Facial Solar Lentigines
Conditions
Brief summary
The purpose of this study is to evaluate the effects of the Revlite Laser System for treatment of facial solar lentigines
Detailed description
Prospective facial study using the revlite laser to treat pigmentation caused by sun damage.
Interventions
DEVICERevlite Laser System
Revlite Laser System for the Treatment of Facial Solar Lentigines
Sponsors
Cynosure, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Intervention model description
Each patient receives a single wavelength treatment on one side of their face, and a double wavelength on the other side of their face.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Is a healthy male or female between 18 and 60 years old. 2. Is Fitzpatrick Skin types I-III 3. Is willing to consent to participate in the study. 4. Is willing to comply with all requirements of the study including being photographed, following post treatment care and attending all treatment and follow up visits. 5. Has clinically determined mild to severe facial mottled pigmentation (solar lentigines) on the face.
Exclusion criteria
1. Is female and pregnant, has been pregnant within the last 3 months, is currently breast feeding or planning a pregnancy during the study period. 2. Is hypersensitive to light exposure OR takes photo sensitized medication. 3. Has active or localized systemic infections. 4. Has a coagulation disorder or is currently using anti-coagulation medication (including but not limited to the heavy use of aspirin {greater than 81 mg per day}). 5. Has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study. 6. Is currently enrolled in an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within 3 months prior to entering this study. 7. Has used Accutane within 6 months prior to enrollment. 8. Has the need to be exposed to artificial tanning devices or excessive sunlight during the trial. 9. Has had prior treatment with parenteral gold therapy (gold sodium thiomalate). 10. Has a history of keloids. 11. Has evidence of compromised wound healing. 12. Has a history of basal cell carcinoma, squamous cell carcinoma or melanoma. 13. Has a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications or has an autoimmune disorder.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Photographic Evaluation Using the Blinded Global Aesthetic Improvement Scale | 1 month post last treatment | Photos taken at baseline will be compared to photos taken 1 month post last treatment to assess the level of improvement using the Global Aesthetic Improvement Scale. This evaluation is blinded. This scale ranges from -1 to 3, where -1 is worsened, 0 is no change, 1 is improved, 2 is much improved, and 3 is very much improved. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physician Satisfaction Questionnaire | 1 month post last treatment | The satisfaction is on a scale ranging from extremely satisfied (6) to extremely dissatisfied (1). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Revlite Laser System Revlite Laser System
Revlite Laser System: Revlite Laser System for the Treatment of Facial Solar Lentigines | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Revlite Laser System |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants |
| Fitzpatrick Skin Score Fitzpatrick Skin Type I | 1 Participants |
| Fitzpatrick Skin Score Fitzpatrick Skin Type II | 7 Participants |
| Fitzpatrick Skin Score Fitzpatrick Skin Type III | 2 Participants |
| Fitzpatrick Skin Score Fitzpatrick Skin Type IV | 0 Participants |
| Fitzpatrick Skin Score Fitzpatrick Skin Type V | 0 Participants |
| Fitzpatrick Skin Score Fitzpatrick Skin Type VI | 0 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Caucasian | 8 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Hispanic | 2 Participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 9 / 10 | 9 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
Primary
Photographic Evaluation Using the Blinded Global Aesthetic Improvement Scale
Photos taken at baseline will be compared to photos taken 1 month post last treatment to assess the level of improvement using the Global Aesthetic Improvement Scale. This evaluation is blinded. This scale ranges from -1 to 3, where -1 is worsened, 0 is no change, 1 is improved, 2 is much improved, and 3 is very much improved.
Time frame: 1 month post last treatment
Population: Since all subjects who enrolled received at least 1 treatment and had a 30 day follow up to this treatment, all subject information is included. The time frame is based off of the follow up to each subject's final treatment.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Revlite Laser System Single | Photographic Evaluation Using the Blinded Global Aesthetic Improvement Scale | Much Improved | 3 Participants |
| Revlite Laser System Single | Photographic Evaluation Using the Blinded Global Aesthetic Improvement Scale | No Change | 1 Participants |
| Revlite Laser System Single | Photographic Evaluation Using the Blinded Global Aesthetic Improvement Scale | Improved | 6 Participants |
| Revlite Laser System Single | Photographic Evaluation Using the Blinded Global Aesthetic Improvement Scale | Worse | 0 Participants |
| Revlite Laser System Single | Photographic Evaluation Using the Blinded Global Aesthetic Improvement Scale | Very Much Improved | 0 Participants |
| Revlite Laser System- Combo | Photographic Evaluation Using the Blinded Global Aesthetic Improvement Scale | Worse | 0 Participants |
| Revlite Laser System- Combo | Photographic Evaluation Using the Blinded Global Aesthetic Improvement Scale | Very Much Improved | 1 Participants |
| Revlite Laser System- Combo | Photographic Evaluation Using the Blinded Global Aesthetic Improvement Scale | Much Improved | 3 Participants |
| Revlite Laser System- Combo | Photographic Evaluation Using the Blinded Global Aesthetic Improvement Scale | Improved | 4 Participants |
| Revlite Laser System- Combo | Photographic Evaluation Using the Blinded Global Aesthetic Improvement Scale | No Change | 2 Participants |
Secondary
Physician Satisfaction Questionnaire
The satisfaction is on a scale ranging from extremely satisfied (6) to extremely dissatisfied (1).
Time frame: 1 month post last treatment
Population: Since all subjects who enrolled received at least 1 treatment and had a 30 day follow up to this treatment, all subject information is included. The time frame is based off of the follow up to each subject's final treatment.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Revlite Laser System Single | Physician Satisfaction Questionnaire | 3.70 score on a scale | Standard Deviation 1.63 |
| Revlite Laser System- Combo | Physician Satisfaction Questionnaire | 3.600 score on a scale | Standard Deviation 1.65 |