Wrinkles
Conditions
Brief summary
The purpose of this study is to evaluate the efficacy and safety of the treatment of wrinkles using the picosecond 755nm Alexandrite laser.
Interventions
DEVICE755nm Alexandrite laser
755nm Alexandrite laser for the treatment of wrinkles
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 non-smoking (must have quit 1 year prior) male or female between 18 and 65 years old. 2. Is willing to consent to participate in the study. 3. 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 |
|---|---|---|
| Photographic Evaluation of Wrinkle Severity at Baseline | Baseline | Blinded evaluators grade photographs using the Fitzpatrick wrinkle severity scale and provide an overall score for each timepoint. The Fitzpatrick wrinkle scale classifies wrinkles on a scale from 1 (mild) to 9 (severe). |
| Photographic Evaluation of Wrinkle Severity at 1 Month Follow Up | 1 Month Follow Up Post Last Treatment | Blinded evaluators grade photographs using the Fitzpatrick wrinkle severity scale and provide an overall score for each timepoint. The Fitzpatrick wrinkle scale classifies wrinkles on a scale from 1 (mild) to 9 (severe). |
| Photographic Evaluation of Wrinkle Severity at 3 Month Follow Up | 3 Month Follow Up Post Last Treatment | Blinded evaluators grade photographs using the Fitzpatrick wrinkle severity scale and provide an overall score for each timepoint. The Fitzpatrick wrinkle scale classifies wrinkles on a scale from 1 (mild) to 9 (severe). |
| Photographic Evaluation of Wrinkle Severity at 4 Month Follow Up | 4 months post last treatment | Blinded evaluators grade photographs using the Fitzpatrick wrinkle severity scale and provide an overall score for each timepoint. The Fitzpatrick wrinkle scale classifies wrinkles on a scale from 1 (mild) to 9 (severe). |
| Photographic Evaluation of Wrinkle Severity at 6 Month Follow Up | 6 months post last treatment | Blinded evaluators grade photographs using the Fitzpatrick wrinkle severity scale and provide an overall score for each timepoint. The Fitzpatrick wrinkle scale classifies wrinkles on a scale from 1 (mild) to 9 (severe). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 755nm Alexandrite Laser 755nm Alexandrite laser for the treatment of wrinkles
755nm Alexandrite laser: 755nm Alexandrite laser for the treatment of wrinkles | 20 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 2 |
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 | 20 Participants |
| Fitzpatrick Skin Type I | 0 Participants |
| Fitzpatrick Skin Type II | 7 Participants |
| Fitzpatrick Skin Type III | 11 Participants |
| Fitzpatrick Skin Type IV | 2 Participants |
| Fitzpatrick Skin Type V | 0 Participants |
| Fitzpatrick Skin Type VI | 0 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Asian | 0 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Black | 0 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Caucasian | 20 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Hispanic | 0 Participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Photographic Evaluation of Wrinkle Severity at 1 Month Follow Up
Blinded evaluators grade photographs using the Fitzpatrick wrinkle severity scale and provide an overall score for each timepoint. The Fitzpatrick wrinkle scale classifies wrinkles on a scale from 1 (mild) to 9 (severe).
Time frame: 1 Month Follow Up Post Last Treatment
Population: One subject did not show up to their follow up appointment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 755nm Alexandrite Laser | Photographic Evaluation of Wrinkle Severity at 1 Month Follow Up | 3 score on a scale | Standard Deviation 1.25 |
Primary
Photographic Evaluation of Wrinkle Severity at 3 Month Follow Up
Blinded evaluators grade photographs using the Fitzpatrick wrinkle severity scale and provide an overall score for each timepoint. The Fitzpatrick wrinkle scale classifies wrinkles on a scale from 1 (mild) to 9 (severe).
Time frame: 3 Month Follow Up Post Last Treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 755nm Alexandrite Laser | Photographic Evaluation of Wrinkle Severity at 3 Month Follow Up | 3 score on a scale | Standard Deviation 1.28 |
Primary
Photographic Evaluation of Wrinkle Severity at 4 Month Follow Up
Blinded evaluators grade photographs using the Fitzpatrick wrinkle severity scale and provide an overall score for each timepoint. The Fitzpatrick wrinkle scale classifies wrinkles on a scale from 1 (mild) to 9 (severe).
Time frame: 4 months post last treatment
Population: 2 subjects did not show up for their follow ups.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 755nm Alexandrite Laser | Photographic Evaluation of Wrinkle Severity at 4 Month Follow Up | 3 score on a scale | Standard Deviation 1.11 |
Primary
Photographic Evaluation of Wrinkle Severity at 6 Month Follow Up
Blinded evaluators grade photographs using the Fitzpatrick wrinkle severity scale and provide an overall score for each timepoint. The Fitzpatrick wrinkle scale classifies wrinkles on a scale from 1 (mild) to 9 (severe).
Time frame: 6 months post last treatment
Population: 2 subjects did not show up for their follow ups.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 755nm Alexandrite Laser | Photographic Evaluation of Wrinkle Severity at 6 Month Follow Up | 3 score on a scale | Standard Error 1.23 |
Primary
Photographic Evaluation of Wrinkle Severity at Baseline
Blinded evaluators grade photographs using the Fitzpatrick wrinkle severity scale and provide an overall score for each timepoint. The Fitzpatrick wrinkle scale classifies wrinkles on a scale from 1 (mild) to 9 (severe).
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 755nm Alexandrite Laser | Photographic Evaluation of Wrinkle Severity at Baseline | 5.7 score on a scale | Standard Deviation 0.8 |