisfaction with Improvement (clearing) in solar lentigines as assessed by participants, as measured by spot Improvement: 3=Very Much Improved, 2=Much Improved, 1=Improved, and 0=No Change.
Time frame: 12 weeks post- final treatment
Population: Based on subject questionnaires, 90% of subjects reported improvement (clearing) in benign pigmented lesions at 12 weeks post- final treatment. Scores \> or =1 indicate improvement.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Picosecond Q-Switched Nd:YAG 1064/532 nm Laser | Percent of Participants Satisfied With Improvement (Clearing) in Solar Lentigines | 95 percent of participants |
Secondary
Percent of Participants With Improvement Score >/=1
Improvement (clearing) in solar lentigines as assessed by participant using a 4-point VAS 0-3 scale where 0=no change and 3=very much improved. Scores \>/=1 indicate improvement.
Time frame: 12 weeks post- final treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Picosecond Q-Switched Nd:YAG 1064/532 nm Laser | Percent of Participants With Improvement Score >/=1 | 90 percent of participants |
Secondary
Percent of Subjects With Post-treatment Adverse Event
Time frame: During study duration 0-6 months.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Picosecond Q-Switched Nd:YAG 1064/532 nm Laser | Percent of Subjects With Post-treatment Adverse Event | Erythema (redness) | 100 percent of participants |
| Picosecond Q-Switched Nd:YAG 1064/532 nm Laser | Percent of Subjects With Post-treatment Adverse Event | Edema (swelling) | 100 percent of participants |
| Picosecond Q-Switched Nd:YAG 1064/532 nm Laser | Percent of Subjects With Post-treatment Adverse Event | Crusting (scabbing) | 100 percent of participants |
| Picosecond Q-Switched Nd:YAG 1064/532 nm Laser | Percent of Subjects With Post-treatment Adverse Event | Purpura (bruising) | 65 percent of participants |
| Picosecond Q-Switched Nd:YAG 1064/532 nm Laser | Percent of Subjects With Post-treatment Adverse Event | Blisters | 15 percent of participants |
| Picosecond Q-Switched Nd:YAG 1064/532 nm Laser | Percent of Subjects With Post-treatment Adverse Event | Eczema | 5 percent of participants |