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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 755nm Alexandrite laser with cap array | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 755nm Laser with Cap Array | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. | 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. | 3 months post last treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patricia Krantz | Cynosure, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermatology and Laser Surgery | Sacramento | California | 95819 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31896400 | Background | Gupta V, Sharma VK. Skin typing: Fitzpatrick grading and others. Clin Dermatol. 2019 Sep-Oct;37(5):430-436. doi: 10.1016/j.clindermatol.2019.07.010. Epub 2019 Jul 17. |
| Label | URL |
|---|---|
| This is an explanation of the Fitzpatrick Skin typing that is described in the baseline characteristics section. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 755nm Alexandrite Laser With Cap Array- Acne | 755nm Laser with Cap Array Treatment of acne in the facial region. |
| FG001 | 755nm Alexandrite Laser With Cap Array- Photodamage | 755nm Laser with Cap Array Treatment of photodamage in the facial region. |
| FG002 | 755nm Alexandrite Laser With Cap Array- Biopsy | 755nm Laser with Cap Array Biopsy samples were taken of subjects. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 755nm Alexandrite Laser With Cap Array- Acne | 755nm Laser with Cap Array |
| BG001 | 755nm Alexandrite Laser With Cap Array- Photodamage | 755nm Laser with Cap Array |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | One subject in the acne group withdrew from the study before the first treatment occurred and baseline information was collected. The withdrawal was due to scheduling conflicts. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 3 months post last treatment |
|
Adverse Events occurring will be captured and followed for study duration, approximately 13 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 755nm Alexandrite Laser With Cap Array- Acne | 755nm Laser with Cap Array | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| redness | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jamie Trimper | Cynosure | 800-886-2966 | jamie.trimper@cynosure.com |
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| ID | Term |
|---|---|
| D007834 | Lasers |
| ID | Term |
|---|---|
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
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| BG002 | 755nm Laser With Cap Array- Biopsy | 755nm Laser with Cap Array |
| BG003 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | One subject in the acne group withdrew from the study before the first treatment occurred and baseline information was collected. The withdrawal was due to scheduling conflicts. | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | One subject in the acne group withdrew from the study before the first treatment occurred and baseline information was collected. The withdrawal was due to scheduling conflicts. | Count of Participants | Participants |
|
| Fitzpatrick Skin Type | The Fitzpatrick Skin Score is used to determine skin color. It is a numerical system that classifies skin into six types (Type I, Type II, Type III, Type IV, Type V and Type VI) based on the numerical score achieved (ranging from 0 to 36). The lower the score (and skin type number), the fairer the skin. The higher the score (and skin type number), the more deeply pigmented the skin is. | One subject in the acne group withdrew from the study before the first treatment occurred and baseline information was collected. The withdrawal was due to scheduling conflicts. Additionally, one subject in the acne group did not fill out Fitzpatrick Skin Type. The subject missing this baseline information withdrew from the study before the first treatment occurred due to scheduling conflicts. | Count of Participants | Participants |
|
755nm Laser with Cap Array Treatment of acne in the facial region. |
|
|
| 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. | 1 subject withdrew from the study due to scheduling conflicts. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 3 months post last treatment |
|
|
|
| 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. | 2 other patients had biopsies performed on them, but did not come in for a biopsy follow up. | Posted | Count of Participants | Participants | 3 months post last treatment |
|
|
|
| 11 |
| 0 |
| 11 |
| 8 |
| 11 |
| EG001 | 755nm Alexandrite Laser With Cap Array- Photodamage | 755nm Laser with Cap Array | 0 | 12 | 0 | 12 | 12 | 12 |
| EG002 | 755nm Alexandrite Laser With Cap Array- Biopsy | 755nm Laser with Cap Array | 0 | 4 | 0 | 4 | 0 | 4 |
| edema | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Pinpoint Bleeding | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Swelling | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Acne breakout | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
The PI cannot disclose confidential or proprietary information until after it becomes generally known or available to the public.
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
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| Hispanic |
|
| Asian |
|
| Fitzpatrick Skin Type II |
|
| Fitzpatrick Skin Type III |
|
| Fitzpatrick Skin Type IV |
|
| Fitzpatrick Skin Type V |
|
| Fitzpatrick Skin Type VI |
|
| Title | Measurements |
|---|---|
|