An interventional study of 755nm Laser with Cap Array in Facial Rejuvenation, sponsored by Cynosure, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-01-20.
Sponsored by Cynosure, Inc. · Not applicable, Interventional, and Treatment
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.
217 studies on the registry are indexed under Facies; 35 are open to participants now.
This study's enrollment of 27 is below the median of 40 across 161 interventional studies indexed under Facies.
Browse Facies studies →Cynosure, Inc. is the lead sponsor of 52 studies on the registry; 2 are open to participants now.
Of its 21 completed or terminated interventional studies of FDA-regulated products, 16 (76%) have results posted.
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Exclusion Criteria:
Device: 755nm Laser with Cap Array
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
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
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
| Milestone | 755nm Alexandrite Laser With Cap Array- Acne | 755nm Alexandrite Laser With Cap Array- Photodamage | 755nm Alexandrite Laser With Cap Array- Biopsy |
|---|---|---|---|
| Started | 11 | 12 | 4 |
| Completed | 6 | 11 | 4 |
| Not completed | 5 | 1 | 0 |
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).
| score on a scale | 755nm Alexandrite Laser With Cap Array- Acne |
|---|---|
| Changes in Facial Scarring Score | -.50 ± 1 |
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.
| score on a scale | 755nm Alexandrite Laser With Cap Array- Photodamage |
|---|---|
| Photodamage Score Change | -.363 ± 1.20 |
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.
| Participants | 755nm Alexandrite Laser With Cap Array- Biopsy |
|---|---|
| dermal mucus increased | 2 |
| dermal elastic fibers increased | 2 |
| collagen III increased | 2 |
Collected over Adverse Events occurring will be captured and followed for study duration, approximately 13 months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 755nm Alexandrite Laser With Cap Array- Acne | 0/11 (0%) | 0/11 (0%) | 8/11 (72.7%) |
| 755nm Alexandrite Laser With Cap Array- Photodamage | 0/12 (0%) | 0/12 (0%) | 12/12 (100%) |
| 755nm Alexandrite Laser With Cap Array- Biopsy | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) |
| Event | 755nm Alexandrite Laser With Cap Array- Acne | 755nm Alexandrite Laser With Cap Array- Photodamage | 755nm Alexandrite Laser With Cap Array- Biopsy |
|---|---|---|---|
| rednessSkin and subcutaneous tissue disorders | 8/11 | 12/12 | 0/4 |
| edemaSkin and subcutaneous tissue disorders | 8/11 | 12/12 | 0/4 |
| Pinpoint BleedingSkin and subcutaneous tissue disorders | 1/11 | 0/12 | 0/4 |
| SwellingSkin and subcutaneous tissue disorders | 1/11 | 0/12 | 0/4 |
| Acne breakoutSkin and subcutaneous tissue disorders | 1/11 | 0/12 | 0/4 |
| Age, Categorical(Participants) | 755nm Alexandrite Laser With Cap Array- Acne | 755nm Alexandrite Laser With Cap Array- Photodamage | 755nm Laser With Cap Array- Biopsy | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 10 | 12 | 3 | 25 |
| >=65 years | 0 | 0 | 1 | 1 |
| Sex: Female, Male(Participants) | 755nm Alexandrite Laser With Cap Array- Acne | 755nm Alexandrite Laser With Cap Array- Photodamage | 755nm Laser With Cap Array- Biopsy | Total |
|---|---|---|---|---|
| Female | 10 | 12 | 1 | 23 |
| Male | 0 | 0 | 3 | 3 |
| Race/Ethnicity, Customized(Participants) | 755nm Alexandrite Laser With Cap Array- Acne | 755nm Alexandrite Laser With Cap Array- Photodamage | 755nm Laser With Cap Array- Biopsy | Total |
|---|---|---|---|---|
| Race/Ethnicity — Caucasian | 4 | 9 | 3 | 16 |
| Race/Ethnicity — Hispanic | 4 | 1 | 0 | 5 |
| Race/Ethnicity — Asian | 2 | 2 | 1 | 5 |
| Fitzpatrick Skin Type(Participants) | 755nm Alexandrite Laser With Cap Array- Acne | 755nm Alexandrite Laser With Cap Array- Photodamage | 755nm Laser With Cap Array- Biopsy | Total |
|---|---|---|---|---|
| Fitzpatrick Skin Type I | 0 | 0 | 0 | 0 |
| Fitzpatrick Skin Type II | 2 | 0 | 2 | 4 |
| Fitzpatrick Skin Type III | 4 | 8 | 1 | 13 |
| Fitzpatrick Skin Type IV | 3 | 4 | 1 | 8 |
| Fitzpatrick Skin Type V | 0 | 0 | 0 | 0 |
| Fitzpatrick Skin Type VI | 0 | 0 | 0 | 0 |
This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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Cynosure, Inc.