Benign Pigmented and Vascular Lesions and Scars
Conditions
Brief summary
Evaluation of the safety and efficacy of the 755nm Alex laser for the treatment of benign pigmented and vascular lesions and scars
Interventions
DEVICE755nm Alex laser
Sponsors
Cynosure, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy male or female subjects between 18 and 85 years of age. 2. Subjects with Fitzpatrick skin types I to VI. 3. Subjects who have unwanted pigmented lesions, vascular lesions, striae and/or hypertrophic or atrophic scars 4. Subject who are willing to consent to participate in the study. 4.2
Exclusion criteria
1. Subject who will not be photographed or who will not cooperate with the post treatment care and follow up schedule 2. Hypersensitive to light exposure. 3. Active localized or systemic infections. 4. Taking medication for which sunlight is a contraindication. 5. History of squamous cell carcinoma or melanoma. 6. History of keloid scarring. 7. Use of oral isotretinoin (Accutane®) within 12 months of initial treatment or during the course of the study. Note: Skin must regain its normal degree of moisture prior to treatment. 8. Prior treatment with laser or other devices in treatment area within 3 months 9. History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications. 10. Subjects who are pregnant, have been pregnant within the last 3 months, are currently breast feeding or are planning a pregnancy within the study period. 11. Subjects that the physician determines ineligible based on standard of care treatment. \- \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clearance Based on Photographic Scale | 1 months post last treatment | This scale ranges from 0 to 3, where 0 is 0-25% clearance, 1 is 26-50% clearance, 2 is 51-75% clearance and 3 is 76-100% clearance. The baseline picture was compared to a photograph taken at the follow up visit. The number of patients that fell into each category was recorded. |
Countries
United States
Participant flow
Pre-assignment details
1 subject ID was never assigned, so the # of subjects who started the subject was actually 1 less than what the protocol said.
Participants by arm
| Arm | Count |
|---|---|
| Laser Treatment 755nm Alex laser | 42 |
| Total | 42 |
Baseline characteristics
| Characteristic | Laser Treatment |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 41 Participants |
| Fitzpatrick Skin Score Fitzpatrick Skin Type I | 4 Participants |
| Fitzpatrick Skin Score Fitzpatrick Skin Type II | 14 Participants |
| Fitzpatrick Skin Score Fitzpatrick Skin Type III | 14 Participants |
| Fitzpatrick Skin Score Fitzpatrick Skin Type IV | 6 Participants |
| Fitzpatrick Skin Score Fitzpatrick Skin Type V | 3 Participants |
| Fitzpatrick Skin Score Fitzpatrick Skin Type VI | 1 Participants |
| Race/Ethnicity, Customized Race/Ethnicity African American | 2 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Asian | 6 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Caucasian | 24 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Hispanic | 9 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Hispanic/Other | 1 Participants |
| Sex: Female, Male Female | 36 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 42 |
| other Total, other adverse events | 17 / 42 |
| serious Total, serious adverse events | 0 / 42 |
Outcome results
Primary
Clearance Based on Photographic Scale
This scale ranges from 0 to 3, where 0 is 0-25% clearance, 1 is 26-50% clearance, 2 is 51-75% clearance and 3 is 76-100% clearance. The baseline picture was compared to a photograph taken at the follow up visit. The number of patients that fell into each category was recorded.
Time frame: 1 months post last treatment
Population: 19 subjects were lost to follow up after their treatment. 2 subjects did not have clearance data but had photographs for each of the follow up visits. 4 subjects did not attend the 1 month follow up, but attended a 3 month follow up, so their data was included. 2 subjects were not included in the trial.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Laser Treatment | Clearance Based on Photographic Scale | >75% | 2 Participants |
| Laser Treatment | Clearance Based on Photographic Scale | 51-74% | 2 Participants |
| Laser Treatment | Clearance Based on Photographic Scale | 26-50% | 4 Participants |
| Laser Treatment | Clearance Based on Photographic Scale | 0-25% | 7 Participants |
Primary
Clearance Based on Photographic Scale
This scale ranges from 0 to 3, where 0 is 0-25% clearance, 1 is 26-50% clearance, 2 is 51-75% clearance and 3 is 76-100% clearance. The baseline picture was compared to a photograph taken at the follow up visit. The number of patients that fell into each category was recorded.
Time frame: 3 months post last treatment
Population: 19 subjects were lost to follow up, 2 subjects did not have clearance data but had photographs for each of the follow up visits. 6 subjects did not have data for this follow up visit but had data for the 1 month follow up visit, so their data were included. 2 subjects were not included in the trial.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Laser Treatment | Clearance Based on Photographic Scale | >75% | 2 Participants |
| Laser Treatment | Clearance Based on Photographic Scale | 51-74% | 2 Participants |
| Laser Treatment | Clearance Based on Photographic Scale | 26-50% | 4 Participants |
| Laser Treatment | Clearance Based on Photographic Scale | 0-25% | 5 Participants |