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Evaluate the safety and efficacy of removing unwanted scars using a 755nm Alexandrite laser.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 755nm Alexandrite Laser | Experimental | 755nm Alexandrite Laser |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 755nm Alexandrite Laser | Device | 755nm Alexandrite Laser |
|
| Measure | Description | Time Frame |
|---|---|---|
| Photographic Evaluation of Scar Clearance | The échelle d'évaluation clinique des cicatrices d'acné (ECCA) Grading scale was used to evaluate the photographs, using 2D and 3D photography, where the scale ranges from 0 to 4. 0 represents 0% improvement/worse, 1 is 1-25% improvement, 2 is 26-50% improvement, 3 is 51-74% improvement, and 4 is >75% improvement. | 1 Month Post Last Treatment |
| Photographic Evaluation of Scar Clearance | The échelle d'évaluation clinique des cicatrices d'acné (ECCA) Grading scale was used to evaluate the photographs, using 2D and 3D photography, where the scale ranges from 0 to 4. 0 represents 0% improvement/worse, 1 is 1-25% improvement, 2 is 26-50% improvement, 3 is 51-74% improvement, and 4 is >75% improvement. | 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 |
|---|---|---|---|---|---|---|
| Laser & Skin Surgery Center of New York | New York | New York | 10016 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 755nm Alexandrite Laser | 755nm Alexandrite Laser 755nm Alexandrite Laser: 755nm Alexandrite Laser |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 755nm Alexandrite Laser | 755nm Alexandrite Laser 755nm Alexandrite Laser: 755nm Alexandrite 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 | Photographic Evaluation of Scar Clearance | The échelle d'évaluation clinique des cicatrices d'acné (ECCA) Grading scale was used to evaluate the photographs, using 2D and 3D photography, where the scale ranges from 0 to 4. 0 represents 0% improvement/worse, 1 is 1-25% improvement, 2 is 26-50% improvement, 3 is 51-74% improvement, and 4 is >75% improvement. | 7 subjects were lost to follow up. 3 subjects withdrew. 1 subject cancelled multiple appointments and could not come in. | Posted | Mean | Standard Deviation | score on a scale | 1 Month Post Last Treatment |
|
Adverse Events occurring will be captured and followed throughout patients' participation in the study, approximately 17 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 | 755nm Alexandrite Laser 755nm Alexandrite Laser: 755nm Alexandrite Laser |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | Nervous system 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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| ID | Term |
|---|---|
| D053844 | Lasers, Solid-State |
| ID | Term |
|---|---|
| D007834 | Lasers |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | 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. 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 | Photographic Evaluation of Scar Clearance | The échelle d'évaluation clinique des cicatrices d'acné (ECCA) Grading scale was used to evaluate the photographs, using 2D and 3D photography, where the scale ranges from 0 to 4. 0 represents 0% improvement/worse, 1 is 1-25% improvement, 2 is 26-50% improvement, 3 is 51-74% improvement, and 4 is >75% improvement. | 9 subjects were lost to follow up. 3 subjects withdrew. 1 subject was not done due to patient's non-compliance. 2 subjects did not record overall clearance for this follow up. | Posted | Mean | Standard Deviation | score on a scale | 3 Months Post Last Treatment |
|
|
|
| 0 |
| 33 |
| 0 |
| 33 |
| 17 |
| 33 |
| Redness | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Swelling | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Crusting | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Blistering | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Hypopigmentation | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Hyperpigmentation | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Pruritus | 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.