Facial Rejuvenation
Conditions
Brief summary
The purpose of this study is to assess treatment of facial rejuvenation using the standard hand piece and a Lens Array for the 755nm Alexandrite laser.
Interventions
DEVICE755nm Laser with Cap 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. 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 |
|---|---|---|
| Changes in Facial Scarring Score | Baseline and 3 months post last treatment | Physicians will examine the subjects' facial scarring using the Physician Global Scarring Grading (PGSG) scale. This scale counts and types scars by tallying up of the number and severity of the scars 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). |
| Photodamage Score Change | Baseline and 3 months post last treatment | The photodamage is assessed by examining fine wrinkles, mottled hyperpigmentation, and overall integrated assessment of photodamage. These 3 categories are broken down into their own scales of 0 to 4 based on severity. 0 indicates none, 1 indicates minimal, 2 indicates mild, 3 indicates moderate, and 4 indicates severe. The total points from all 3 categories added up will range from 0 to 12, where 12 is the most photodamage possible. A decrease in score indicates less photodamage. |
| Number of Participants With Signs of New Collagen Generations | 3 months post last treatment | Subjects will have one 3mm punch biopsy obtained pretreatment from an inconspicuous area and subsequent biopsies at one or any of the following visits after treatment. Pathologies will be provided by pathologists who are able to determine any developments of dermal mucus, dermal elastic fibers, or changes in collagen III. An increase in any of these categories corresponds with skin rejuvenation. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 755nm Alexandrite Laser With Cap Array- Acne 755nm Laser with Cap Array | 10 |
| 755nm Alexandrite Laser With Cap Array- Photodamage 755nm Laser with Cap Array | 12 |
| 755nm Laser With Cap Array- Biopsy 755nm Laser with Cap Array | 4 |
| Total | 26 |
Baseline characteristics
| Characteristic | Total | 755nm Alexandrite Laser With Cap Array- Acne | 755nm Alexandrite Laser With Cap Array- Photodamage | 755nm Laser With Cap Array- Biopsy |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 25 Participants | 10 Participants | 12 Participants | 3 Participants |
| Fitzpatrick Skin Type Fitzpatrick Skin Type I | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Fitzpatrick Skin Type Fitzpatrick Skin Type II | 4 Participants | 2 Participants | 0 Participants | 2 Participants |
| Fitzpatrick Skin Type Fitzpatrick Skin Type III | 13 Participants | 4 Participants | 8 Participants | 1 Participants |
| Fitzpatrick Skin Type Fitzpatrick Skin Type IV | 8 Participants | 3 Participants | 4 Participants | 1 Participants |
| Fitzpatrick Skin Type Fitzpatrick Skin Type V | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Fitzpatrick Skin Type Fitzpatrick Skin Type VI | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Asian | 5 Participants | 2 Participants | 2 Participants | 1 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Caucasian | 16 Participants | 4 Participants | 9 Participants | 3 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Hispanic | 5 Participants | 4 Participants | 1 Participants | 0 Participants |
| Sex: Female, Male Female | 23 Participants | 10 Participants | 12 Participants | 1 Participants |
| Sex: Female, Male Male | 3 Participants | 0 Participants | 0 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 12 | 0 / 4 |
| other Total, other adverse events | 8 / 11 | 12 / 12 | 0 / 4 |
| serious Total, serious adverse events | 0 / 11 | 0 / 12 | 0 / 4 |
Outcome results
Primary
Changes in Facial Scarring Score
Physicians will examine the subjects' facial scarring using the Physician Global Scarring Grading (PGSG) scale. This scale counts and types scars by tallying up of the number and severity of the scars 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 last treatment
Population: 4 subjects withdrew due to scheduling conflicts, and 1 moved out of state. 1 subject had completed the photoaging scoring sheet instead of the acne scarring scoring sheet for their followup, so their scores are not reported. 1 subject is missing data, so their score cannot be used.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 755nm Alexandrite Laser With Cap Array- Acne | Changes in Facial Scarring Score | -.50 score on a scale | Standard Deviation 1 |
Primary
Number of Participants With Signs of New Collagen Generations
Subjects will have one 3mm punch biopsy obtained pretreatment from an inconspicuous area and subsequent biopsies at one or any of the following visits after treatment. Pathologies will be provided by pathologists who are able to determine any developments of dermal mucus, dermal elastic fibers, or changes in collagen III. An increase in any of these categories corresponds with skin rejuvenation.
Time frame: 3 months post last treatment
Population: 2 other patients had biopsies performed on them, but did not come in for a biopsy follow up.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 755nm Alexandrite Laser With Cap Array- Acne | Number of Participants With Signs of New Collagen Generations | dermal mucus increased | 2 Participants |
| 755nm Alexandrite Laser With Cap Array- Acne | Number of Participants With Signs of New Collagen Generations | dermal elastic fibers increased | 2 Participants |
| 755nm Alexandrite Laser With Cap Array- Acne | Number of Participants With Signs of New Collagen Generations | collagen III increased | 2 Participants |
Primary
Photodamage Score Change
The photodamage is assessed by examining fine wrinkles, mottled hyperpigmentation, and overall integrated assessment of photodamage. These 3 categories are broken down into their own scales of 0 to 4 based on severity. 0 indicates none, 1 indicates minimal, 2 indicates mild, 3 indicates moderate, and 4 indicates severe. The total points from all 3 categories added up will range from 0 to 12, where 12 is the most photodamage possible. A decrease in score indicates less photodamage.
Time frame: Baseline and 3 months post last treatment
Population: 1 subject withdrew from the study due to scheduling conflicts.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 755nm Alexandrite Laser With Cap Array- Acne | Photodamage Score Change | -.363 score on a scale | Standard Deviation 1.2 |