Scars
Conditions
Brief summary
Evaluate the safety and efficacy of removing unwanted scars using a 755nm Alexandrite laser.
Interventions
DEVICE755nm Alexandrite Laser
755nm Alexandrite 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
No
Inclusion criteria
1. Is a healthy male or female between 18 and 85 years old. 2. Has unwanted scars (including atrophic, hypertrophic, hyper or hypo pigmented, erythematous )and wishes to undergo laser treatments to remove or improve them. 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
Exclusion criteria
1. Is hypersensitive to light exposure. 2. Has active localized or systemic infection. 3. Is taking medication(s) for which sunlight is a contraindication. 4. Has a history of squamous cell carcinoma or melanoma. 5. Has a history of keloid scarring. 6. Has used oral isotretinoin (Accutane®) within 12 months of initial treatment or plans on using during the course of the study. Note: Skin must regain its normal degree of moisture prior to treatment. 7. Has a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications. 8. Is female and pregnant, has been pregnant within the last 3 months, is currently breast feeding or planning a pregnancy during the study period. 9. Is allergic to lidocaine, tetracaine or Xylocaine with epinephrine. 10. Has any other reason determined by the physician to be ineligible to participate in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Photographic Evaluation of Scar Clearance | 1 Month Post Last Treatment | The échelle d'évaluation clinique des cicatrices d'acné (ECCA) Grading scale was used to evaluate the photographs, using 2D and 3D photography, where the scale ranges from 0 to 4. 0 represents 0% improvement/worse, 1 is 1-25% improvement, 2 is 26-50% improvement, 3 is 51-74% improvement, and 4 is \>75% improvement. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 755nm Alexandrite Laser 755nm Alexandrite Laser
755nm Alexandrite Laser: 755nm Alexandrite Laser | 33 |
| Total | 33 |
Baseline characteristics
| Characteristic | 755nm Alexandrite Laser |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 32 Participants |
| Fitzpatrick Skin Type Fitzpatrick Skin Type I | 2 Participants |
| Fitzpatrick Skin Type Fitzpatrick Skin Type II | 12 Participants |
| Fitzpatrick Skin Type Fitzpatrick Skin Type III | 9 Participants |
| Fitzpatrick Skin Type Fitzpatrick Skin Type IV | 4 Participants |
| Fitzpatrick Skin Type Fitzpatrick Skin Type V | 4 Participants |
| Fitzpatrick Skin Type Fitzpatrick Skin Type VI | 2 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Asian | 4 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Black | 6 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Caucasian | 21 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Hispanic | 2 Participants |
| Sex: Female, Male Female | 25 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 33 |
| other Total, other adverse events | 17 / 33 |
| serious Total, serious adverse events | 0 / 33 |
Outcome results
Primary
Photographic Evaluation of Scar Clearance
The échelle d'évaluation clinique des cicatrices d'acné (ECCA) Grading scale was used to evaluate the photographs, using 2D and 3D photography, where the scale ranges from 0 to 4. 0 represents 0% improvement/worse, 1 is 1-25% improvement, 2 is 26-50% improvement, 3 is 51-74% improvement, and 4 is \>75% improvement.
Time frame: 1 Month Post Last Treatment
Population: 7 subjects were lost to follow up. 3 subjects withdrew. 1 subject cancelled multiple appointments and could not come in.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 755nm Alexandrite Laser | Photographic Evaluation of Scar Clearance | 1.82 score on a scale | Standard Deviation 0.73 |
Primary
Photographic Evaluation of Scar Clearance
The échelle d'évaluation clinique des cicatrices d'acné (ECCA) Grading scale was used to evaluate the photographs, using 2D and 3D photography, where the scale ranges from 0 to 4. 0 represents 0% improvement/worse, 1 is 1-25% improvement, 2 is 26-50% improvement, 3 is 51-74% improvement, and 4 is \>75% improvement.
Time frame: 3 Months Post Last Treatment
Population: 9 subjects were lost to follow up. 3 subjects withdrew. 1 subject was not done due to patient's non-compliance. 2 subjects did not record overall clearance for this follow up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 755nm Alexandrite Laser | Photographic Evaluation of Scar Clearance | 2.28 score on a scale | Standard Deviation 0.75 |