Striae
Conditions
Brief summary
Evaluate the safety and efficacy of the bilateral treatment of striae using a 755nm Alexandrite laser.
Interventions
DEVICE755nm Alexandrite Laser
755nm Alexandrite laser with array handpiece
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 striae 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 Striae Clearance | Follow Up Between 1 and 3 Months Post Last Treatment | The physician will judge the overall improvement by selecting from improvement ranges of 0-25%, 25-50%, 50-75%, or 75-100% clearance when compared to the baseline. |
Countries
United States
Participant flow
Pre-assignment details
Each patient's striation area was treated with the array handpiece. No patients were treated with the standard handpiece.
Participants by arm
| Arm | Count |
|---|---|
| 755nm Alexandrite Laser 755nm Alexandrite laser (standard handpiece)
755nm Alexandrite Laser: 755nm Alexandrite laser with modified and standard handpiece | 45 |
| Total | 45 |
Baseline characteristics
| Characteristic | 755nm Alexandrite Laser |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 45 Participants |
| Fitzpatrick Skin Score Fitzpatrick Skin Score I | 4 Participants |
| Fitzpatrick Skin Score Fitzpatrick Skin Score II | 9 Participants |
| Fitzpatrick Skin Score Fitzpatrick Skin Score III | 17 Participants |
| Fitzpatrick Skin Score Fitzpatrick Skin Score IV | 9 Participants |
| Fitzpatrick Skin Score Fitzpatrick Skin Score V | 2 Participants |
| Fitzpatrick Skin Score Fitzpatrick Skin Score VI | 4 Participants |
| Race/Ethnicity, Customized Race/Ethnicity African American | 6 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Asian | 5 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Caucasian | 24 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Hispanic | 9 Participants |
| Race/Ethnicity, Customized Race/Ethnicity W. Indian | 1 Participants |
| Sex: Female, Male Female | 40 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 45 |
| other Total, other adverse events | 26 / 45 |
| serious Total, serious adverse events | 0 / 45 |
Outcome results
Primary
Photographic Evaluation of Striae Clearance
The physician will judge the overall improvement by selecting from improvement ranges of 0-25%, 25-50%, 50-75%, or 75-100% clearance when compared to the baseline.
Time frame: Follow Up Between 1 and 3 Months Post Last Treatment
Population: 5 subject withdrew and 13 were lost to follow up.
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| 755nm Alexandrite Laser With Array Handpiece | Photographic Evaluation of Striae Clearance | 0-25% Improvement from Baseline | 36 areas with striation |
| 755nm Alexandrite Laser With Array Handpiece | Photographic Evaluation of Striae Clearance | 25-50% Improvement from Baseline | 17 areas with striation |
| 755nm Alexandrite Laser With Array Handpiece | Photographic Evaluation of Striae Clearance | 50-75% Improvement from Baseline | 11 areas with striation |