Acne Scars
Conditions
Brief summary
The purpose of this study to evaluate the SmartLipo Triplex laser system along with the SideLaze800 hand piece in the treatment of Acne Scars.
Interventions
DEVICESmartLipo Triplex laser system along with the SideLaze800 hand piece
Sponsors
Cynosure, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* A healthy male or female between 18 and 65 years old * Has unwanted facial acne scars and wishes to undergo laser treatments. * Is willing to consent to participate in the study. * Is willing to comply with all requirements of the study including being photographed, following post treatment care and attending follow up visits.
Exclusion criteria
* The subject is female and pregnant, has been pregnant within the last 3 months, is currently breast feeding or planning a pregnancy during the study period. * The subject is hypersensitive to light exposure OR takes photo sensitized medication. * The subject has active or localized systemic infections. * The subject 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}). * The subject is currently enrolled in an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within the planned treatment area 3 months prior to entering this study. * The subject has used Accutane within 6 months prior to enrollment. * The subject has the need to be exposed to artificial tanning devices or excessive sunlight during the trial. * The subject has had prior treatment with parenteral gold therapy (gold sodium thiomalate). * The subject has a history of keloids. * The subject has evidence of compromised wound healing. * The subject has a history of squamous cell carcinoma or melanoma. * The subject has a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications. * The subject has an allergy to lidocaine and epinephrine. * The subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Facial Acne Improvement Using the Global Aesthetic Improvement Scale | 3 months post treatment | This assesses the level of improvement of acne scarring using the Global Aesthetic Improvement Scale. It is done through using photographic evaluation, comparing the baseline photograph to a photograph taken 3 months post the last treatment. The options for the acne scarring improvement are very much improved, much improved, improved, no change, or worse. The photographic evaluator decides this improvement based off of scar appearance differences amongst the photographs. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Investigator Satisfaction Questionnaire | 3 months post treatment | The investigator chooses if they are extremely satisfied, satisfied, slightly satisfied, slightly dissatisfied, dissatisfied, or extremely dissatisfied with the results. |
| Subject Satisfaction Questionnaire | 3 months post treatment | The subject chooses if they are extremely satisfied, satisfied, slightly satisfied, slightly dissatisfied, dissatisfied, or extremely dissatisfied with the results. |
Countries
United States
Participant flow
Pre-assignment details
One additional patient was enrolled beyond the limitations specified by the original protocol. The protocol was amended (and approved by the IRB) part way through the study to allow for the enrollment of this additional subject.
Participants by arm
| Arm | Count |
|---|---|
| SmartLipo Triplex Laser System Along With the SideLaze800 Hand SmartLipo Triplex laser system along with the SideLaze800 hand piece | 21 |
| Total | 21 |
Baseline characteristics
| Characteristic | SmartLipo Triplex Laser System Along With the SideLaze800 Hand |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 21 Participants |
| Fitzpatrick Skin Type Fitzpatrick Skin Score I | 0 Participants |
| Fitzpatrick Skin Type Fitzpatrick Skin Score II | 0 Participants |
| Fitzpatrick Skin Type Fitzpatrick Skin Score III | 11 Participants |
| Fitzpatrick Skin Type Fitzpatrick Skin Score IV | 7 Participants |
| Fitzpatrick Skin Type Fitzpatrick Skin Score V | 3 Participants |
| Fitzpatrick Skin Type Fitzpatrick Skin Score VI | 0 Participants |
| Race/Ethnicity, Customized Race/Ethnicity African American | 2 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Asian | 2 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Caucasian | 8 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Hispanic | 5 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Other | 4 Participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 21 |
| other Total, other adverse events | 16 / 21 |
| serious Total, serious adverse events | 0 / 21 |
Outcome results
Primary
Percentage of Participants With Facial Acne Improvement Using the Global Aesthetic Improvement Scale
This assesses the level of improvement of acne scarring using the Global Aesthetic Improvement Scale. It is done through using photographic evaluation, comparing the baseline photograph to a photograph taken 3 months post the last treatment. The options for the acne scarring improvement are very much improved, much improved, improved, no change, or worse. The photographic evaluator decides this improvement based off of scar appearance differences amongst the photographs.
Time frame: 3 months post treatment
Population: 1 subject completed the follow up over the phone, so there is no physician score for this subject. 2 subjects were a no-show for their appointment, but attended the other optional follow ups. The other 4 did not return to follow ups and could not be reached after numerous attempts to follow up.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SmartLipo Triplex Laser System Along With the SideLaze800 Hand | Percentage of Participants With Facial Acne Improvement Using the Global Aesthetic Improvement Scale | Very Much Improved | 28.6 percentage of participants |
| SmartLipo Triplex Laser System Along With the SideLaze800 Hand | Percentage of Participants With Facial Acne Improvement Using the Global Aesthetic Improvement Scale | Much Improved | 57.1 percentage of participants |
| SmartLipo Triplex Laser System Along With the SideLaze800 Hand | Percentage of Participants With Facial Acne Improvement Using the Global Aesthetic Improvement Scale | Improved | 14.3 percentage of participants |
Secondary
Investigator Satisfaction Questionnaire
The investigator chooses if they are extremely satisfied, satisfied, slightly satisfied, slightly dissatisfied, dissatisfied, or extremely dissatisfied with the results.
Time frame: 3 months post treatment
Population: 1 subject completed the follow up over the phone, so there is no physician score for this subject. 2 subjects were a no-show for their appointment, but attended the other optional follow ups. The other 4 did not return to follow ups and could not be reached after numerous attempts to follow up.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SmartLipo Triplex Laser System Along With the SideLaze800 Hand | Investigator Satisfaction Questionnaire | Extremely Satisfied | 6 Participants |
| SmartLipo Triplex Laser System Along With the SideLaze800 Hand | Investigator Satisfaction Questionnaire | Satisfied | 5 Participants |
| SmartLipo Triplex Laser System Along With the SideLaze800 Hand | Investigator Satisfaction Questionnaire | Slightly Satisfied | 3 Participants |
Secondary
Subject Satisfaction Questionnaire
The subject chooses if they are extremely satisfied, satisfied, slightly satisfied, slightly dissatisfied, dissatisfied, or extremely dissatisfied with the results.
Time frame: 3 months post treatment
Population: 2 subjects were a no-show for their appointment, but attended the other optional follow ups. The other 4 did not return to follow ups and could not be reached after numerous attempts to follow up.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SmartLipo Triplex Laser System Along With the SideLaze800 Hand | Subject Satisfaction Questionnaire | Extremely Satisfied | 6 Participants |
| SmartLipo Triplex Laser System Along With the SideLaze800 Hand | Subject Satisfaction Questionnaire | Satisfied | 6 Participants |
| SmartLipo Triplex Laser System Along With the SideLaze800 Hand | Subject Satisfaction Questionnaire | Slightly Satisfied | 2 Participants |
| SmartLipo Triplex Laser System Along With the SideLaze800 Hand | Subject Satisfaction Questionnaire | slightly dissatisfied | 1 Participants |