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Evaluation of the safety and efficacy of the 755nm Alex laser for the treatment of benign pigmented and vascular lesions and scars
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laser Treatment | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 755nm Alex laser | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clearance Based on Photographic Scale | This scale ranges from 0 to 3, where 0 is 0-25% clearance, 1 is 26-50% clearance, 2 is 51-75% clearance and 3 is 76-100% clearance. The baseline picture was compared to a photograph taken at the follow up visit. The number of patients that fell into each category was recorded. | 1 months post last treatment |
| Clearance Based on Photographic Scale | This scale ranges from 0 to 3, where 0 is 0-25% clearance, 1 is 26-50% clearance, 2 is 51-75% clearance and 3 is 76-100% clearance. The baseline picture was compared to a photograph taken at the follow up visit. The number of patients that fell into each category was recorded. | 3 months post last treatment |
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Inclusion Criteria:
4.2 Exclusion Criteria
Subject who will not be photographed or who will not cooperate with the post treatment care and follow up schedule
Hypersensitive to light exposure.
Active localized or systemic infections.
Taking medication for which sunlight is a contraindication.
History of squamous cell carcinoma or melanoma.
History of keloid scarring.
Use of oral isotretinoin (Accutane®) within 12 months of initial treatment or during the course of the study. Note: Skin must regain its normal degree of moisture prior to treatment.
Prior treatment with laser or other devices in treatment area within 3 months
History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications.
Subjects who are pregnant, have been pregnant within the last 3 months, are currently breast feeding or are planning a pregnancy within the study period.
Subjects that the physician determines ineligible based on standard of care treatment.
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| Name | Affiliation | Role |
|---|---|---|
| Patricia Krantz | Cynosure, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laser & Skin Surgery Center of New York | New York | New York | 10016 | United States |
1 subject ID was never assigned, so the # of subjects who started the subject was actually 1 less than what the protocol said.
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| ID | Title | Description |
|---|---|---|
| FG000 | Laser Treatment | 755nm Alex laser |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Laser Treatment | 755nm Alex laser |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Clearance Based on Photographic Scale | This scale ranges from 0 to 3, where 0 is 0-25% clearance, 1 is 26-50% clearance, 2 is 51-75% clearance and 3 is 76-100% clearance. The baseline picture was compared to a photograph taken at the follow up visit. The number of patients that fell into each category was recorded. | 19 subjects were lost to follow up after their treatment. 2 subjects did not have clearance data but had photographs for each of the follow up visits. 4 subjects did not attend the 1 month follow up, but attended a 3 month follow up, so their data was included. 2 subjects were not included in the trial. | Posted | Count of Participants | Participants | 1 months post last treatment |
|
Adverse Events occurring were captured and followed for each patient's participation in the study, approximately 26 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 | Laser Treatment | 755nm Alex laser | 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 |
|---|---|
| D002921 | Cicatrix |
| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Fitzpatrick Skin Score | 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. The scale comes from this source: Gupta, Sharma. Skin typing: Fitzpatrick grading and others. Clinics in Dermatology. 2019;37(5):430-436. doi:10.1016/j.clindermatol.2019.07.010 | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Clearance Based on Photographic Scale | This scale ranges from 0 to 3, where 0 is 0-25% clearance, 1 is 26-50% clearance, 2 is 51-75% clearance and 3 is 76-100% clearance. The baseline picture was compared to a photograph taken at the follow up visit. The number of patients that fell into each category was recorded. | 19 subjects were lost to follow up, 2 subjects did not have clearance data but had photographs for each of the follow up visits. 6 subjects did not have data for this follow up visit but had data for the 1 month follow up visit, so their data were included. 2 subjects were not included in the trial. | Posted | Count of Participants | Participants | 3 months post last treatment |
|
|
|
| 42 |
| 0 |
| 42 |
| 17 |
| 42 |
| Swelling | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Crusting | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Blistering | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Hypopigmentation | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Hyperpigmentation | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Puritis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Infection | Infections and infestations | Systematic Assessment |
|
The PI cannot disclose confidential or proprietary information until after it becomes generally known or available to the public.
| 0-25% |
|