Acne Scars
Conditions
Brief summary
The purpose of this study is to assess treatment of facial acne scars using the 755nm Alexandrite Laser with lens arrays.
Interventions
DEVICE755nm Alexandrite laser with lens array
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
1. Is a healthy male or female between 18 and 65 years old 2. Has unwanted acne scars, excluding ice pick scars (Deep atrophic scars that resemble poked holes), and wishes to undergo laser treatments. 3. Is willing to consent to participate in the study. 4. Is willing to comply with all requirements of the study including biopsies, being photographed, following post treatment care and attending all treatment and follow up visits.
Exclusion criteria
1. 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. 2. The subject is hypersensitive to light exposure OR takes photo sensitized medication. 3. The subject has active or localized systemic infections. 4. The subject has a coagulation disorder or is currently using anti-coagulation medication (including but not limited to heavy aspirin therapy {greater than 81 mg per day}). 5. The subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study. 6. 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 3 months prior to entering this study. 7. The subject has used Accutane within 6 months prior to enrollment. 8. The subject has the need to be exposed to artificial tanning devices or excessive sunlight during the trial. 9. The subject has had prior treatment with parenteral gold therapy (gold sodium thiomalate). 10. The subject has a history of keloids. 11. The subject has evidence of compromised wound healing. 12. The subject has a history of squamous cell carcinoma or melanoma. 13. The subject has a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications. 14. The subject has an allergy to lidocaine and epinephrine.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Severity Change in Acne Scarring | Baseline and 1 month post treatment | The scale is a Physician Global Scarring Grading Scale, which counts and types scars by tallying up of the number and severity according to an organized grading system, where 0 is the lowest point value and represents no scarring. The theoretical highest score possible is an 84. The change in the score from the baseline to the follow up was collected. A negative change indicates a decrease in points (which indicates improvement). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Investigator Satisfaction Questionnaire | 3 months post treatment | Investigator will complete satisfaction questionnaire at follow up visits from 0 to 3, where 0 is extremely dissatisfied and 3 is extremely satisfied. |
| Subject Satisfaction Questionnaire | 3 months post treatment | Subject will complete satisfaction questionnaire at follow up visits from 0 to 3, where 0 is extremely dissatisfied and 3 is extremely satisfied. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 755nm Alexandrite Laser With Lens Array 755nm Alexandrite laser with lens array | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | 755nm Alexandrite Laser With Lens Array |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants |
| Fitzpatrick Skin Type Fitzpatrick Skin Score I | 0 Participants |
| Fitzpatrick Skin Type Fitzpatrick Skin Score II | 13 Participants |
| Fitzpatrick Skin Type Fitzpatrick Skin Score III | 3 Participants |
| Fitzpatrick Skin Type Fitzpatrick Skin Score IV | 4 Participants |
| Fitzpatrick Skin Type Fitzpatrick Skin Score V | 0 Participants |
| Fitzpatrick Skin Type Fitzpatrick Skin Score VI | 0 Participants |
| Race/Ethnicity, Customized Race/Ethnicity African American | 0 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Asian | 0 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Caucasian | 16 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Hispanic | 3 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Other | 1 Participants |
| Sex: Female, Male Female | 19 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 17 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Severity Change in Acne Scarring
The scale is a Physician Global Scarring Grading Scale, which counts and types scars by tallying up of the number and severity according to an organized grading system, where 0 is the lowest point value and represents no scarring. The theoretical highest score possible is an 84. The change in the score from the baseline to the follow up was collected. A negative change indicates a decrease in points (which indicates improvement).
Time frame: Baseline and 1 month post treatment
Population: 1 subject was pregnant, 1 subject was lost to follow up, and 1 subject withdrew consent. 3 subjects missed their visits.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 755nm Alexandrite Laser With Lens Array | Severity Change in Acne Scarring | -2 score on a scale | Standard Deviation 2.71 |
Primary
Severity Change in Acne Scarring
The scale is a Physician Global Scarring Grading Scale, which counts and types scars by tallying up of the number and severity according to an organized grading system, where 0 is the lowest point value and represents no scarring. The theoretical highest score possible is an 84. The change in the score from the baseline to the follow up was collected. A negative change indicates a decrease in points (which indicates improvement).
Time frame: Baseline and 3 months post treatment
Population: 1 subject was pregnant, 1 subject was lost to follow up, and 1 subject withdrew consent.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 755nm Alexandrite Laser With Lens Array | Severity Change in Acne Scarring | -1 score on a scale | Standard Deviation 3.15 |
Secondary
Investigator Satisfaction Questionnaire
Investigator will complete satisfaction questionnaire at follow up visits from 0 to 3, where 0 is extremely dissatisfied and 3 is extremely satisfied.
Time frame: 3 months post treatment
Population: 1 subject was pregnant, 1 subject was lost to follow up, and 1 subject withdrew consent.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 755nm Alexandrite Laser With Lens Array | Investigator Satisfaction Questionnaire | Extremely Satisfied | 0 participants |
| 755nm Alexandrite Laser With Lens Array | Investigator Satisfaction Questionnaire | Satisfied | 10 participants |
| 755nm Alexandrite Laser With Lens Array | Investigator Satisfaction Questionnaire | Dissatisfied | 7 participants |
| 755nm Alexandrite Laser With Lens Array | Investigator Satisfaction Questionnaire | Extremely Dissatisfied | 0 participants |
Secondary
Subject Satisfaction Questionnaire
Subject will complete satisfaction questionnaire at follow up visits from 0 to 3, where 0 is extremely dissatisfied and 3 is extremely satisfied.
Time frame: 3 months post treatment
Population: 1 subject was pregnant, 1 subject was lost to follow up, and 1 subject withdrew consent.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 755nm Alexandrite Laser With Lens Array | Subject Satisfaction Questionnaire | Extremely Satisfied | 3 participants |
| 755nm Alexandrite Laser With Lens Array | Subject Satisfaction Questionnaire | Satisfied | 11 participants |
| 755nm Alexandrite Laser With Lens Array | Subject Satisfaction Questionnaire | Dissatisfied | 3 participants |
| 755nm Alexandrite Laser With Lens Array | Subject Satisfaction Questionnaire | Extremely Dissatisfied | 0 participants |